Pipelines to Pacemakers: Defending Our Medical Devices with Help From the Energy Sector

The FDA dropped a bombshell on the health care industry last month, and companies are missing the quickest and easiest way to respond.

The FDA's latest recommendation (June 13, 2013) that "medical device manufacturers and health care facilities take steps... to reduce the risk of failure due to cyberattack," has the opportunity to cause a wave of waste and expensive false senses of security unless approached with a proven risk process for securing these types of devices.

The FDA specifically called out both medical device manufacturers and health care facilities together, as they collectively create the attack surface for advisories to breach. While the level of cooperation and collaboration between those two groups has been strong in many other areas, they have not yet become tightly coupled with regard to security. Security is not an either or game, and since complete eco-systems are being attacked, complete eco-systems must be secured.

Unlike the medical industry, the energy sector -- from pipelines to oil rigs to power grids -- has long been at risk due to the relatively small industrial control systems, or ICS, that perform much of their automated decision making. While the form and function of a pacemaker and an oil pipeline are very different, the approach to securing them can be highly symbiotic. These third-party ICS are implanted into the body of an oil rig or pipeline, and then left to open and close valves, start and stop pumps, and other low level but crucial tasks. In the energy space, a false command to a valve or a pump can cause blackouts, oil slicks, or toxic clouds.

To protect against threats to these ICS risks on an oil rig, we routinely follow precise standards and practices to help us identify and prioritize risks, develop and deploy specific countermeasures to address those risks, and then build and operate a life-cycle approach to security that accounts for the real world changes to environments and threats. While nothing is absolute in the security business, this proven approach provides the optimum way to manage the risks associated with the energy industry's industrial control systems.

Just like with the industrial side, our "human" control systems are called Implantable Medical Devices (IMDs), and a false command to a valve or a pump in our bodies can cause instant death. As Dr. Robert Wah, president-elect of the American Medical Association says, "We are now seeing computers being used in human hearts and brains and other parts of the body. The need to protect against cyber attacks is obviously vital. The term 'life or death situation' is the daily norm here." Since the 1960s, a change to a pacemaker required cutting open the patient, modifying the device, and then stitching them back up. In what seemed a great breakthrough only a few years ago, implantable medical devices like pacemakers added the capability for a wireless update, that saved countless surgeries. Fewer surgeries sounds good until you start to think of the cybersecurity ramifications, which have moved a wireless pacemaker attack from a research paper, to a hit television drama, to reality -- in only five years. It's now possible to kill over the Internet, and with an estimated 86 million connected medical devices [Mocana.com around the world, it's a problem that must be addressed now.

"Implantable Medical Devices (IMDs) are increasingly a routine part of high quality healthcare delivery, and are being used regularly to help hearts to beat, ears to hear, drugs to be delivered, nerves to be stimulated, and more every day. By leveraging the energy sector's decade-long progress, we can give the healthcare eco-system the best chance to live up to the Hippocratic Oath: First, do no harm," says Marc Probst, CIO of InterMountain Healthcare So what did the energy sector do 15 years ago when they realized their industrial control systems (ICS) were easily attackable? After some years of quiet contemplation and discussion of the reality of such future attacks, they launched a multistep process to 1) identify the most at risk devices in the field, 2) work to replace them with newer, more secure devices, and 3) build out industry-wide standards on how best to develop and deploy secure ICS across their ecosystem. It is these resultant standards, worked on by many and brought forth by the International Society of Automation and known as ISA-99, that can help the medical device ecosystem just like it has helped in Energy and other sectors.

While it may seem odd to view the security of a medical device in the same way you do a valve on an oil rig, the advantages to everyone are enormous.

Lower risk for the patients, device manufactures, and healthcare providers Faster implementation of improved security Trusted ICS workforces to lead the change Better sharing of security information Leverage of Homeland Security (DHS)'s ICS-CERT Easier regulatory compliance Greater confidence by all Treating medical devices like ICSs and applying the ISA-99 standards and other lessons learned from a decade of protecting energy-centric devices allows us to more securely develop, test, deploy and document the entire life sciences ecosystem. This will improve corporate cooperation, foster greater innovation, and support the use of medical devices in the most trusted and efficient manner. And most importantly, it will give patients the real assurance that these devices will 'do no harm.' The FDA's June 13th guidance is just that today, guidance. While not yet regulation, it behooves all the players -- manufacturers to providers-- to move swiftly, urgently, collectively, and with a methodical process that gives everyone the best chance to succeed. The good news is there is now an available blueprint for that success.

Tom Patterson is the author of Mapping Security, and is a globally recognized security expert, having worked on security and critical infrastructure protection for three decades. Tom currently serves as the Director of CSC's Global Cybersecurity Consulting division.

Pipelines to Pacemakers: Defending Our Medical Devices with Help From the Energy Sector 1

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Why Are Flex PCBs Used in Medical Devices and Wearables?
Why Are Flex PCBs Used in Medical Devices and Wearables?
Flex PCBs have mechanical advantages over rigid PCBs in various medical applications. • None Flex PCBs allow the engineers to mount the various electronic components like microphone, battery, camera in a tiny and compact package. As a result, the entire end product (medical device) can be placed on a human body (for example, hearing-assist devices). • None A flex circuit can be formed in complex shapes in three dimensions with branches to multiple connectors, which would be impossible to achieve with a rigid PCB. • None Flex circuits can be interfaced with rigid boards without the relatively tall and bulky connectors flat cables require, or in the case of rigid-flex construction. • None They can be integral with the boards and eliminate external connectors altogether.How does virus attack human's body?Most viruses enter humans through droplets in the air that we breathe. From there it attaches to the surface of the lung sacs (alveoli) and enters the capillaries of the lungs directly. The flu virus will follow this mode of entry and many other air-born viruses. Rotavirus cause diarrhea in children. It gets swallowed and enters the body through the lining of the gut. Hepatitis A and B are transmitted through the gut also, but hepatitis C is transmitted through mucous membranes or injections into the blood stream.In essence the virus transmits itself into a cell: Virus Cell-to-Cell Transmission.system of heart in human body?the heart is a part of the circulatory system -- it is the key reason of us being able to breathe and live! It pumps blood throughout your whole body - to the tiniest veins and arteries in your fingertips to the biggest and strongest muscles in your thighsIf a human body was left on the moon completely untouched, would it stay the same forever?The bacteria that is present in our bodies would decompose the body partially. Moreover it depends on where the body is - if it is on side of sun then it would burn off , but if it is on other side then it would freeze to a thickened mass , eventually being decomposed. There are almost 1000 meteorites falling towards the moon at a single instant , so there is a great probability of body getting hit by meteorite . The harmful radiations like gamma UV cosmic microwave etc. will easily penetrates moon's very thin atmosphere and would eventually damage the body by burning or speeding the decomposition. (i dont know about aliens , if they exist then u cant imagine wats gonna happen !)Need help in the human body!!!!!!!!!!!!!?look at the book called Grey's AnatomyCan a human's body evolve quicker then Normal when?EDIT: If you understood what I said the first time you would understand that many variables are working here. I explained that mutations arise due to mistakes in replication (vast majority). I explained how a gene could evolve more slowly or more rapidly. To be rapid it would have to be non essential (not many interacting partners), so then we would not expect "one gene or the cause of evolution in the humans". If "one gene" is extremely important then it will probably have many functions in many different cells ; THIS RESTRICTS THE RATE OF EVOLUTION of that gene [as I said]. So it is not so much a case of "impossible side of the community" but your inability to understand basic evolutionary principles. Let me take the bait though: "Let's say a particular combination of many genes (more realistic) in an individual made them immune to all pathogens (extremely unlikely, but you do not care). So since this is really rare, as soon as this person mated. The combination would change from the individual and the offspring, it would likely end right there if it ever even did happen(plus other people in the population wo not have this perfect combination). But let's pretend that enough people did have it, then you are right this could cause dramatic evolution so more and more people had this combination of genes. But if everyone had it; what makes one person more fit than the other? If we are all the same, then we are prone to the same failures. We need variation to survive." I have run out of room to write. I have stripped down my original answer below to just important parts. Interactions between 'us' and other organisms do not evolutionarily 'hold us back'. Evolution concerns the genome(DNA), since it is the only thing passed on over time. The genome communicates with the external environment via encoding information [via sequence if letters/bases/nucleotides] to make functional products (like proteins and RNA). Different individuals can have slightly different sequence of bases in a gene, this can cause the functional product of the gene (i.e. the protein/RNA that the gene encodes) to have slightly different functional properties (like how well it does its job). Functional products are defined based on their specific function(s), but function can mean different things in different environments. Since mutations are random, if one happens in non-coding sequence it may not have an effect. But if it occurs in a coding region then chances are, it will affect the function of the encoded protein. Changes within a gene will not be distributed evenly across that length of that gene. If a change occurs, it will be tolerated less if that change affects the site where the encoded protein interacts with another protein. So if a protein interacts with lots of different proteins, it will evolve very slowly. Changes in DNA of a gene can cause differences in the sequence of amino acids in the encoded protein. These can affect protein structure and function depending on the specific change (small positive amino acid to large negative one = probably bad). Therefore, different regions of genes evolve at different rates based on that proteins structure, function and environment. If these changes are in a region of the sequence which is important for the protein function, it will evolve at a lower rate than the rest of the protein. When we consider something like a virus, remember that it uses our proteins (encoded in our DNA) to do its job. Some viruses use our polymerases (we use them to copy our DNA), but because it is an essential protein, it evolves very slowly (hard to become immune this way!). Some viruses shut off our cells ability to make endogenous proteins but only synthesise viral proteins (sneaky move!). They do this by inhibiting one of our very important proteins. So we cant just change the protein because it would be catastrophic to normal cellular function. Some viruses enter the genome, some jump around and can actually lead to genome evolution. [Please note how viruses use fundamental features, they target essential proteins which we can not change very well, so these viruses may tend to win when they are inside the cell. That's why we have evolved mechanisms such as production of proteins which can halt the virus from entering the cells in the first place. These proteins can change more rapidly since they have more dedicated functions and have evolved further mechanisms (shuffling parts of these proteins around) to cope with all the different pathogenic/foreign objects which may enter our system. This shuffling mechanism is great in context of what the proteins function is (binding lots of different things) but if we shuffled the sequence in a gene for polymerase then it would wreak havoc on the cell, it would not cope, more damage than good would occur most (practically all) of the time.]
