The Food and Drug Administration (FDA) yesterday announced its intention to gather information regarding how a unique identifier system for medical devices could reduce medical errors, facilitate device recalls and improve medical device adverse event reporting. This is largely in response to criticism that the agency has taken for not having a strong enough hold on how devices are performing in actual use once they are cleared for use.
"Much like the bar code rule for drugs and biological products, unique identifiers for medical devices could have many potential benefits for improving the quality of care for patients," said Daniel Schultz, MD, director, Center for Devices and Radiological Health, FDA. "A unique device identifier system could have broad applications in reducing medical errors, facilitating device recalls, improving medical device adverse event reporting and encouraging cost effectiveness by improving delivery and supply chain efficiency."
The FDA is moving with some urgency because the number and complexity of medical devices is on the rise. The agency believes that a UDI (unique device identifier) system may be used to identify a device and the information associated with that device throughout its lifetime. For example, a UDI could identify which devices are compatible, such as implanted devices being used safely with magnetic resonance imaging (MRI) systems.
The FDA is seeking public comment for the next 90 days. The comments will be used to help the agency determine what next steps the agency should take.
Additionally, the FDA commissioned two reports from outside experts on automatic and unique identification of medical devices. The reports found several potential benefits of a UDI system, including identifying incompatibility with devices or potential allergic reactions.
"It is essential that we monitor the performance of medical products after they are approved and make sure that we quickly discover any potential problems that might arise," said Andrew C. von Eschenbach, MD, acting commissioner, FDA. "To improve our postmarket data collection at FDA, we are using a total product lifecycle approach to how we look at medical devices and focusing more attention on the kinds of systems and processes we need to have in place to monitor products after they are approved."
To submit electronic comments, visit www.fda.gov/dockets/ecomments
Additionally, the complete FDA notice is available here: www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm