A group of provider, consumer, research and health quality groups are pushing the FDA to publish planned rules requiring a unique identification system for medical devices. The Advancing Patient Safety Coalition, which includes the American Hospital Association, Federation of American Hospitals and American Association of Medical Colleges, contends that the unique device identification system is crucial to cutting errors, improving device adverse event reporting and improving post-market surveillance efforts. Federal legislation in place since 2007 requires the use of unique identifiers to label medical devices, though it doesn't say which types of devices should be labeled. The FDA has been considering the matter since 2005, working with industry stakeholders to determine which devices should be identified, and how.
To learn more about the coalition's aims:
- read this Health Data Management article [1]
Links:
[1] http://www.healthdatamanagement.com/news/identifier_medical_devices26027-1.html