2021 09 13
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Advanced Medical Devices Are What You Need to Succeed
Advanced Medical Devices Are What You Need to Succeed
The medical science is developing and you as a health care provider should always empower you with the advanced tools and medical devices.If you are dealing with musculoskeletal disorders, then you have to find tools like orthopedic braces to position and stabilize specific body Parts, muscles, and joints. However, you need to source the devices from the Orthopedic Implants Manufacturers Company. Let's find out how you should go about it.Choose a certified company for quality assurance:When you are looking for sourcing medical devices, you need to find a certified company for quality assurance. For instance, CE and ISO certified companies can produce better quality medical devices since they have certain standards to follow acceding to each certification. In addition, you should also be looking at the ideology of the manufacture because a company that believes in quality would be able to offer you smart devices irrespective of the certification. In fact, it depends upon the perception that the manufacturer carries. In a nutshell, quality should be your priority while sourcing the products. The approach must be creative and organized:• If you want to source and avail the best products and devices then you should be looking at how innovative the manufacturer is.• A company that is driven by innovation might just come up with gen-next devices. And that would be possible only when they are organized. • Being organized would mean the manufacturer should and must have a good manufacturing unit equipped with advanced tools.• They should also have the perfect talent pool and expert professionals to carry out the manufacturing process. It should be a perfect combination of human resources and technological resources. Reputation should be good:This is one of the vital aspects that you should be looking at while sourcing devices. A company that operates on a global level should be your preference because they would know what exactly you need. Hence, you have to find out how big the company is and their global presence along with the client list to ensure that you are sourcing from the reputed and expert manufacturer. Climactic suggestion:The above-stated points should ideal help you in getting the best Orthopedic Implants equipments manufacturers in India. But the crux of the matter is that you have to have the best quality devices and that is possible only when you know what and where to look for the right orthopedic devices so that you get the right deices for better treatment.We are leading Hospital Medical Bed Furniture manufacturing company in India. For More Details Please Visit Our Website.#OrthopedicImplantsManufacturers #OrthopedicImplantsSuppliers#OrthopedicImplants#OrthopedicImplantsEquipmentManufacturers#HospitalBedManufacturersCompany#HospitalFurnitureManufacturersCompanyDo you think that people are slowly losing their freedom?No privacy, no freedom, and some say there are devices that can do things that are out of a comic book or somethingstylistic devices in to kill a mockingbird?a million. Mr. Cunningham, i think of. I study this e book some months in the past- no longer on a school task, nevertheless. 2. i be attentive to that is not any longer the 1st one or the final one. 3. study to her 4. i do no longer undergo in recommendations. 5. Calpurnia- black maid Nathan Radley- Boo's brother Mayella- Bob Ewell's daughter Cunningham- undesirable classmate 6. do not be attentive to 7. do no longer undergo in recommendations 8. do no longer undergo in recommendations 9. smash's her camillias 10. i think of it somewhat is a greenback and corn... i do no longer undergo in recommendations 11. he's old 12. Boo Radley 13. do no longer undergo in recommendationsWhy doesn't the camera bounce around when the camera crew follows someone or something?For movies, they use a variety of devices like a dolly or a steady-cam harness. A dolly is basically a small car on tiny train tracks so it can roll smoothly back and forth, following an actor or other object through a scene. A steady-cam harness straps the camera to the camera operator, and has a variety of computer controlled arms with counterweights. This way, as the camera operator moves along, the camera remains steady, not bumping around. If you watch the "making of..." extras that are included on many movies, you will see both of these in use, especially if the movie has a lot of stunts or special effects in it.
2021 09 13
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Sterilizing Medical Devices
Sterilizing Medical Devices
The best sterilization process for a medical device depends on the materials and methods used to assemble it.When it comes to sterilizing medical devices, material compatibility is the Achilles' heel."Steam is probably the best sterilization method," notes Clark Houghtling, who has worked in the sterilization industry for 40 years. But steam, technically known as moist heat, has limited use because few materials in medical devices can take the high temperature. Moist heat sterilization is often limited to products that consist of metal, glass and certain plastics that withstand high temperatures.In contrast, ethylene oxide (EO) is the "most material-friendly sterilant," insists Houghtling, the vice president for business development and technical affairs at the Cosmed Group, which provides contract sterilization services and supplies to medical device manufacturers. "It does not alter the physical structure of the component."Because it is so material-friendly, EO currently accounts for more than 50 percent of industrial product sterilization, Houghtling estimates, adding that gamma radiation is the other big player, accounting for more than one-third of the market.Despite being material-friendly, EO does have two minor limitations, Houghtling says. Because EO is a gas, it cannot be used to sterilize liquids, and it cannot be used on devices that are in gas-impermeable packaging.Another gas sterilant, nitrogen dioxide (NO2), is incompatible with cellulose materials, such as paper and cardboard, explains physicist David Opie, Ph.D., the senior vice president for research and development at Noxilizer Inc. NO2 also changes the chemical structure of polyurethane and nylon, as well as polyoxymethylene, which is commonly known by the brand name Delrin.With radiation sterilization, the biggest concern is the effect on polymers, such as certain plastics like polytetrafluoroethylene, commonly known as Teflon."[Radiation] will create bond breakages in long-chain polymers," says nuclear engineer Mark Smith, the managing director of the private radiation consulting company Ionaktis LLC. Caused by free radicals formed during irradiation, these breakages can make polymers more brittle, change their temperature characteristics, discolor them, and limit their shelf lives. Radiation also can change the fluid properties of plastics.Glass will change colors when irradiated, Smith adds, noting the metal ions in glass will dictate the new color. Clear glass, for example, may turn brown. He recalls an incident in which a manufacturer used radiation to sterilize clear glass syringes but the glass turned so dark that the black gradation markings could not be read.Material incompatibility can be addressed by adjusting the manufacturing process to accommodate the sterilization method. The syringe manufacturer that Smith noted decided to change the gradation markings to white so that they were easier to read. Medical devices sterilized with NO2 are placed in their cardboard packaging after the devices are sterilized. And when gaseous sterilants are used for devices that contain liquids, the liquids are typically sterilized in their containers by radiation prior to the containers being incorporated into the devices.Alternatively, the sterilization method could be switched to one compatible with the materials, or the materials could be replaced with ones compatible with the chosen sterilization method. However, Houghtling points out, switching materials to address the limitations of a particular sterilization method almost always results in higher raw material costs."Nylon, polyurethane and Delrin-you can not say those are uncommon materials," Opie admits, noting that NO2 was not introduced as a sterilizing agent until approximately three years ago. "Other sterilization methods have the benefit of 30 or more years [during which] medical device engineers [have become] attuned to the incompatibilities and, just by nature, do not select incompatible materials.... Until NO2 gets more mainstreamed and people start avoiding nylon, Delrin and polyurethane, then we will always be challenged with asking people to change the materials."Radiation physicist Chris Howard views different sterilization methods not so much as having advantages over one another but as being complementary. "There are certain products that do not mix well with radiation, and there are certain products that do not mix well with ethylene oxide," says Howard, who works at Nordion Canada, which provides gamma technologies and medical isotopes to sterilization facilities in approximately 40 countries.Sometimes, the molecular changes caused by sterilization methods are beneficial. Gamma radiation, for example, is used to harden the ultrahighmolecular- weight polyethylene used in orthopedic implants like artificial hips and knees so that the implants will last a long time. "Those products are given healthy doses of gamma radiation several times to make them very dense so they have better wear properties," Houghtling says.The goal of all sterilants is to either kill microorganisms or make them incapable of replicating. "You can have one bad germ, but if it can not reproduce itself, it means nothing," Opie adds.Typically, medical device manufacturers design their methods to achieve a sterility assurance level (SAL) of 10-6. At that level, the chances are one in a million that one microorganism remains viable, explains Smith, who has more than 30 years of experience in the field of radiation.To reach such a SAL, different sterilization methods take different approaches.Conventional EO sterilization, for example, historically relied on a three-phase process that begins with preconditioning. Pallets of medical devices are placed in a room, chamber or cell, where they are exposed to heat and humidity for a defined period to acclimate the devices to the sterilization conditions and to make the microorganisms more susceptible to the sterilization process.In the second phase, the pallets are placed in a sterilizer, which can range from the size of a tabletop to a full tractor trailer. The medical devices are sterilized in their final packaging, typically corrugated cardboard boxes.In the United States, most EO sterilizers use 100 percent EO, as opposed to a blend of EO and carbon dioxide, Houghtling notes. When 100 percent EO is used, the process is done under vacuum, creating an environment that is lower than atmospheric pressure. After air is removed from the sterilizing chamber and humidity added, EO is introduced. Several hours are required for EO to permeate throughout the load and kill microorganisms to the designated SAL. EO is then flushed out of the chamber.For EO sterilization, it's essential that devices are packaged in gaspermeable sterile barriers. The pores in the barriers are large enough to allow EO to flow in and out but too small to allow microorganisms in. As a consequence, once EO kills the existing microorganisms on the devices, the devices remain sterile until their gaspermeable barriers are opened.The last phase of EO sterilization is aeration to further remove EO. This is done in a room, chamber or cell with heat, but without humidity. Aeration reduces EO concentrations to or below permissible levels for the safety of both the workers who handle the devices and the patients who are treated with them.Coming more into vogue in EO sterilization is all-in-one processing, in which all three phases take place in the sterilizer instead of in three different areas. The all-in-one process is safer for workers because they do not move the pallets until the product is nearly fully aerated. It also reduces process deviations and product damage.On the other hand, because the entire process is executed in a sterilizer, the amount of time that the devices are in the sterilizer roughly doubles, cutting throughput in half. So