Medical Device Safety Under Greater FDA Oversight
The U.S. Food and Drug Administration (FDA) announced yesterday its Postmarket Transformation Initiative meant to identify and act on problems with medical devices more quickly. The FDA Center for Devices and Radiological Health reviewed its post-market track record through 2005 and issued a number of recommendations that are shaping this new policy, such as:
- “Working toward an electronic reporting system for adverse medical device event
- Finding ways to identify medical devices including standardized and globally accepted names
- Improving internal collaboration on post market safety issues
- Identifying opportunities to improve the safety of medical devices through collaborative efforts with professional organizations and the medical device industry”
Some of these points simply state that the FDA wants to be organized in a more efficient manner to tackle ongoing monitoring of device safety, but it is interesting to note they also plan to engage manufacturers more actively. The healthcare sector has been relatively less regulated than, typically, drugs. The New York times points out that this follows concerns over the lack of public transparency over data available in public safety reports filed by manufacturers.
January 21, 2006 Related topics: Quality, Safety, Errors