Last year, FDA received almost one million adverse event reports from manufacturers1. Needless to say, the Office of Surveillance and Biometrics has been very busy, and so have manufacturers.

A number of articles I’ve read recently have suggested that medical device reporting has been on the rise in recent years due to changes manufacturers have made in their complaint handling and reporting procedures. Take Intuitive Surgical, the makers of the da Vinci System, for example. The number of reports filed has increased, however it may not necessarily be due to an increase in adverse events. The firm states that they recently changed their reporting criteria, and are now reporting more malfunction-related MDRs than before2.

Many of these changes to MDR reporting practices have been spurred by FDA Warning Letters and inspection findings. According to an FDA News Bulletin, deficiencies in adverse event reporting are commonly found by FDA inspectors in the following areas3:

  • Companies are unclear on how the agency wants them to define “likely” when assessing whether a malfunction is likely to cause or contribute to a death or serious injury if it reoccurred;
  • Company employees are confused about what constitutes a reportable event and what does not when asked about it during onsite inspections;
  • Companies haven’t included appropriate time frames and deadlines in their adverse event reporting programs; and
  • Training is often inadequate. “All staff should be trained. Anyone who answers the phone should know what to do if it’s an adverse event call,” Kapsch said.

As a result, we’ve seen the number of MDR’s submitted skyrocket. Who actually has the time to look at all of them? Adverse event reporting enables FDA to take corrective action on problem devices and prevent injury and death by alerting the public when potentially hazardous devices are discovered4. FDA is looking at the reports, your competitors are looking at the reports, and your customers and potential customers are looking at the reports. However, I imagine with the large set of data that we now have to sift through, it is becoming increasingly difficult to make heads or tails of anything. There are a number of groups pushing the cause to streamline data collection and analysis, and as time moves on, I think we’ll be seeing some more focus on this area.

- Sherri

  1. Adverse Event Reporting Hits All-Time High; FDA Warns Firms About MDRs, Complaint Handling; The Silver Sheet; Shawn Schmitt.
  2. Intuitive Surgical Denies Increase in Adverse Events with da Vinci System; QMed Daily
  3. FDA Reveals Five MDR Traps that Doom Devicemaker Inspections; FDAnews Device Daily Bulletin;
  4. Adverse Event Reporting for Medical Devices; Office of Inspector General;

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