to process the same volume, all-in-one processing requires roughly doubling the number or size of the sterilizers. In addition, sterilizers are much more expensive than preconditioning and aeration areas.However, the time required for EO sterilization can be reduced significantly by combining all-in-one processing with dynamic environmental conditioning (DEC), parametric release and inchamber aeration, Houghtling notes.DEC, which works best for products that can withstand deep vacuums, can be used to more quickly and evenly heat and humidify product loads. Parametric release eliminates the need for using biological indicators to monitor whether the designated SAL was reached, which typically takes two to seven days. In addition, the dynamics of the sterilization chamber can be used to speed up aeration, resulting in more rapid dissipation of residual EO."It can take a process that may occupy five to 10 days and shorten it to perhaps one day," Houghtling reports. "This is arguably the biggest advance in the EO sterilization process since its beginning in the 1950s."The phases of NO2 sterilization mimic those of EO, with a major difference being that medical devices are not sterilized in their cardboard packaging. Consequently, NO2 sterilization is more likely to be done in house than outsourced.Opie notes that two-door sterilizers can be used to batch-sterilize medical devices in line. The devices are manufactured and packaged in sterile barriers in a clean room, moved into an NO2 sterilizer through its loading door in the clean room, sterilized, and removed through the opposite door into a normal manufacturing area to be packaged and labeled."You want the size of the sterilizer to match the speed of the packaging line," Opie says. "If you have a two-hour cycle for sterilization, for example, then you need two hours' worth of product to fit in the chamber."While EO and NO2 sterilization takes place in sealed chambers, radiation sterilization typically takes place within a concrete shield approximately 2 meters thick. Packaged medical devices travel through an entrance in the shield on a conveyor that takes a series of turns before reaching the radiation source in the inner chamber of an irradiator, Smith explains. Radiation does not escape from the shielded area because it is absorbed by the concrete walls.The most common source of radiation for sterilization is cobalt-60.Small rods of cobalt-60 are stacked in a column that is encapsulated by two separate layers of stainless steel. Each "pencil" of cobalt-60 is approximately 18 inches long and 0.375 inch in diameter.Several pencils are placed in the source rack of an irradiator. As the cobalt-60 decays, more pencils are added to maintain the irradiator's strength. Eventually, pencils are replaced either because they have decayed too much to be useful or because the source rack no longer has room for fresh pencils.Cobalt-60 emits gamma rays at a steady rate in all directions as it decays. Consequently, products like packaged medical devices are circulated around the source rack. The gamma rays penetrate the products and damage the DNA and other cellular structures of microorganisms.Other forms of radiation used to sterilize medical devices include electron beam (e-beam) and X-ray. Both are generated by accelerators, not radioactive sources. An X-ray irradiator is essentially an e-beam irradiator in which electrons pass through a target that converts the electrons to X-rays. X-ray's ability to penetrate products is comparable to gamma, while e-beam penetrates only a few centimeters.Unlike gamma, both e-beam and X-ray are directional. "If you want to irradiate a product with electron beam or X-ray, your beam is pointing straight at it," Smith says. Consequently, products can be sterilized one box at a time with e-beam and one container at a time with X-ray.E-beam and X-ray deliver energy at a higher dose rate than does gamma. This allows free radicals to form and recombine more quickly, reducing degradation in such materials as oxygen-permeable polymers."At a slower rate, there's more time for the oxygen to permeate through a polymer...which then creates the oxygenation reaction and creates more degradation," Smith explains. "With electron beam in particular, you are doing that fast enough that the oxygen does not have [as much] time to go in and react to those free radicals."One major advantage radiation has over gaseous sterilants is speed. Large radiation facilities can typically sterilize products in one to two hours."[EO facilities] have to allow for the gas to dissipate after the product has been exposed to it. That can take days in some cases," adds Terry Kehoe, Nordion's senior account manager.In contrast, irradiated products are safe to use as soon as they come out of an irradiator.With radiation sterilization, sterile barriers do not need to be gas-permeable. Foil packaging can be used instead, which is especially critical for medical products that should not be exposed to relative humidity, such as bioabsorbable products.For better and worse, gamma radiation cannot be turned off, unlike e-beam and X-ray. For safety, radioactive pencils are transported in heavily shielded shipping containers. And any time a gamma irradiator is not being used, the cobalt source rack is lowered into a pool of water to contain the gamma rays.On the other hand, because cobalt-60 is not dependent on an outside power source, it is reliable, simple, and easy to control, Howard says. It also produces very repeatable results.Another advantage is that gamma irradiators require relatively few spare parts. "Cobalt is a fairly simple design. You've got a conveyor. You've got something that moves the sources up and down. That's pretty much it," Smith says. "For e-beam and for X-ray, you've got a whole particle-accelerator system...so there are a lot more spare parts."Unlike gamma irradiators, e-beam and X-ray accelerators require an "astronomical" amount of electricity, Smith says. As a result, accelerators produce a great deal of heat and must be water-cooled.While EO is more material friendly than other sterilants, it is flammable and explosive. EO sterilizers must be located in areas built with damage-limiting construction and intrinsically safe electrical fixtures.In addition, EO is harmful to people at low doses, and it is labeled carcinogenic, notes Noxilizer's Opie. In contrast, NO2 is harmful to people at high doses, so it is easier to reduce NO2 concentrations on medical devices to safe levels during aeration than to reduce EO concentrations."All the regulatory agencies around the world are putting much more strict limitations on human exposure to stray ethylene oxide," Opie says. "You have to have a full respirator on to handle those products in a lot of places right now."A critical advantage of NO2 over EO is that NO2 sterilization can be conducted at low temperatures, without a deep vacuum and in a relatively short time. As a consequence, NO2 can sterilize the exterior surfaces of syringes and other drug-delivery systems with minimal to no effect on the medicine in those systems.Elastomeric closures, such as pistons in syringes and stoppers in vials, are vulnerable points in drug-delivery systems. "EO goes right through those elastomeric closures and contaminates the contents," Opie says.Ultimately, the best sterilization method is the one that works best for each particular product. "All sterilization methods have value when they work effectively and efficiently," Houghtling says. "Several key factors, such as material compatibility, cost and turnaround time, need to be analyzed, and then the optimum method can be selected."For information on how to obtain reprints/e-prints of this article, please contact Jill L. DeVries at devriesj@bnpmedia.comImprove and boost the wifi connection to public hotspotsSome devices allow you to connect an external antenna to your wireless device. If you can do this, that is the "Low hanging fruit" method I would recommend. There are many types of antennas so you will have to choose based on exactly how you would like to boost your performance. Typically most antennas in these types of devices are omnidirectional and that is usually appropriate under most circumstances. A directional antenna can provide a much stronger signal from a distance but requires alignment to the wireless device it is connecting to.Another method you might try is to figure out where the receiver is on the USB device and fashion a parabolic focuser that will capture the signal and focus it on the receiver in a similar manner as a satellite dish or directv setup. The parabola need not be huge. You are just trying to create a reflector that collects EMI from the right direction and also reflects everything you transmit in the wrong direction back at the device you are trying to connect through. Hope this helps
2021 09 13
Magbasa pa
Cybercriminals Could Hack Nhs Medical Equipment to Stop Patients' Treatment Or Make Them Overdose, I
Cybercriminals Could Hack Nhs Medical Equipment to Stop Patients' Treatment Or Make Them Overdose, I
Cybercriminals could hack into medical devices used in NHS hospitals, security specialists have warned.The US-based cybersecurity firm CyberMDX lifted the lid on security flaws in hospital wards' workstations which are connected to the internet.NHS trusts have been warned hackers could gain access to medical software that would enable them to control and cut off IV pumps.This could lead to 'catastrophic' consequences if they were to block the delivery of chemotherapy drugs or tamper with insulin doses, one expert said.Jon Rabinowitz, vice president of marketing at CyberMDX in New York, wrote in a blog post: 'An attack of this sort can allow an attacker to disable the workstation.'[And] disrupt the flow of electricity to care-critical infusion pumps, falsify pump status information (vital for the nursing staff) and in some cases even alter drug delivery.'In other words, if compromised, these simple mounting poles can potentially harm patients.' The machines are electronic and connected to both nurses' computers and to IV drips hooked up to patients.Vital medicines such as chemotherapy drugs and insulin for diabetic patients may be administered through the machines, which control the dose, timing and speed of injection.Cybercriminals do not appear to have gained access to any NHS devices so far.However, Professor Alan Woodward, a computer security expert at the University of Surrey, told The Times an attack would be 'catastrophic if successful'.But he addedthe risk is low due to medical devices 'often taking a lot of extra circumstances to exploit'.Hacking across any industry can occur for financial gain, to gather information, as a form of protest or just 'for the fun of it'.'Attacking medical devices is an odd area for motive,' Professor Woodward said.'The most likely attackers are those doing it to see if it can be done.' Concerns over the security of NHS computer systems have been rife ever since more than a third of hospital trusts had their systems crippled in the WannaCry ransomware attack in May 2017.Nearly 20,000 appointments were cancelled after the health service failed to provide basic security against cyber attackers.The virus, which spread via email, locked staff out of their computers and demanded £230 ($289) to release the files on each employee account.Five A&E departments even had to divert ambulances away at the peak of the crisis.In the current threat, successful hackers could get access to hospitals' networks.This could enable them to introduce their own computer programs hidden inside harmless-looking software updates, enabling them to take control.They may also be able to get hold of patients' private information.NHS Digital has published guidance for IT teams to repair any risky systems and claims it is contacting trusts to make them aware of the issue.The workstations were made by a company called Becton Dickinson in New Jersey, US.The manufacturer claims the flawed system arose due to a previously disclosed error in the Microsoft Windows CE operating system.Software updates that reduce the risk of hacking are often slow to be installed due to a lack of understanding, insufficient resources or the sheer number of devices that need to be 'fixed', Professor Woodward said.The NHS declined to say how many workstations may be affected.The Medicines and Healthcare Products Regulatory Authority claimed it was unaware of any real-world attacks on medical devices.MailOnline has contacted NHS Digital for comment.
