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Nicole Greer
Nicole Greer
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Medical Devices – Time For More Oversight, Not Less

4 comments

Do you use a medical device? You probably do, even if you don’t know it. If you have been harmed by a medical device, you may have a legal claim.

Do you wear contact lenses? CooperVision AVAIRA Toric Soft Contact Lenses were just subject to a Class I recall, which is the most serious type of recall, meaning there is a reasonable probability that use of the product will cause serious adverse health consequences or death. The contact lenses were recalled because of a silicone oil residue on the lenses which can cause blurry vision, discomfort, or serious injury requiring medical treatment and jeopardizing vision.

Have you had orthopedic surgery? There is an ongoing safety review of arthroscopic shavers that are used in some orthopedic surgeries, because pieces of tissue, not evident to the naked eye, are remaining in the shavers even after cleaning which can compromise the entire sterilization process.

Those are just a couple of examples of medical devices that have been subject to a recent recall or safety communication.

Medical devices include virtually everything you might come in contact with in a healthcare setting other than drugs. Medical devices include instruments, machines, implants, and other similar items that are not drugs, which are used for the diagnosis or treatment of a disease or medical condition. Medical devices can include things as complicated as an artificial heart or as simple as tongue depressors, as well as a wide variety of devices in between, such as catheters or infusion pumps.

Prior to a company marketing a medical device, it must be cleared or approved by the FDA. A new medical device can receive “approval” if the FDA finds that the applicant has provided reasonable assurance of the device’s safety and effectiveness. This is the most stringent standard applied by the FDA with regard to the marketing of medical devices, but it has weaknesses because it relies on the accuracy of the information provided to the FDA by the company that wants to sell the device. Alternatively, a medical device can receive “clearance” if the applicant shows that the device is “substantially equivalent” to another device that is already legally marketed for the same use, although the devices do not have to be identical.

In theory, receiving clearance from the FDA to market a medical device that is substantially equivalent to another device that has already received approval would seem to make it possible for consumers to have access to safe medical devices sooner. However, the medical device you trust is safe may have only received a superficial clearance based on the manufacturer’s representation of substantial equivalence.

As each new medical device deviates slightly from the one before it, but is still deemed “substantially equivalent,” decades can pass between the time the original device was approved and the time the medical device you use receives clearance. That means your medical device may bear very little similarity to the original medical device that was approved pursuant to a more stringent review for safety and effectiveness years earlier.

Just because a medical device received approval or clearance from the FDA does not necessarily mean it is safe. The FDA posts information on an ongoing basis about medical devices that are subject to recalls and safety communications as adverse events are reported by patients, physicians, and medical device manufacturers. Some of the problems encountered with medical devices are minor, but some can lead to serious injury or even death.

Rather than trying to protect patients who have to trust that the medical devices they use are safe, the United States House of Representatives Energy and Commerce Committee is supporting legislation that would make it easier for medical devices to receive clearance. The Committee says it is worried about the delay in getting medical devices to patients while they undergo review by the FDA. But wouldn’t you prefer for the FDA to thoroughly evaluate the safety and effectiveness of a medical device rather than allow you to use it, only to find out later that it wasn’t safe? Do you want to be the test patient without giving your consent?

The Committee says that the current FDA process for approval and clearance of medical devices is causing manufacturers to move overseas where there may be less oversight, supposedly resulting in the loss of jobs to Americans and making it so that medical devices are available in other countries but not in the United States. Even if that is true, is that so bad? One of the great things about living in the United States is that this country cares about the safety of its citizens in a way that many other countries do not. Do you really want to use a medical device that is manufactured by a company that is trying to avoid FDA review of its safety and effectiveness?

If you were injured by a defective medical device, you can check the FDA website to see if it was subject to a recall or safety communication, and you should discuss your injury with an attorney as soon as possible to determine whether there is a legal claim you can pursue.

4 Comments

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  1. Martin Berardi says:
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    This is a ridiculously slanted article that has been put forward without enough factual research. While I find the FDA to be steeped in old fashion ideals , they do tend to be careful to a fault.The PMA or 510(k) process for FDA Interstate Commerce authorization comes up short in a few areas but still provides a reasonable way to bring safe and effective devices to the healthcare industry. I would ask for some additional proof from these legal experts about the scare tactic of how a device may be using marginally equivilent predicates in their claims to the FDA. I have to believe there has been some drift, be show me the substantial proof that this is something to be concerned about.
    Looking at the data …one of the things that the FDA could be considering is how the EU uses a firms CE mark on a medical device to maintain the ability to market that device to patients in Europe. It is the certification of the facilty and their procedures that allow them to self-certify the CE mark and provide the product to healthcare. I believe the data shows that this process yields similar safety as the current FDA process and is more in tune with getting better devices to market faster for the good of helthcare in general …. that is why many Companies are opting to go through the CE mark first ….its not a safety issue.
    This again is a woefully slanted piece and could use some real data vs a scare tactic approach

  2. up arrow

    Martin Berardi,

    It seems like you missed the point. The author clearly explained how the process works–the FDA relies on the company’s own representations. Do you disagree that this is how the process works?

    I find it interesting that you ask for “substantial evidence,” then proceed to make unsupported claims about how you “have to believe” the process works as is. The evidence was in the recalls listed–something that might be of legitimate concern.

    The author suggests that, in her opinion, consumers would be better off with more oversight, not less, and not relying merely on the manufacturer’s representations. Where are the scare tactics?

  3. FaithfulServant says:
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    >Although initially it was thought that polydimethylsiloxane (silicone) was biologically inert, recent published studies have demonstrated varying levels of IgG antibody reactive with this structure in humans.

    >Because silastic material is one of the most commonly used biomaterials in modern medicine, the biocompatibility of these implants is still a source of long standing controversy. Though several studies have established silastic material as biologically inert, numerous authors have repeatedly described characteristic pathological tissue responses to silicone and its elastomeres. We report a case of foreign-body reaction to silastic burr-hole cover with successive formation of a seroma following resection of an olfactory groove meningioma. Within 30 days postoperatively, the patient developed a marked bulge in the glabbelar region. Histopathological examination revealed a seroma-like lesion obviously caused by a chronic inflammatory allergic reaction to the silastic burr-hole cover. Although the silicone-induced tissue damage clinically shows a wide variability and a conclusive model of pathogenesis is presently not available, the histopathological findings in some patients, in the form of granulomatous lesions and inflammatory cell response, might partly be due to an immunological reaction. Such a reaction has been previously described both clinically and experimentally, as detected in our patient. In addition, a review of the literature is given.

    THIS IS WHAT DOW KNEW

    http://www.webstarmagic.com/smoke_fire/documents_1-50.htm

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    Medical device companies (classes II and III) also need to keep a clean database of those who buy their products so they can communicate recall and related information.

    This is sometimes easier said than done, especially when medical devices are sold through distribution.

    One workaround is the tried-and-true warranty card. The updated version of this is online registry with perhaps a sweepstakes entry for each compliant customer.

    For marketing communication, lead generation, customer information capture, and social media, you can reach me at http://MedicalMarcom.com.

    Thanks for the informative article.

    Joe Hage