A broad international regulatory trend toward regulating medical devices after they are purchased and in use by the customer has been building for some time. Many other countries do not recognize the "veil of commerce" as a barrier to further regulation. So, in January the FDA announced their Medical Device Postmarket Transformation Initiative, the result of more than a year of planning and preparation. This new program will ensure effective monitoring of medical devices for continued safety after they are in use. The current approach has the following problems:

  • Adverse events are widely under-reported by users
  • Many reports contain inadequate information about the device used and possible causes
  • Identification of the specific device (after the fact) is problematic
    • Device use is typically no documented in patient records
    • Devices lack unique identifiers
    • Manufacturers continually produce modified versions of products
  • Devices are frequently used "off-label"

The new program has three key components: postmarket problem
identification, problem assessment, and public health response. Problem
identification will use the medical device reporting system and reports
from hospitals to gather information. Problem assessment will be done by teams of FDA staffers and
consultants who will analyze those data and determine the nature and
magnitude of each problem. Reponses will range from urgent alerts and media
outreach to enforcement actions.

The actual impact of this initiative on medical device vendors, vendors of products that "extend" medical devices (like secondary alarm systems), and users remains to be seen.