2021 09 13
Magbasa pa
Brexit to Harm UK's Cherished Health Service, Experts Say ...
Brexit to Harm UK's Cherished Health Service, Experts Say ...
LONDON, (Reuters) - A British exit from the EU without a deal would have "an immediate and drastic" impact on availability of medicines and vaccines as well as affecting health system funding and staffing, experts warned on Monday.Although a no-deal Brexit was the worst scenario, even a negotiated divorce from the European Union would also damage the National Health Service (NHS), the experts said in a review published in The Lancet journal.Britain is scheduled to leave the bloc on March 29th, and Prime Minister Theresa May has yet to secure parliament's backing for her negotiated EU withdrawal agreement.The Lancet review, led by three UK health policy specialists, found that even under this deal or potential variations of it before the deadline, Brexit's health impact would be only slightly less harmful than in a no-deal scenario."Some people will dismiss our analysis as 'Project Fear'. But with just over a month to go to Brexit ... it just isn't good enough to keep saying that 'something will work out' without any details of exactly how," said Martin McKee, a professor at London School of Hygiene & Tropical Medicine who co-led the review.The analysis used available legal and political texts on four Brexit scenarios to assess likely impact on the state-funded NHS, a much-cherished though increasingly strained pillar of Britain's welfare services.It found that one major problem from Brexit under all scenarios would be staff recruitment and retention - in part because few provisions have been made for immigration of health workers to the UK or for long-term recognition of professional qualifications.It also said that "under a no-deal Brexit, the absence of a legal framework for imports and exports is expected to have an immediate and drastic effect on supply chains" for medicines, vaccines, medical devices and equipment.Despite government assurances, the analysis said, shortages would be likely because stockpiling cannot cover more than a few weeks and some products - such as radioisotopes used in medical imaging for diagnosis - cannot be stockpiled.The British government has asked UK drugmakers to build an additional six weeks' worth of stockpiles to prepare for any no-deal Brexit, a target the industry has said will be challenging.The review said that as one of the largest areas of public spending, any negative impact on the economy - however short-term - would put extra pressure on health service financing.
2021 09 13
Magbasa pa
In India, for India: Medical Device Makers Plug In
In India, for India: Medical Device Makers Plug In
BANGALORE (Reuters) - In a sleek glass and chrome building in Bangalore's software hub, the more than 1,000 young researchers and engineers at GE Healthcare could hold the keys to innovations that save lives in India's vast hinterland.The 50,000-sq. ft. R&D facility, GE Healthcare's largest, recently launched the MACi, a portable electrocardiogram (ECG) machine that weighs less than 1 kilo and runs on a battery even in hot, dusty conditions, enabling ECGs at just $0.20 each compared with around $50 currently.The MACi, and its slightly heavier predecessor MAC 400, were designed, developed and manufactured with local components in India, where greater healthcare spending is boosting medical systems makers like GE, which are now focusing on making products for India.The market for medical devices is worth up to $3 billion and growing at more than 10 percent a year, according to PriceWaterhouseCoopers (PWC), drawing foreign firms such as GE Healthcare, a venture with Wipro, Siemens and Philips, which are also pursuing a local-for-local strategy in India."In theory, the opportunity is huge," says Sujay Shetty, leader of the pharma practice at PWC in India."In India we want first-world technology at third-world prices. So India can also be a springboard for Africa and Latin America, which have similar needs," he said.India's healthcare industry, estimated at more than $30 billion, will double in value in five years, according to PWC.For a graphic on India's expenditure on health, click here GE Healthcare first assembled high-end ultrasound, CT and X-ray machines and adopted an "in country, for country" policy earlier this year at its sprawling John F. Welch Technology Centre in Bangalore, with a staff of 2,200 focused on India."So far, innovations were geared toward the United States and Europe and artificially pushed into the Indian market," said Ashish Shah, general manager, GE Healthcare's global technology."Today, we innovate for India in India, thinking in rupees and paise rather than dollars and cents," said Shah, who took on this job after more than 15 years with GE Healthcare in the United States.India spends just over 5 percent of its $1-trillion-GDP annually, largely in primary healthcare focusing on basic needs such as immunisations and common illnesses.The per capita expenditure is less than a third of what China spends, while the private sector accounts for about 80 percent of total spending in India's healthcare.India is an emerging medical tourism destination, with modern hospitals in cities offering premium care at prices that are a fraction of those in the west, but it has just 0.7 hospital beds and 0.6 doctors per 1,000 people, well below the world average.The government has launched a National Rural Health Mission and an insurance scheme for the very poor, and is encouraging public-private partnerships (PPP), particularly in small towns, where people have to travel long distances for blood tests and X-rays.Traditionally, NGOs and large corporations have partnered hospitals or aid agencies in rural areas, helping bridge the gap.One example is Lifeline Express, comprising five carriages on a train, kitted out with facilities including an operation theatre. Backed by UK charity Impact Foundation, it has performed more than 600,000 surgeries in nearly 20 years.Now, medical systems makers like GE Healthcare and Siemens, who have for years sold high-end equipment to local hospital chains such as Apollo, Fortis Healthcare and Max, are keen to tap this opportunity, as well.Siemens, which has manufactured imaging and ultrasound systems in India for more than 50 years, has built mobile diagnostics units with X-ray, ultrasound and pathology systems.The PPP model would work to take quality healthcare to the masses, but there is no framework yet, plus there is no national policy or fiscal incentives for local manufacture, said D. Ragavan, executive vice president at Siemens Healthcare.GE has a pilot CathLab on Wheels, which a leading cardiac surgeon and the Indian Army helped build. In two-and-a-half years it has served about 2,500 patients, performing routine exams and complex angiographies, all in a space no bigger than a bus."We can't survive in an emerging market like India selling what we make in developed markets because there's a huge dichotomy between the need for healthcare and ability to pay," said V. Raja, chief executive of GE Healthcare in south Asia.This is the gap GE's MAC 400 and MACi seek to bridge: Heart disease is a leading cause of death in India, and with these ultra portable devices, ECG testing - the first step in early detection - is made affordable and accessible to millions.The MAC 400 costs about $1,000, or one-third the price of an imported equivalent, and has sold more than 8,000 units since its launch in 2008. The MACi, smaller and lighter, costs about $500.There are some 700 medical devices makers in India, but most make low-value products such as needles and catheters, leaving specialist products to foreign firms like GE, who are considering taking their in country-for country policy to other markets.GE has also built baby warmers for India where infant mortality is high, more than halving costs with local components and fewer features."For something to work in India you don't need all the bells and whistles," said Raja, picking up a MACi, which is no bigger than a credit card scanner and has fewer buttons.The strategy has opened up a bigger market, he said, backing the "fortune at the bottom of the pyramid" theory that there is money to be made even among poorer consumers, which companies from Nokia to Nestle have embraced.Healthcare infrastructure expenditure in India in 2013 will hit $14.2 billion, a recent KPMG report estimated, a near 50 percent increase of the 2006 total, helped by new technologies, the growth of hospital chains and increased government spending.GE Healthcare, Siemens, Philips and others are ready."We are at an inflection point and have the opportunity to do what telecom did: grow exponentially by addressing a mass need with the right quality products at the right price," Raja said.(Editing by Alistair Scrutton and Dhara Ranasinghe) (For more news on Reuters India, click in.reuters.com
2021 09 13
Magbasa pa
Spinal-cord Stimulators Help Some Patients, Injure Others
Spinal-cord Stimulators Help Some Patients, Injure Others
Columbia, South Carolina (AP) -- Desperate for relief after years of agony, Jim Taft listened intently as his pain management doctor described a medical device that could change his life.It wouldn't fix the nerve damage in his mangled right arm, Taft and his wife recalled the doctor saying, but a spinal-cord stimulator would cloak his pain, making him "good as new." Taft's stimulator failed soon after it was surgically implanted. After an operation to repair it, he said, the device shocked him so many times that he couldn't sleep and even fell down a flight of stairs. Today, the 45-year-old Taft is virtually paralyzed, a prisoner in his own bed, barely able to get to the bathroom by himself."I thought I would have a wonderful life," Taft said. "But look at me." For years, medical device companies and doctors have touted spinal-cord stimulators as a panacea for millions of patients suffering from a wide range of pain disorders, making them one of the fastest-growing products in the $400 billion medical device industry. Companies and doctors aggressively push them as a safe antidote to the deadly opioid crisis in the U.S. and as a treatment for an aging population in need of chronic pain relief.But the stimulators - devices that use electrical currents to block pain signals before they reach the brain - are more dangerous than many patients know, an Associated Press investigation found. They account for the third-highest number of medical device injury reports to the U.S. Food and Drug Administration, with more than 80,000 incidents flagged since2008.Patients report that they have been shocked or burned or have suffered spinal-cord nerve damage ranging from muscle weakness to paraplegia, FDA data shows. Among the 4,000 types of devices tracked by the FDA, only metal hip replacements and insulin pumps have logged more injury reports.The FDA data contains more than 500 reports of people with spinal-cord stimulators who died, but details are scant, making it difficult to determine if the deaths were related to the stimulator or implant surgery.Medical device manufacturers insist spinal-cord stimulators are safe - some 60,000 are implanted annually - and doctors who specialize in these surgeries say they have helped reduce pain for many of their patients.Most of these devices have been approved by the FDA with little clinical testing, however, and the agency's data shows that spinal-cord stimulators have a disproportionately higher number of injuries compared to hip implants, which are far more plentiful.The AP reported on spinal stimulators as part of a nearly yearlong joint investigation of the global medical devices industry that included NBC, the International Consortium of Investigative Journalists and more than 50 other media partners around the world. Reporters collected and analyzed millions of medical records, recall notices and other product safety warnings, in addition to interviewing doctors, patients, researchers and company whistleblowers.The media partners found that, across all types of medical devices, more than 1.7 million injuries and nearly 83,000 deaths were reported to the FDA over the last decade.The investigation also found that the FDA - considered by other countries to be the gold standard in medical device oversight - puts people at risk by pushing