Why mobile health devices need FDA oversight

Everyone has heard of a recall of a consumer product such as a component of an automobile, child’s toy, or an over the counter medication.  A recall of those types of products often implies taking them off the market as well as replacement or repair (in the case of device or car components).

During my 20 years as a practicing cardiac electrophysiologist, I witnessed firsthand the evolution of how implanted medical device ‘recalls’ are viewed and dealt with by industry, the FDA, lawyers, physicians, and patients.  Specifically, I experienced a few major ‘recalls’ of implantable cardioverter defibrillators (ICDs) and pacemakers.  The companies at that time left it up to physicians to inform patients.  Unfortunately, the public found out from mass media before physicians were even informed by the device manufacturers. Physicians received little in the way of guidelines from either companies or the FDA with regards to managing affected patients.

Today, much is different.  There are both professional and FDA guidelines on how physicians approach many recalls.  We have learned both to create registries of affected patients and to use remote patient monitoring to more rapidly and completely identify the problem at hand. The word recall is not appropriate in most circumstances, and the term advisory is used.  This is because most advisories do not necessitate the removal of the device or component.  It unnecessarily makes the issue a black and white one, conjuring up a lone solution consisting of device replacement.  In fact, most advisories are today solved with device software reprogramming.  There is currently an ICD advisory which has evolved into a public relations battle being fought in the mass media. I believe that advisories, like the manufacturing of the device itself, should focus on the patients themselves. The sensationalism only decreases confidence in the entire industry and might result in fewer people choosing to avail themselves of lifesaving technology, creating potentially more harm than that done by the recalled product.

So how does this tie in to digital health technologies? Firstly, it must be said that advisories or recalls affect an extremely small segment of most devices. Device advisories and recalls will occur with mHealth technologies as well.  These devices are not 100% immune to defects.  Most defects when they do occur, affect components which are not critical. Some will affect direct to consumer types of devices, which would translate into a voucher for refund or replacement. Others, however, will be of a potentially more significant nature, possibly affecting the accuracy of remote patient monitoring data (though in over 12 years of remote patient monitoring of ICDs no significant defects have been seen regarding the monitoring capabilities itself) or technical glitches possibly resulting in wrong advice being given.

It is when we get into the more sci-fi types of technologies where defects may affect patients more.  Implantable monitors, drug or DNA transporters or monitors injected into the bloodstream, or artificial type skin with sensors, where an advisory or recall approaches new territory.  The FDA is moving to tighten post-market surveillance of implantable devices, in part with the institution of a unique device identifier (UDI) system. I believe that mHealth products will be able to be tracked much easier than by UDIs by virtue of their own technologies’ tools.  Quality control of mHealth should not be any different from other medical devices, and should therefore fall under the auspices of the FDA.

David Lee Scher is a former cardiologist and a consultant at DLS Healthcare Consulting, LLC.  He blogs at his self-titled site, David Lee Scher, MD.

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