From the August 2007 issue of "The Silver Sheet"
The number of adverse events reported to FDA under the Medical Device Reporting (MDR) program rose last year to an all-time high, and agency staffers predict the trend will continue through 2007.
According to CDRH's Office of Surveillance and Biometrics (OSB), there were 325,742 reports of device-associated injuries, deaths and malfunctions in calendar year 2006 - a 77% increase over 2005, when 184,222 reports were filed.
"Just wait until 2007 is here. At this point we are anticipating a higher number [of MDRs] than last year," said Mary Brady, a deputy division director in OSB. "It all depends on how manufacturers are choosing to report, what they are reporting, and what they consider a reportable event."
Brady said the spike may have occurred because device firms have been reviewing and adjusting their reporting procedures.
"Our compliance group has been working a lot with many different manufacturers over the last few months," she said. "We have been going through their procedures and [the firms are] saying, 'We need to change our decision-making tree for reportability.' I have a feeling that's probably a big part of it."
Although FDA cannot instruct firms word-for-word how their MDR procedures should read, OSB Director Susan Gardner encourages companies to contact FDA if they have questions.
"Most firms set up some sort of decision tree or some sort of procedure to evaluate their MDR complaints. We're more than happy to look at those procedures. We're more than happy to answer their questions, and do all the time," she said.
FDA explained its MDR requirements for injuries reported by consumers or described in scientific journals in a recent warning letter to Medtronic.
- Shawn M. Schmitt
An in-depth discussion of MDR reporting appears in the August issue of "The Silver Sheet."
CLICK HERE to sign up for a free trial of "The Silver Sheet."
