Expert Recall

By Brett Berty

The Food and Drug Administration (FDA) has proposed a new rule requiring manufacturers, importers, hospitals and medical offices to report adverse events pertaining to medical devices to the agency in digital format. The proposed electronic Medical Device Reports, or eMDRs, would more quickly gather information about adverse events, such as death or serious injury, due to product failure or malfunction so that corrective or preventative actions can be taken.

The FDA believes that electronic MDR filing will not only save the agency significant administrative costs in handling overwhelming volumes of information, it will more importantly help them ensure consumer safety by immediately identifying situations where the consumers are at risk.

In general, manufacturers are in a good position for meeting this deadline – as are the hospitals and medical community at large. More than 90 percent of companies are already capturing consumer input electronically.

Manufacturers who are already using the eMDR are reporting no major problems or errors. The risk is minimal – provided the company is prepared ahead of time to handle the new proposed adverse event reporting requirements and respond quickly to findings from the electronically filed information.

For those parties who haven’t already adapted to the eMDR reporting system, it is critical that they be prepared should the new rule take effect. There are several first steps to take in order to get prepared:

• Companies need to evaluate their current software to determine whether it is compatible with FDA reporting requirements.

• The FDA is providing software tools to ease the burden. Companies can go to the FDA website and download programs that might facilitate the transfer of data. Tools for Electronic Medical Device Reporting are discussed on the FDA website.

• Additional “middleware” might be required to interface between the company’s software and that available from the FDA. IT departments can make that determination quickly and the cost to purchase and install should be minimal.

• Companies need to beta test all the components together to ensure that the transfer of information is seamless and meets FDA standards.

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