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Regulatory Focus™ > News Articles > FDA Reassures Consumers About Risks Associated With Reused Medical Devices

FDA Reassures Consumers About Risks Associated With Reused Medical Devices

Posted 29 December 2011 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) announced Wednesday that it is working with healthcare providers, manufacturers, standard-setting organizations and government agencies to "reduce the risk of infection from the inadequate reprocessing of medical devices intended for repeat use."

The FDA noted that it has received reports of patients being exposed to biological products as a result of inadequate sterilization after use.  However, FDA also noted that transmission of infection as a result of these biological products-including blood, tissue, and body fluids-was extremely rare.

The deputy director of the Center for Devices and Radiological Health (CDRH), Bill Maisel, M.D., said that the benefits of using such devices far outweigh the low risk of acquiring an infection.

Patients are advised to ask their healthcare providers about precautions taken to promote the sterility of their products.  FDA is further working with manufacturers and providers to promote clearer instruction manuals for repeat-use devices and generate best-practices for sterilization. 

The FDA is making information available to consumers, providers and manufacturers at a new web page devoted solely to the issue. 


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