devices through an abbreviated approval process, then responds slowly when it comes to forcing companies to correct sometimes life-threatening products.Devices are rarely pulled from the market, even when major problems emerge. And the FDA does not disclose how many devices are implanted in the U.S. each year - critical information that could be used to calculate success and failure rates.The FDA acknowledges its data has limitations, including mistakes, omissions and under-reporting that can make it difficult to determine whether a device directly caused an injury or death. But it rejects any suggestion of failed oversight."There are over 190,000 different devices on the U.S. market. We approve or clear about a dozen new or modified devices every single business day," Dr. Jeffrey Shuren, the FDA's medical device director said at an industry conference in May. "The few devices that get attention at any time in the press is fewer than the devices we may put on the market in a single business day. That to me doesn't say that the system is failing. It's remarkable that the system is working as it does." In response to reporters' questions, the FDA said last week that it was taking new action to create "a more robust medical device safety net for patients through better data." ''Unfortunately, the FDA cannot always know the full extent of the benefits and risks of a device before it reaches the market," the agency said. In the last 50 years, the medical device industry has revolutionized treatment for some of the deadliest scourges of modern medicine, introducing devices to treat or diagnose heart disease, cancer and diabetes.Pete Corby, who injured his back working as a movie stuntman, said a spinal-cord stimulator helped him deal with his constant pain and stop using the opioids he'd become dependent on."This is the greatest thing that saved my life, literally saved my life," said Corby, estimating that up to three-quarters of his original pain was alleviated by the stimulator.Medical device companies have "invested countless resources - both capital and human - in developing leading-edge compliance programs," said Janet Trunzo, head of technology and regulatory affairs for AdvaMed, the industry's main trade association.At the same time, medical device makers also have spent billions to try to influence regulators, hospitals and doctors.In the U.S., where drug and device manufacturers are required to disclose payments to physicians, the 10 largest medical device companies paid nearly $600 million to doctors or their hospitals last year to cover consulting fees, research and travel and entertainment expenses, according to an AP and ICIJ analysis of data from the Centers for Medicare & Medicaid Services. This figure doesn't include payments from device manufacturers like Johnson & Johnson and Allergan, which also sell other products.On top of that, lobbying records show that the top four spinal-cord stimulator manufacturers have spent more than $22 million combined since 2017 to try to influence legislation benefiting their overall business, which includes other devices.Some companies have been fined for bribing physicians, illegally promoting products for unapproved uses and paying for studies that proclaim the safety and effectiveness of their products, according to the joint investigation.In a 2016 case, Olympus Corp. of the Americas, the largest U.S. distributor of endoscopes and related medical equipment, agreed to pay $623.2 million "to resolve criminal charges and civil claims relating to a scheme to pay kickbacks to doctors and hospitals," according to the U.S. Justice Department. Olympus said that it "agreed to make various improvements to its compliance program." In a case the previous year involving spinal-cord stimulators, Medtronic Inc. agreed to pay $2.8 million to settle Justice Department claims that the company had harmed patients and defrauded federal health care programs by providing physicians "powerful" financial inducements that turned them into "salesmen" for costly procedures. Medtronic denied wrongdoing. "As a matter of policy, Medtronic does not comment on specific litigation," the company said in a statement. "We do stand behind the safety and efficacy of our Spinal Cord Stimulators and the strong benefits this technology provides to patients, many of whom have tried all other therapy options to no benefit." Some doctors enthusiastically promote spinal-cord stimulators without disclosing to patients they've received money from medical device manufacturers. Some experts say doctors are not legally required to disclose such payments, but they have an ethical obligation to do so. Sometimes the money goes to the doctors' hospitals, and not directly to them.As for Taft, he said he just wanted to get better, but he has lost hope."This is my death sentence," Taft said, stretched out beneath his bed's wooden headboard on which he's carved the words "death row." "I'll die here," he said.___ A generation ago, tens of thousands of women were injured by the Dalkon Shield, an intrauterine device that caused life-threatening infections. Consumer advocates demanded testing and pre-market approval of medical devices to prevent deaths and injuries associated with defective products.So in 1976, Congress passed the Medical Device Amendments, a law meant to assure Americans that devices recommended by their doctors would do good and not harm."Until today, the American consumer could not be sure that a medical device used by his physician, his hospital or himself was as safe and effective as it could or should be," President Gerald Ford said when he signed the bill into law.Charged with carrying out the law, the FDA created three classes of medical devices. High-risk products like spinal-cord stimulators are designated to be held to the most rigorous clinical testing standards. But the vast majority of devices go through a less stringent review process that provides an easy path to market for devices deemed "substantially equivalent" to products already approved for use.As designed by Congress, that process should have been phased out. Instead, it became the standard path to market for thousands of devices, including hip replacements implanted in tens of thousands of patients that would later be recalled because metal shavings from the devices made some people sick.The AP found that the FDA has allowed some spinal-cord stimulators to reach the market without new clinical studies, approving them largely based on results from studies of earlier spinal stimulators.Spinal stimulators are complex devices that send electrical currents through wires placed along the spine, using a battery implanted under the skin. An external remote controls the device.The four biggest makers of spinal-cord stimulators are Boston Scientific Corp., based in Marlborough, Massachusetts; Medtronic, with headquarters in Ireland and the U.S.; Nevro, in Redwood City, California; and Illinois-based Abbott, which entered the market after its $23.6 billion purchase of St Jude Medical Inc.St. Jude's application to go to market with its first spinal stimulator contained no original patient data and was based on clinical results from other studies, while Boston Scientific's application for its Precision spinal-cord stimulator was based largely on older data, though it did include a small, original study of 26 patients who were tracked for as little as two weeks.Once approved, medical device companies can use countless supplementary requests to alter their products, even when the changes are substantial.For example, there have been only six new spinal-cord stimulator devices approved since 1984, with 835 supplemental changes to those devices given the go-ahead through the middle of this year, the AP found. Medtronic alone has been granted 394 supplemental changes to its stimulator since 1984, covering everything from altering the sterilization process to updating the design."It's kind of the story of FDA's regulation of devices, where they're just putting stuff on the market," said Diana Zuckerman, president of the National Center for Health Research, who has studied medical devices for nearly 30 years.Medical device manufacturers have cited multiple industry-funded studies showing the effectiveness of spinal-cord stimulation in the treatment of chronic pain. Experts say treatment is considered successful if pain is reduced by at least half, but not every patient experiences that much pain reduction.A 2016 study looking at different stimulation systems found "significant evidence" that they were "a safe, clinical and cost-effective treatment for many chronic pain conditions." But Zuckerman noted that the more extensive studies came after the devices were being widely used on people."These patients are guinea pigs," she said.FDA said in a statement that it approves, clears or grants marketing authorization to an average of 12 devices per business day and its decisions are "based on valid scientific evidence" that the devices are safe and effective.Dr. Walter J. Koroshetz, director at the neurological disorders and stroke division at the National Institutes of Health, said trials for medical devices like spinal-cord stimulators are generally small and industry-sponsored, with a "substantial" placebo effect."I don't know of anyone who is happy with spinal-cord technology as it stands," Koroshetz said. "I think everybody thinks it can be better." ___ Every time Jim Taft walked into his pain management doctor's office, he would glance at the brochures touting spinal-cord stimulators - the ones with pictures of people swimming, biking and fishing.Inside the exam room, Taft said, his doctor told him the device had been successful for his other patients and would improve his quality of life.On lifetime worker's compensation after his right arm was crushed as he was hauling materials for an architectural engineering company, Taft had been seeing the doctor for five years before he decided to get a stimulator in 2014. What finally swayed him, he said, was the doctor's plan to wean him off painkillers."I felt backed into a corner," said, Taft, who lives in West Columbia, South Carolina.Taft said his pain management doctor praised the technology, saying stimulators had improved the quality of life for his patients. But four years later, Taft is unable to walk more than a few steps.Taft is one of 40 patients interviewed by the AP who said they had problems with spinal-cord stimulators. The AP found them through online forums for people with medical devices. Twenty-eight of them said their spinal-cord stimulators not only failed to alleviate pain but left them worse off than before their surgeries.Zuckerman, who has worked at the U.S. Department of Health and Human Services and as a senior policy adviser to then-first lady Hillary Rodham Clinton, said no doctor wants to think they're harming patients."But there's a tremendous financial incentive to downplay, ignore or forget bad patient experiences and just focus on how happy patients are," she said.More than half the patients interviewed by the AP said they felt pressured to get stimulators because they feared their doctors would cut off their pain medications - the only thing helping them.Stimulators are considered a treatment of "last resort" by insurance companies, as well as Medicare and Medicaid. That means doctors must follow a protocol before insurance will pay for the device and implantation.Physicians must show that conservative treatments failed to help, and patients also undergo psychological assessments to evaluate the likelihood of success. They then typically undergo a trial period lasting three days to a week with thin electrodes inserted under the skin. If patients say they got relief from the external transmitter sending electrical pulses to the contacts near their spines, they have surgery to implant a permanent stimulator.Taft said his three-day trial helped reduce his pain so, a few days before his surgery, he began preparing for a new life. He ordered lumber to refurbish a patio and deck for his wife, Renee, as thanks for her years of support.In April 2014, Boston Scientific's Precision stimulator was implanted in Taft by Jason Highsmith, a Charleston, South Carolina, neurosurgeon who has received $181,000 from the company over the past five years in the form of consulting fees and payments