Sometimes, there can be a gap between safety efforts and the actual achievement of measurable safety. That may arise because official safety efforts are not addressing real problems, the safety efforts are not effective, or the safety-related procedures or other improvements are not actually followed. In this regard, safety-related pronouncements and “sloganeering” can easily become activities that lack a real value.
All safety activities should be able to demonstrate that they actually enhance safety. Such demonstrations require pre- and post-intervention data. Unfortunately, “pre” is often not available and “post” is often not adequately obtained. The FDA’s recent Medical Device Safety Action Plan contains at least some elements that I consider a falling into a “safety platitude” category. That is, asserting the value of activities without proof that they work.
The FDA plan in part addresses a subset of activities already undertaken. These include establishing unique device identifiers (UDIs), developing the National Evaluation System for Health Technology (NEST), and creating a competitive marketplace for device quality.
As I wrote in April, I believe it is fair to say that UDI has not yet fulfilled its promise. While it might have the potential for doing some of the things claimed for it, that potential has not been realized. For example, I’ve heard it said that UDI helps the recall process. However, I am not aware of a recall that has provided UDI numbers, although one could use the recall information to look up the UDIs. UDIs also have not yet been widely included in medical records, so you cannot use the UDI to find the affected patients. One recent implant recall advised physicians to call the manufacturer to get patient information, presumably based on a patient/device registration system.
NEST is largely unknown, although the basis for it can be traced back to 2012. NEST has had its contracted coordinator since August 2016. The FDA’s 2017–2018 strategic priority report cites a six-year investment to lay the foundation for the creation of NEST. That is quite a foundation. Like many initiatives, NEST has grandiose goals, including to “generate evidence across the total product lifecycle of medical devices by strategically and systematically leveraging real-world evidence and applying advanced analytics to data tailored to the unique data needs and innovation cycles of medical devices.” A patient-focused NEST workshop is scheduled for Sept. 12, 2018.
With respect to the competitive marketplace for device quality, the FDA makes the interesting assertion that the marketplace often does not provide strong incentives to manufacturers to make an established device safer in the absence of a new or greater-than-previously-understood safety concern. This in part blames customers for safety hazards in the devices they have already purchased by suggesting that they won’t buy new and better ones. However, the disincentive might also be internal to the manufacturers with respect to admitting that their current product has dangerous faults at a below-recall level.
One of the ways the FDA says this market issue might be addressed is to streamline regulatory controls on safety enhanced devices. To do this, the FDA plans to “pilot the use of a progressive maturity model appraisal approach to evaluate participants’ organizational excellence, identify any gaps, and recognize when a participant performs above a compliance baseline.” This seems to suggest that manufacturers could be rated on their excellence, and that in turn there might be, for example, “A-rated” companies, “B-rated” companies, etc. Whether these ratings would be public is not clear. This approach can be seen in the current pilot for the Digital Health Software Precertification (Pre-Cert) Program. One consequence of this approach is that established companies might increase their advantage over startups because it might be difficult for a newcomer to show how excellent they are.
Pronouncements of new initiatives—and how “wonderful” they will be—remind me of something I learned in academia: New initiatives are always infinitely more exciting, more promising, and deserving of more support than existing activities, no matter how important the existing activities are and what resources they need to continue to be important. New initiatives also have the advantage of being heavy on promise yet too new to have proved their proposed merit.
At the risk of being charged with being against progress, I do accept that real progress is desirable. But we have to also consider that just doing something new and different doesn’t make it progress.
William Hyman, ScD, is an adjunct professor of biomedical engineering at The Cooper Union and a consultant in New York. He is also a professor emeritus of biomedical engineering at Texas A&M University.