I received this early this morning. It is such a critical issue I wanted to share it with you in case you had not yet received the recall notice. It is also a great opportunity to demonstrate how the Unique Device Identifier (UDI) will be extremely beneficial when implemented by the Healthcare Industry.

[The FDA recall released March 12, 2010 stated - The U.S. Food and Drug Administration today warned healthcare providers and consumers about counterfeit surgical mesh being distributed in the United States under the C. R. Bard/Davol brand name.]

The warning is of particular significance to health care professionals and their patients with surgical mesh implants as well as hospitals and surgical centers, operating room medical professionals and staff, and purchasing and risk managers.

I have included a link to the FDA recall notice that was released this morning. A subscription to this service is free and provides a quick heads up on critical issues. The link is http://www.fda.gov/NewsEvents/Newsroom/Press
Announcements/ucm204199.htm. When you read the recall you will see that the Manufacturer has provided the product numbers and descriptions along with the lot numbers for each item. If the product numbers had been substituted with the Universal Product Number (UPN) then the manufacturer could have constructed a UDI for each of the products at each packaging level and lot number. This manufacturer has been labeling with the UPN for several years, so the data would be available.

Inputting this information into your Materials Management Information system and having the ability to scan the product immediately prior to use on a patient has the potential to save lives.

If the MMIS and Clinical Systems were properly configured, this work could be done electronically and as a routine process. Once uploaded then your staff could quickly assess the situation and begin the recovery. It would also add a safeguard should the product be transferred from another facility in the future.

Most products have the UPN labeled on them, including more than 60% of the unit of use. All products have the lot/batch number and expiration dates printed on the package, many of which have already implemented the standards to barcode these critical data elements.

When the UDI Database (UDID) is implemented and the industry has adopted the requisite software changes in both the clinical and administrative information systems, the process will be greatly improved and the risk to the patients greatly reduced.

Please share with your colleagues and let me know if you have any questions on this matter.

Thanks,