for travel and entertainment. A Boston Scientific sales representative was in the operating room - a common practice, the AP found.Highsmith would not comment on the payments. Other doctors have defended the practice, saying they do important work that helps the companies - and ultimately patients - and deserve to be compensated for their time.From the time Taft was cut open and the device placed inside his body, he had nothing but problems, according to hundreds of pages of medical records reviewed by the AP. The device began randomly shocking him, and the battery burned his skin.Taft and his wife complained repeatedly, but said his doctors and a Boston Scientific representative told them that spinal-cord stimulators don't cause the kind of problems he had.That runs counter to Boston Scientific's own literature, which acknowledges that spinal stimulators and the procedures to implant them carry risks, such as the leads moving, overstimulation, paralysis and infections.That also is not reflected in the AP's analysis of FDA injury reports, which found shocking and burning had been reported for all major models of spinal-cord stimulators. For Boston Scientific devices, infection was the most common complaint over the past decade, mentioned in more than 4,000 injury reports.In response to questions, the company called infection "unfortunately a risk in any surgical procedure" that the company works hard to avoid. It added that the FDA's data "shouldn't be interpreted as a causal sign of a challenge with our device. In fact, many examples of reportable infections include those that were caused by the surgical procedure or post-operative care." "In our internal quality assessments, over 95 percent of the injury reports were temporary or reversible in nature," the company added.Taft said had he known the devices hurt so many people, he would have reconsidered getting one. A Boston Scientific sales representative tried reprogramming the device, he said, but nothing worked."I told them that it feels like the lead is moving up and down my spine," Taft said. "They said, 'It can't move.'" But in July 2014, X-rays revealed the lead indeed had moved - two inches on one side.Highsmith told the AP the electrode broke from "vigorous activity," though Taft said that would not have been possible due to his condition. Taft said he was in such bad shape after his surgery that he was never able to redo the patio and deck for his wife or do anything else vigorous.That October, Highsmith said, he operated on Taft to install a new lead, tested the battery and reinserted it.Still, Taft's medical records show that he continued to report numbness, tingling and pain. During a January 2015 appointment, a physician assistant wrote that the device "seemed to make his pain worse." The stimulator was surgically removed in August 2015. The following June, Taft got a second opinion from a clinic that specializes in spinal injuries, which said he had "significant axial and low back pain due to implantation and explantation" of the stimulator.Highsmith said other doctors have documented severe arthritis in Taft and that, while he has not examined Taft in more than three years, it's "likely his current condition is the result of disease progression and other factors." He did not answer questions about whether he informed Taft of the risks associated with stimulators.The doctor said the overwhelming majority of his spinal-cord stimulator patients gain significant pain relief."Unfortunately, in spite of the major medical breakthroughs with devices like these, some patients still suffer from intractable pain," he said.Renee Taft, a paralegal, reached out to Boston Scientific in 2017, but said the company refused to help because her husband's stimulator had been removed and blamed Taft for his problems, also saying he had engaged in "rigorous physical activity" after surgery.In the letter from the company's legal department, Boston Scientific also noted that federal law shielded manufacturers from personal liability claims involving medical devices approved by the FDA.In response to questions from the AP, Boston Scientific again blamed Taft's "activity level" but didn't elaborate. The company also said other factors could contribute to his problems such as "hyperalgesia, a phenomenon associated with long-term opioid use which results in patients becoming increasingly sensitive to some stimuli." Brenda Simpson-Davis of Milton, Florida, said Boston Scientific also disregarded her complaints after her husband suffered a life-threatening infection following implant surgery.George Davis, 57, had three Medtronic spinal-cord implants between 2003 and 2007 after a car accident mangled his back. They temporarily reduced some of his pain, but he said the non-rechargeable batteries that were supposed to last for years never did and he tired of multiple surgical removals.In 2015, his pain management doctor urged him to try Boston Scientific's Precision Spectra, which he called the best on the market. Unlike Davis's old models, it had a rechargeable battery.Within weeks of his surgery, Davis said, he started feeling pain shooting down his back and legs and a burning sensation at the implant site. After his skin started turning black, the doctor performed emergency surgery to remove the device.Months later, Davis reluctantly agreed when his doctor urged him to try another Boston Scientific model but found that device even worse.Over the next year, he spent more than 100 days in and out of hospitals battling a life-threatening infection. Today, Davis says he has trouble getting out of bed.Boston Scientific said it never received the stimulators that were implanted in Taft and Davis so could not "conclusively identify" the causes of their problems. "Numerous factors can contribute to a patient's ongoing symptoms, from increased physical activity to the onset of pain in other areas," the company said.Simpson-Davis said she spoke with attorneys around the country, who warned her about the high bar set for a lawsuit . Finally, she found a Texas lawyer who said he will consider taking the case if she can find another two dozen potential plaintiffs."To me, it's not about the money, It's about the people. It's about them knowing what they're getting themselves into," she said.___ For years, Valerie McJunkin had been seeking relief from a rare neurological disorder that made her legs and feet feel like they were on fire. So when a medical device company sales representative and her West Virginia pain management doctor recommended what sounded to her like a "miracle device," she was all in.They said a new kind of stimulator - one that targeted a bundle of sensory nerve cells in the lower back - was better than a spinal-cord device. She just needed to undergo a weeklong trial.When McJunkin showed up at the pain clinic this January for the trial, the Abbott sales representative was there, along with her doctor and his staff. They explained every detail. This device wasn't for everyone, but she was the perfect candidate, she recalled them saying.Over the next week, they called or texted her nearly every day to see if the stimulator was easing her torment. And since the trial did seem to help, she went ahead with the implant.Within days, though, the device began randomly shocking her - a sharp pain that felt like a lightning bolt.When McJunkin called her doctor and the Abbott representative, she said they suggested that she was at fault because "stimulators don't do that." It wasn't until she received a certified letter from Abbott in March that she learned it wasn't all in her head: The company said her device was being recalled due to a glitch that could cause patients some "discomfort." Since 2005, there have been 50 recalls involving spinal stimulators, averaging about four per year in the last five years. Roughly half the recalls involved stimulators made by Medtronic, the world's largest device manufacturer, though none warned of a risk of serious injury or death.In early September, McJunkin invited an AP reporter to accompany her when she met with her doctor and the company sales representative to request the device be removed.The Abbott salesman and her doctor both suggested she get another stimulator, saying she had run out of options, especially since her doctor couldn't write prescriptions for opioids because of a government crackdown. If she didn't get another stimulator, he said, she faced a lifetime of pain. He did not suggest other options, such as steroid shots or continued physical therapy."I'm not trying to force your mind," the doctor said. "But for me, would I want to live my life like this?... If I get that new battery and it totally helps, that changes my life 180 degrees, right? But if I don't I already know what's going to happen to me: I'll be suffering for the rest of my life." On the drive home to Martinsburg, West Virginia, McJunkin gripped the steering wheel of her car, her tattoo reading "persevere" visible on her forearm."You trust your doctor. You think he's going to do the right thing," she said. She paused, fighting back tears. "I just wanted to live without pain. But now that hope is gone." In late October, her doctor removed the device.The experience of nearly all the 40 patients interviewed by the AP mirrored McJunkin's: Their pain was reduced during the trial but returned once their stimulators were implanted.Experts say the answer may be a placebo effect created when expectations are built up during the trial that only the stimulator can offer relief from pain, exacerbated by patients not wanting to disappoint family members, who often have been serving as their caregivers."If patients know this is a last resort, a last hope, of course they will respond well," said Dr. Michael Gofeld, a Toronto-based anesthesiologist and pain management specialist who has studied and implanted spinal-cord stimulators in both the U.S. and Canada.By the time the trial ends, the patient is "flying high, the endorphin levels are high," Gofeld said.Manufacturer representatives are heavily involved during the entire process. Along with often being in the operating room during surgery in case the physician has questions, they meet with patients to program the devices in the weeks following surgery.Most of the patients interviewed by the AP said the adjustments to their devices were performed by sales representatives, often with no doctor or nurse present. That includes one patient who was billed for programming as if the doctor was in the room, though he was not."People who are selling the device should not be in charge of maintenance," Gofeld said. "It's totally unethical." In a 2015 Texas case, a former Medtronic sales representative filed suit contending she was fired after complaining that the company trained employees to program neurostimulators without physicians present. She also claimed that a Medtronic supervisor snatched surgical gloves away from her when she refused to bandage a patient during a procedure, pushed her aside and then cleaned and dressed the patient's wound. Medtronic denied the allegations, and the case was settled on undisclosed terms.In the Justice Department case involving Medtronic, a salesman who said he earned as much as $600,000 a year selling spinal-cord stimulators claimed sales representatives encouraged physicians to perform unnecessary procedures that drove up the costs for Medicare and other federal health programs."While there have been a few instances where individuals or affiliates did not comply with Medtronic's policies, we acted to remedy the situation in each case once discovered and to correct any misconduct," the company said.Gofeld said he believes stimulators do work, but that many of the problems usually arise when doctors don't choose appropriate candidates. And he thinks the stimulators are used too often in the U.S.Nevro, one of the four big manufacturers, has cited estimates that there are as many as 4,400 facilities in the U.S where spinal-stimulation devices are implanted by a variety of physicians, including neurosurgeons, psychiatrists and pain specialists.It's a lucrative business . Analysts say stimulators and the surgery to implant them costs between $32,000 and $50,000, with the device itself constituting $20,000 to $25,000 of that amount. If surgery is performed in a hospital, the patient usually stays