In July 2013 and October 2013, I addressed the U.S. Food and Drug Administration’s progress in completing the various elements of improvements to its postmarket surveillance program. This effort has 14 parts divided among three deadlines: June 2013 (five parts), September 2013 (six parts), and December 2013 (three parts). As of October I counted two—or four, if one agrees with the FDA’s assessment—of these parts completed. The uncertainty arose from the FDA, in my view, taking credit for completing some parts when the cited achievements didn’t seem to quite meet the stated goals.
The FDA posts its own scorecard for its planned improvements. As of a Nov. 25, 2013 update, the FDA claims completion of five of the 14 parts. They are:
- Finalize the unique device identification (UDI) rule.
- Develop the UDI database.
- Provide the Office of the National Coordinator for Health Information Technology (ONC) with UDI technical requirements for electronic health records (EHRs).
- Complete a think-tank report on UDI.
- Implement a mobile app for medical device reporting.
Of these, the UDI database accomplishment seems a bit premature since it is still the subject of draft guidance and, as the FDA notes, “The public GUDID search function is temporarily disabled until a meaningful data set of DI records has been created.” The “completion” of the think-tank report points to some workshop events—but not a final report—that occurred before the postmarket surveillance program plan was even posted. Perhaps proposing to do what you have already done is a better strategy than proposing to do what never gets done. The mobile reporting app is an adaptation of a previously existing Boston Children’s Hospital voluntary reporting tool that in my opinion can be fairly described as not quite useful.
Of the nine parts remaining by the FDA’s accounting, one remains from June, five from September and three were targeted for Dec. 30, 2013. One of the June items was the establishment of a medical device registries task force and from September is the establishment of a national medical device postmarket surveillance system planning board. A call for nominations for both of these activities was issued on Dec. 18. If we then generously count these as completed, that leaves four from September and three from December, with the acknowledgment that the government shutdown may have produced some extra delay.
Since I have previously commented on the June and September items, I will focus here on the three with the December deadline. These three, as listed on the scorecard, are:
- Complete technical and final reports on a pilot, demonstrating issues and challenges involved in incorporating UDI into a multihospital information system.
- Issue final reports on two pilots demonstrating use of ASTER-D for the detection and automated reporting of select device-related adverse events though hospital electronic health records.
- Pilot an initial functional release of the FDA Adverse Event Reporting System (FAERS), a modernized database for adverse event reports.
Implicit in the first two bullet points is that these items were already underway, given the reference to completing final reports. The FAERS system may be the long-awaited replacement for MAUDE, the public face of MDRs. The FDA itself uses an internal MDR database since MAUDE is admitted to be rather clunky. FAERS is currently identified by the FDA as a reporting system for drug and biologics events, so perhaps this will be an expanded, multicenter system.
The postmarket surveillance program enhancement timeline is only one example of the FDA’s challenging task of setting appropriate priorities and then meeting the associated deadlines. In some cases, this includes dealing with congressional mandates. Perhaps one approach to the FDA doing what it said it would do is for it to create fewer new initiatives before prior initiatives have been completed—or perhaps officially abandoned. This is a good rule of thumb for individuals as well as for the FDA. Promise to do only what you can reasonably accomplish, and then do those things in a timely manner. You will then be respected both for your accomplishments and your reliability.
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. Hyman may be contacted at email@example.com