FDA Reveals Five MDR Traps That Doom Devicemaker Inspections

FDA inspectors evaluating the adverse event reporting programs at medical device companies are finding a lot of the same problems over and over again, says Sharon Kapsch, chief, MDR Policy Branch, Office of Surveillance and Biometrics, CDRH.

“MDR procedures, or lack of them, are the biggest issue during inspections today,” Kapsch told FDAnews Device Daily Bulletin April 23. FDA wants to help, she added.

“We’ll take a look at a medical device company’s program if they ask,” Kapsch said. “We will provide feedback.”

In addition to weak or missing procedures, FDA inspectors are reporting back to Kapsch and others at the agency that they also frequently observe the following adverse event reporting deficiencies during inspections:

• 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.

Kapsch will be joined by colleague Victoria Schmid, consumer safety officer, MDR Policy Branch, Office of Surveillance and Biometrics at CDRH, and Matrix Resource Solutions President Michael Crader at the Tenth Annual Medical Device Quality Congress in June. The panel will quiz attendees on the state of their adverse event reporting programs and provide feedback directly from FDA officials. “It will also be helpful to us to hear what industry’s concerns are, and where they might be struggling,” Kapsch said.

For more information about the Medical Device Quality Congress, visit www.MDQC2013.com.