05292017Headline:

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Does the FDA Know Your Medical Device ID?

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The Food and Drug Administration (FDA) tracks prescription drugs using a medicine’s unique code. Some devices that are implanted in patients have identification numbers also, such as heart pacemakers, for instance. And that is very good, because if a particular pacemaker type or model number is found to be defective, such as one type of Guidant pacemaker in the recent past, there may be a news release and accompanying recall notice identifying the model number. Thus, the patient with the defective device can request his or her device be replaced. But some devices do not have part or model numbers per se, the FDA is unable to track how many of which devices are implanted in patients to-date.

In addition, according to Lena Groeger’s May 8 article on MNBC.com, one regulatory law expert William Vodra, a member of the Institute of Medicine panel that published a report on medical device safety[1], says there is little direct communication between physicians and surgeons who implant devices and the manufacturers. Physicians and surgeons either don’t have the time or the inclination to contact the manufacturers of the devices they implant.

It gets down to the nitty-gritty, however, when a physician or surgeon becomes aware of potential harm which may have been done to a patient due to the implantation of a particular device! And then the blame game begins, manufacturers may blame suppliers and vice versa, recall notices are issued, companies are purchased, products are removed from the shelves, new products are manufactured by new companies replacing the defective ones and… obfuscation is the problem. What happened to Guidant following the disclosure of defective pacemakers is a fair example. Guidant no longer exists.

The FDA reminds us that “every medical device carries a potential risk,” and “the vast majority of devices perform well and improve patient health.”[2] But we cannot forget that there have been many implanted devices which do not improve a patient’s health, but have ruined it. Some argue that it isn’t the device, but the surgery. Whatever the case, in this era of technology wonders, we should be able to track devices which are implanted, from intra-ocular implants to hip joints—and document those that work and those that are deleterious to the host.

It has been “more than five years since Congress ordered the FDA to devise a post-market surveillance system to track the safety of all medical projects,”[3] but it has not done this for medical devices—because it does not have the data. While the FDA acknowledges that an identification system for devices is needed and it has a Congressional mandate to produce one, the unique device identification (UDI) system does not yet exist. And we wonder why? As more instances of device failure, such as the Riata defibrillator lead controversy, continue to occur, perhaps the FDA will find a way to implement a tracking system, which may prevent more harm to recipients.


[1] “How Does the FDA Monitor Your Medical Implants? It Doesn’t, Really”, Groeger, Lean, ProPublica, MSNBC.com, May 8, 2012. http://vitals.msnbc.msn.com/_news/2012/05/03/11524103-how-does-the-fda-monitor-your-medical-implants-it-doesnt-really

[2] Op.Cit.

[3] Ibid.