William Hyman: Early (or Late) Warning with Medical Device Problems

Recalls typically are based on a conclusion reached by the manufacturer that there is a problem with a device that can lead to, for a Class I recall, serious adverse health consequences or death. For Class II and III recalls, the risk is proportionally lower. The recognition of a problem often begins with an increase in complaints. Note here that the starting point may not be zero complaints. There may be a steady rate of complaints which the manufacturer finds acceptable. This acceptable rate is not transparent to users and patients, nor is there a determination that it is acceptable to them.

Of importance from a safety perspective is the timeline over which a manufacturer becomes aware of a problem and then decides to undertake a recall. During the period from awareness to recall, additional users and patients are put at risk for the hazards created by the device that were ultimately deemed to make a recall necessary. People who are victimized by a recalled product close in time to the ultimate recall might be particularly aggrieved, especially if it appears that the manufacturer moved without appropriate deliberateness. Sometimes, delays may be associated with determining that there really is a device problem. Other times, delays may be more of a business decision driven by concerns for reputation, lost sales or market share, and product inventory that would have to be scraped. Delays also might be based on waiting until a fix is available. However, a fix is clearly not required for a recall and withholding information about the need for a fix is not in the user/patient interest. In rare occasions, removing a product might create issues of availability, but this would only occur if the product was capital equipment and hard to quickly replace, or if the device was unique. Even here, open and timely communication would allow the customer to decide whether to use the product, rather than this decision being in control only of the manufacturer.

The time-to-recall problem requires a three-pronged solution: moving rapidly, communicating early upon recognition of a problem, and not letting business considerations overwhelm patient safety decisions.

The FDA has recently addressed this problem in a draft guidance document called Public Notification of Emerging Postmarket Medical Device Signals. This draft notes that early signals of a problem may identify a potential impact on patient management decisions and/or alter the known benefit-risk profile of a device even when there has not yet been full validation or confirmation. Earlier communication about emerging signals would likely provide healthcare providers, patients, and consumers with access to evolving information that might influence treatment choices. This approach also might reduce the number of patients exposed to the potential risk while the issue is being evaluated. These early communications may lead to or influence an official “safety communication” or other action, although such communications themselves are often at least somewhat relevant to other action, if there ever is other action. The FDA draft does not address early communications from manufacturers.

Currently, we depend on manufacturers, and secondarily the FDA, to assess indications of device problems and to act on those assessments in a forthright and timely—if not rapid—manner. Such action can protect patients during the period between early indications of a problem and a recall or discontinuance of the device. For now, sometimes this happens—and sometimes it doesn’t.

William Hyman, ScD, is professor emeritus of biomedical engineering at Texas A&M University. He now lives in New York where he is adjunct professor of biomedical engineering at The Cooper Union.

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2 Comments on “William Hyman: Early (or Late) Warning with Medical Device Problems”

  1. James Beck Says:

    I don’t understand how the FDA not even notifying device manufacturers about such communications helps advance the ball here, since the manufacturers are ultimately responsible for any corrective action. We end up with a situation where the “evidence,” if it can be called that, is insufficient for the manufacturer to change its warnings under FDA CBE standards, yet the FDA is nonetheless notifying the public about some hypothetical risk that might or might not exist. There’s not much a manufacturer is legally able to do in that situation, since the FDA is, by definition, acting on something that the manufacturer’s on ongoing algorithms have not picked up.

    The real solution is Sentinel and moving away from voluntary adverse reaction reporting and moving to big data.


  2. J Scot Mackeil CBET Says:

    Reading this column, I remember back when I ran a one-man biomed shop for a community hospital. From time to time, I submitted product complaints to the FDA and MedSun that resulted in an OEM doing a corrective action on at least two occasions I know of. I worked closely with risk management on SMDA complaints and the annual reports. Then, as time and management practices changed there, a third-party biomed service group took over biomed operations as “cost-savings measure.” I remember the risk manager telling me, “Since [company X] took over, I have not had one report to file with the FDA in the last couple years. Why is that?” I told her that the fact that FDA SMDA, and MedSun reports were drying up is one of the casualties of having a subcontractor provide biomed services. Third-party staff are not invested in the hospital in the same way as direct biomed employees. The reports are time consuming and difficult to file correctly. Also, managers from third-party companies are far less likely to see such reporting as a positive and more as a negative because it may be looked on as black mark against future contract renewals. Moving forward, I now work in a large academic medical center and there are too many layers of bureaucracy to negotiate to make all but the most serious observed problems possible to report. As a tech who works at the bedside and who deals with this equipment every day, I would indeed like to have a better way to generate these so-called “medical device signals” for the betterment and enhancement of patient safety in the real-world setting. I would love to have an app on my smartphone that lets me take a photo and fill out a report to MedSun at the point of contact with the device in question. The last time I tried to fill out a MedSun report, just finding the report form online was a major mission. Then the PDF form didn’t run smoothly, etc. I finally gave up. To take both these concerns off the table and allow us to be the sentinels we should be, our industry needs a better, easier to use smartphone-based, sentinel system (MedSun) for medical device failures and defect reporting. Such an app is on my wish list of things I would like HTM leaders to cook up for us guys out here working in the trenches. Any one out there care to rise to the challenge and make it happen?


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