In thinking about PMS and detection of problems, I thought about the process of notifying FDA and I cam across a NYT article. In the article, the director of healthy policy for the National Center for Health Research in Washington said “It often takes months or even years for the F.D.A. to detect patterns of failure, post-market surveillance of medical devices continues to be dangerously slow and clearly inadequate to protect patients from risky devices.” I never really thought about FDA side of PMS. The article goes on to say that there are approximately 65,000 new adverse events every month and due to volume and number of staff, usually the analyst will review in order of importance, starting with deaths and injuries and malfunctions, but because of the volume when they go in the next day they will again start with the high level risk ones with deaths/injuries. Dr. Shuren believes director of the agency’s Center for Devices and Radiological Health called the current reporting system “passive surveillance.” In this reporting system, FDA relies on manufacturers and hospitals to notify them of injuries, infections and other adverse events linked to medical devices, as well as malfunctions. The guidelines call for alerting the FDA no longer than 30 days after an incident. Dr. Shuren says these reports will become less important as the agency moved toward a new system that he said would mine electronic health records to detect troubling patterns sooner, however, this will take several years.

Overall I think PMS is very important. Some of examples of reports to FDA included; cardiac defibrillators that ran out of batteries; the power morcellator, designed for laparoscopic surgery to remove uterine fibroids, which spread cancer through patients’ bodies; a type of breast implant that is linked to a rare cancer; and the superbug-bearing duodenoscope, whose design flaws made it virtually impossible to disinfect. Reading about these reports, its a little worrisome to me that device companies are asking for 3 month reporting instead of 30 days. I think for something high risk FDA should be alerted within 30 days.

nytimes/2017/07/11/health/fda-medical-device-problems-rules.html