overnight, and the hospital charges a facility fee for obtaining the device. Costs are typically covered by insurance.The AP found that doctors can make more money if they perform the surgery at physician-owned outpatient surgery centers, since the doctor buys the device, marks it up and adds on the facility fee.In Canada, where Gofeld now works, he said the surgeries are done only by those who specialize in the procedures. He said spinal-cord stimulators should be used when pain starts and not after failed back surgeries."By then," he said, "it's too late." ___ While manufacturers and top FDA officials tout stimulators as a weapon in the battle against opioids, neurosurgeons like Steven Falowski are the front-line evangelists."Chronic pain is one of the largest health-care burdens we have in the U.S. It's more than heart disease, cancer and diabetes combined," Falowski said in an interview.He referred AP to Corby, as one of his surgical patients who was helped by a spinal-cord stimulator.Corby got the device more than two years ago and says that, after some initial adjustments, he hasn't had any further problems. He says he wouldn't trade the stimulator for opioids."I was actually buying them on the street ... a little like a druggie because I couldn't get them anymore" from his pain doctor, Corby said.Falowski said opioids are good for acute pain, but were never meant to treat long-term chronic pain. For him, that's where spinal-cord stimulators come in.If they're used early enough for pain, they can prevent people from going on opium-based pain killers, said Falowski, who speaks at neuromodulation conferences and teaches other doctors how to implant stimulators.Since 2013, device manufacturers have paid Falowski - or St. Luke's University Health Network in Fountain Hill, Pennsylvania, where he works - nearly $863,000, including $611,000 from St. Jude or its new parent company, Abbott, according to the Centers for Medicare and Medicaid Services database. The payments range from consulting fees to travel and entertainment expenses.Falowski said he has conducted research and done other work for manufacturers, adding, "The contracts with industry are with my hospital and not with me." St. Luke's told the AP that it keeps the majority of the payments from device makers, but that Falowski "may receive a portion of these payments through his annual compensation." Another of Falowski's patients was Lisa Snyder of Kempton, Pennsylvania, who was searching for relief from a painful nerve disorder. By the time she came to Falowski, she had cycled through three spinal-cord stimulators, which were removed for reasons ranging from infection to rejection."Not everybody could do it, but he was confident he could," she said.After her fourth implant this March, "I complained about this battery right away. I knew it was positioned funny. It burned," Snyder said.AP's analysis showed Abbott products were more likely than other major models to include reports of a hot or burning sensation near the site of the battery, with about 5,600 injury reports since 2008 referring to the words "heat" or "burn." Abbott said that many of the "adverse events" reports in the FDA's data stemmed from a device that was voluntarily recalled in 2011. The company added that feeling a temperature increase at the implant site "is often a reality for rechargeable spinal-cord stimulation systems," which is why the company is now concentrating on devices that do not need to be recharged.Snyder said she felt like Falowski's nurse and physician assistant downplayed the problems and that the reprogramming of her device was conducted by the Abbott sales representative, with no medical staff present. On at least one occasion, she was charged as if the medical staff was there, when she said they weren't, according to insurance bills reviewed by the AP.Despite insisting nothing was wrong with the unit, Snyder said, Falowski called her one day out of the blue. "He said 'Under no circumstances are you to turn it on.' I asked him why and he wouldn't say," Snyder recalled.Falowski then scheduled immediate surgery to remove the stimulator, she said.Falowski called Snyder a difficult patient and said she was receiving "100 percent pain relief" when she had the stimulator removed, adding that she "remained very appreciative of her care." He added that programming is "performed under the direction of a physician." "The physician is not present during the entire programming session, but provides oversight and direction....The only time programming sessions are billed is when the physician is actively seeing the patient during a visit which was the case with this patient," he said.Snyder disputed the doctor's characterization of her and became angry after being told Falowski and his hospital received money from manufacturers."They need to be a little bit upfront," she said.Falowski said doctors do important work for medical device companies, and he has been involved in device development, education, clinical trials and research."You're trying to help patients and you realize as a physician by yourself you're not going to generate $200 million to make the next best implant for a patient and it's going to take a company to do that," he said. "So I think the important part in that relationship is transparency and disclosures." Experts interviewed by the AP said doctors are not legally required to tell their patients about financial relationships with medical device manufacturers, but that it would be the right thing to do."The patient should be fully informed before consenting to a procedure," said Genevieve P. Kanter, an assistant professor at the University of Pennsylvania who specializes in internal medicine, medical ethics and health policy.All Snyder ever wanted was to feel better. Today, she often is immobilized by pain.Before the latest stimulator, she could walk, stand and cook meals. Now, she finds it hard to get out of bed and rarely leaves her house. She says the device has ruined her life."My fear is I'll be like this forever," she said.___ Washington D.C.-based Associated Press reporters Meghan Hoyer and Matthew Perrone contributed to this report, as did Denver-based video journalist P. Solomon Banda.___ Contact AP's investigative team at
2021 09 13
Magbasa pa
Fda Issues Warning About Polymers From Medical Devices; Health Canada in Monitoring Mode
Fda Issues Warning About Polymers From Medical Devices; Health Canada in Monitoring Mode
Hydrophilic polymer embolism the medical name for coating material that separates from medical device surfaces and causes complications.Health Canada and the U.S. Food and Drug Administration are near opposites in their responses to rising evidence of patient harms caused by some medical devices.new B.C. study has added to the mounting evidence about potential complications from the plastic-like coatings on devices such as catheters, guide wires and stents that are inserted through blood vessels during minimally invasive medical procedures.Such devices are coated so they can slide through vessels with less friction and less damage to tissues. But the Vancouver study of 110 patients who died within 90 days of having procedures with coated devices showed that 23 per cent had polymer fragments scattered in different parts of their bodies. Three deaths were judged to be definitively caused by the dislodged material.Hydrophilic polymer embolism is the term used by experts to describe the recently recognized phenomenon in which the foreign material separates from device surface and travels through the bloodstream to various organs in the body.The FDA issued a safety bulletin in 2015 which said there were 500 reports of coating delamination in just two years. There were also 11 device recalls and nine U.S. deaths associated with the peeling or flaking from guide wires used during cardiac angiograms or angioplasties. Last year, the FDA followed up with additional recommendations Health Canada, by contrast, has taken a monitoring position.Eric Morrissette, the department's chief media relations officer, said in an email:"The department reviews data associated with the delamination of coatings to ensure that such devices do not shed material. In addition, the labelling of these devices sold in Canada must contain warnings to inspect the devices for any signs of damage (kinked or weakened segments, or delamination of coatings)."Health Canada's position is that the benefits of these products continue to outweigh the risks. This balancing of benefits and risks is a key part of any assessment for a medical device or drug in Canada." The Canadian agency is aware of the FDA notices, Morrissette said, but has not issued its own."Should new evidence come to light related to the safety of these devices, Health Canada will take appropriate action," he said.Devices inserted through blood vessels for so-called endovascular procedures in B.C. include those made by companies like Bard, Cook, Boston Scientific, Gore and Canadian Hospital Specialties. Some m anufacturers were repeatedly contacted by Postmedia for responses to the latest study. All declined to comment.Dr. Dave Wood, a Vancouver interventional cardiologist and d irector of the Vancouver General Hospital cardiac catheterization laboratory, said the study "absolutely" poses some "intriguing hypotheses" that need further investigation."To be truthful, it wasn't on my radar. But it is now. And I'm not trying to belittle the study, but we have clinical trial data on these devices showing they are generally safe and effective." Wood said he's not aware of any occasion when coatings have come off devices he's used. Patients undergoing endovascular procedures are cautioned about the small risk of heart attacks and strokes after such procedures. The fact that coating debris has been found to have caused three deaths is not going to change the general information he gives patients during the informed consent process although he acknowledged patients may now ask about it because of news coverage.Dr. John Maguire, a VGH neuropathologist.Arlen Redekop PNG He said he's anxious to collaborate on further research and has already reached out to the study leader Dr. John Maguire, a neuropathologist.In 2017, Dr. Rashi Mehta and Dr. Rupal Mehta, U.S. experts, gave an update for physicians about the significant complications that can ensue from device delamination.This week, Rupal Mehta said there has been enormous pushback from physicians and medical device industry personnel who insist complications are too rare to worry about.Dr. Harry Vinters, a professor and anatomical pathologist at Ronald Reagan UCLA Medical Center who has collaborated on research into the coating problem, praised the Vancouver researchers."Their study is especially intriguing in that it utilizes what could be considered old technology - careful tissue analysis of autopsy specimens - to derive extremely important new information that has a direct impact on outcomes in a select group of patients. Indeed, the autopsy is about the only way this data could have been derived, and Dr. Maguire and his colleagues are to be congratulated for the care with which the study was performed and the data analyzed." Vinters said despite the latest research, it is still impossible to quantify the degree of risk."Autopsy studies are not population-based studies, they look at highly selected individuals." Asked if interventional cardiologists and other specialists using such devices should give patients specific information about such risks during the informed consent process, he said:"Generally, consents given by both anesthesiologists and surgeons are all-encompassing and include warnings about possible negative outcomes." Christopher Thrall, spokesman for the Canadian Patient Safety Institute, said studies like the one in Vancouver are important and while the agency doesn't have any statistics on delaminations on device coatings, Canadian patients are generally vulnerable to adverse events in the hospital because of such things as faulty devices, medications, mistakes and falls. For instance:• Every 17 minutes someone dies in a Canadian hospital from complication of treatment. That's about 31,000 people a year.• There are hundreds of thousands of preventable patient safety incidents each year. One out of 18 hospital visits results in preventable harm.• Over 40 per cent of complex surgical patients suffer harm. Patients who suffer harm are four times more likely to die in hospital than those who don't.Thrall said the Institute for Safe Medication Practices Canada Health Standards Organization , and the Canadian Patient Safety Institute are working together to support a Health Canada initiative that requires health care institutions to identify and report on serious adverse drug reactions and medical device incidents.Twitter:@MedicineMatters
