Update June 2, 06

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Update June 2, 06

June 2: ERG Final Report: Unique Identification for Medical Devices

This report is been prepared by Eastern research group for FDA examining the outlook for implementing some type of UDI system for medical devices. FDA is reconsidering whether some form of unique device identification (UDI) is warranted for medical devices, given the potential of UDI to help reduce medical errors, facilitate recalls, identify incompatibility with devices or potential allergic reactions, improve inventory control, improve reimbursement, and reduce product counterfeiting.

This report highlights the current regulations and current use of medical device identification for medical devices. Report also reveals the result of survey conducted on the use of bar coding in medical device industry. Then potential benefits of UDI and interests of stakeholders is been discussed. Report then delineates several scenarios which are been identified by FDA that illustrate issues potentially associated with insufficient identification or tracking of medical devices. Responding to the scenarios raised by FDA, report addresses each problem, and gives opinion about potential means of rectifying the problem. Report also gives the gist of steps involved in implementing UDI and possible challenges. Finally report concludes regarding the potential government role in unique device identification.

To Access complete report, please refer the following link http://www.fda.gov/cdrh/ocd/udi/erg-report.html

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