U.S. Regulators Tighten Requirements on Reusable Medical Devices
Thursday, March 12, 2015
U.S. health regulators on Thursday announced strict new recommendations for preventing the transmission of infections from reusable medical devices such at those that have spread "superbug" infections at several hospitals.
A key change is that when manufacturers submit instructions for disinfecting the devices between uses, the Food and Drug Administration will not take the company's word that the instructions work, but will demand proof.
The FDA action followed reports last month that hundreds of patients may have been exposed to pathogens, including antibiotic-resistant "superbugs," after flexible tubes called duodenoscopes were not properly disinfected between patients. Two patients at the University of California-Los Angeles died.
The new recommendations apply, however, not only to duodenoscopes but to most medical devices intended for repeated use, including bronchoscopes and endoscopes.
To deal with the thousands of devices already in use, whose disinfection protocols were not subjected to rigorous validation, the U.S. Centers for Disease Control and Prevention released instructions for reducing the risk of transmitting infections.
As previously reported by Reuters, the protocol calls for swabbing the device after it has supposedly been disinfected and seeing if any microbes grow into detectable colonies, much as doctors take throat swabs to determine if a patient has a strep infection, before the device is used again.
The duodenoscopes at the center of the recent superbug outbreaks are made by Olympus Corp, Fujifilm Holdings Corp, and Pentax.