2021 09 13
Magbasa pa
U.S. Regulators Snip Red Tape for Medical Devices to Curb Opioid Crisis
U.S. Regulators Snip Red Tape for Medical Devices to Curb Opioid Crisis
(Reuters) - Laura Perryman expected her medical company, Stimwave Technologies Inc, would have to wait several years for its painkilling device to win U.S. approval as a treatment for chronic migraines.She now thinks it could be done in months, thanks to a new initiative by the U.S. Food and Drug Administration to use medical device-based treatments, diagnostic tests and mobile medical apps to address the country's opioid crisis.When President Donald Trump declared a public health emergency over the abuse of heavy-duty painkillers like oxycodone and hydrocodone, he ordered all government agencies to take action in response to the death of 70,000 Americans last year from drug overdoses.The FDA told Reuters it has received over 200 submissions from companies seeking a speedy approval process for their devices. These range from Stimwave's Halo to painkilling products made by Abbott Laboratories and other industry heavyweights as an alternative to opioids."We're pleased by the robust interest in this innovation challenge and the acknowledgement from developers about the unique and important role medical devices, including digital health technologies like mobile medical apps, have the potential to play in tackling the opioid crisis," FDA Commissioner Scott Gottlieb said.Perryman's Halo devices, which look like angel hair pasta and are so small they can be injected into a nerve, took four years to get U.S. approval under other names for easing leg and back pain.She hopes a spot on the FDA program will see Halo approved within a year as an alternative to opioids, which are currently used to treat an estimated 50 percent of patients who come to emergency rooms with migraines."This is kind of perfect for something like ours...since the device is shown to be safe already," said Perryman, who founded privately-held Stimwave in South Florida seven years ago.The FDA has been increasingly reluctant to greenlight new opioids for market but earlier this month approved a potent opioid-based painkiller from AcelRx Pharmaceuticals Inc placing tight restrictions on its distribution and use. In a rare move, Gottlieb made a public statement at the time, explaining the decision.The regulator's push for alternatives to opioids has helped drive interest from venture capital funds and institutional investors this year in firms promising to develop alternatives, according to interviews with device companies, financial services firms and brokerage Cowen & Co.For example, privately-held Virpax Pharmaceuticals, which makes an aerosol spray that delivers a non-opioid pain drug, said it had four or five banks interested in running its Series A investment round this summer versus just one in the past.Abbott, like rivals Boston Scientific Corp and Nevro Corp, makes neuromodulation implants which stimulate the nervous system to mask pain signals before they reach the brain.Abbott has submitted an entry for the competition in the hope it will slash waiting times, which often stretch several months just to get an initial meeting, according to Dr. Allen Burton, Abbott's medical director of neuromodulation."Devices that are part of this (program) will be streamlined... their meeting will go to the top of the pile," said Burton.While neuromodulation is only a small part of Abbott's large medical device business, the unit is seen as a growth engine for the company. Burton estimates between 10-to-20 percent of the growth Abbott has seen in its neuromodulation business could be tied to doctors prescribing its devices for pain after surgery or from injury to patients that are opioid averse.Boston Scientific did not apply for the contest, but the company is investing "heavily" in its neuromodulation unit, which was its fastest-growing at nearly 23 percent in the latest quarter, according to Maulik Nanavaty, senior vice president at the device maker."We continue to make external investments in early (neuromodulation) technology," he told Reuters.To be sure, these devices are not seen as a silver bullet for opioid addiction. Nirad Jain, a partner at consulting firm Bain & Co, believes many of the solutions on the table are just tinkering at the edges of a problem that needs to be solved by doctors simply settling for fewer or less potent opioids.Academics and charitable groups dealing with the social fallout of the crisis say the bulk of the rise in deaths stems from misuse of prescription painkillers. That has put the onus on regulators in September to issue new rules cracking down on prescribing by doctors."The goal is that these guidelines will provide evidence-based information on the proper number of opioid doses that should be dispensed," Gottlieb said in a statement at the time."Our goal is to help prevent patients from becoming addicted by decreasing unnecessary or inappropriate exposure to opioids." Although the FDA contest is limited to devices and app-based solutions for pain and addiction, the current regulatory climate is also conducive to companies developing opioid-alternative pharmaceuticals.Drugmakers including Pfizer Inc, Eli Lilly and Co, Regeneron Pharmaceuticals Inc and Teva Pharmaceutical Industries Inc have been packing their pipelines with potential solutions to the crisis and there are 120 non-opioid drugs under FDA review this year, up some 650 percent since 2013, according to business intelligence firm Informa.(Non-opioid drug applications surge png, tmsnrt.rs/2ReUI2H Privately-held SPR Therapeutics Inc told Reuters it has entered its "temporary" neuromodulation device in the contest. Similarly to Stimwave's, its product is implanted into the body but can be surgically removed after about two months. Josh Boggs, a senior executive at the company, expects to get quicker feedback from the FDA and shorter review times in the wake of the crisis.After years in the business, he believes the crisis has increased the agency's desire to collaborate with medical technology companies like his."I feel like (FDA) people are coming well prepared to meetings and are very engaged in it. It feels like an atmosphere that's conducive to finding a solution," he said.(The story corrects third paragraph to say the deaths were from drug overdoses, not specifically opioid overdoses)
2021 09 13
Magbasa pa
Fda Approval of Medical Devices Involves Shockingly Little Research
Fda Approval of Medical Devices Involves Shockingly Little Research
Are federal regulators playing fast and loose with the health of the tens of millions of Americans who rely on medical devices to see, walk and survive?That's the suggestion of a new study that finds most medical devices go to market with little evidence that they work or are safe.Groups like Consumer Reports and the Government Accountability Office have long criticized the U.S. Food and Drug Administration for approving medical devices that end up killing thousands of people a year . They've been most critical of the fact that the FDA allows 99 percent of new devices to go to market without any new clinical testing whatsoever.But a team at the Yale School of Medicine found that even the 1 percent of devices that are studied before getting FDA approval likely aren't being studied enough.This 1 percent consists of so-called "high-risk" devices, which are very different from any others on the market and which are implanted within the body or directly support human life. The Yale researchers found that these devices are subjected to an average of just one major study apiece before being granted FDA approval. This means that doctors are implanting devices like coronary stents, replacement hips and intraocular lenses in thousands of patients after they've been tested on groups of just a couple hundred people each.Dr. Joseph Ross, a professor at Yale School of Medicine and one of the authors of the paper, said that this state of affairs is the result of federal legislation stipulating that the FDA can only require manufacturers to do the bare minimum amount of research to demonstrate the efficacy and safety of a new medical device."The laws are written in a way to facilitate earlier access to therapy, because that's what most lawmakers think their constituents want," Ross said. "But as a result, we don't have the data we need to make the best decisions for our patients." For their study, Ross and his co-authors looked at the 28 high-risk devices approved by the FDA in 2010 and 2011. They found that, on average, each device was the subject of just two studies before getting FDA approval, and that in most cases, one of the two studies wasfocused more on the basic mechanics of the device than on its long-term clinical effects.As a condition of its approval, the FDA did stipulate that manufacturers would have to carry out further studies of the effects of these devices after their release. The FDA called for 33 such studies in all, among the 28 devices approved in that period -- a little more than one additional study per device. But the research team found that just six of these 33 studies have been completed so far, five years after some of the devices were released. Moreover, many of the clinical trials that have been completed failed to compare the medical device in question with any other medical device.Though none of the 28 devices have been implicated in the death of any patients, one of them -- a stent used in the treatment of brain aneurysms -- was voluntarily recalled because of a flaw that the FDA said could have been deadly . And more than 6,000 of the 150,000 patients who have been implanted with another device, DePuy's Pinnacle Complete prosthetic hip system, have sued the manufacturer , claiming that the metal-on-metal device caused pain and leached harmful metal ions into their bloodstreams.Ross said that there are no protocols in place to identify patients using any given medical device, so it's impossible to say exactly how many of a particular device are currently being used, or to monitor their impact in a rigorous way."Right now, medical devices, unlike your computer, or your television, or even a box of pens you would buy -- they don't have a bar code on them," he said. "So we can't track devices once they leave the manufacturer." This, at least, is changing. A law mandating identification numbers for all medical devices will be phased into effect starting in 2016 But Ross warned that the 21st Century Cures Act, a major scientific research bill passed overwhelmingly by the House of Representatives last month and currently under consideration by the Senate,could make the FDA's already low threshold for approval of new medical devices even lower."There are a lot of measures aimed at FDA deregulation in the bill," Ross said. "It's minimizing their ability to impose stricter evidentiary standards prior to approval for lots of products, including medical devices." UPDATE:8/18, 6:20 p.m. -- In an email to The Huffington Post Tuesday, the FDA noted that "some FDA mandated post-approval studies are longer than the three to five year observation period in the study," and that "therefore the studies may not be expected to be completed." The agency also noted that it "uses a variety of other data sources and methods to monitor the safety and effectiveness of marketed medical devices." "These can include medical device reports (MDRs) of adverse events and product problems, device registries, review of scientific literature, and other approaches depending on the specific device and public health need," the FDA said in its email.If you or someone you know has suffered adverse consequences as a result of a high-risk medical device, The Huffington Post wants to know. Please contact the author of this story at .
2021 09 13
Magbasa pa
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