The U.S. Food and Drug Administration (FDA) has released its final guidance on preventing the transmission of infection from reusable medical devices including those that spread superbugs.
On Thursday, the FDA announced new actions that could improve the safety of reusable medical devices and address the threats posed by the potential spread of infectious agents between use of these medical equipment.
Medical devices that are intended to be used repeatedly are commonly found in healthcare settings and these are often made of durable substances with the ability to withstand processes that remove contaminants and soils such as by cleaning and disinfecting or sterilizing to inactivate microorganisms.
A key change involves the manufacturers of these devices. When these companies submit instructions for disinfecting medical device in between uses, the FDA will no longer just take word from the company that the instructions would work. It would demand proof.
FDA's move followed an incident last month when hundreds of patients were feared to have been exposed to pathogens including a drug-resistant superbug after flexible tubes known as duodenoscopes were used between patients without it being properly disinfected. The incidence has resulted in the deaths of two patients at the University of California-Los Angeles.
"As part of its regulatory review for reusable medical devices, the FDA reviews the manufacturer's reprocessing instructions to determine whether they are appropriate and able to be understood and followed by end users," the FDA said in a statement. "The guidance also recommends that manufacturers consider reprocessing challenges early in device design."
The duodenoscopes is an important medical device used in about 500,000 procedures in the U.S. annually. The FDA said that while most reusable devices are reprocessed successfully, some devices have designs complex enough to make it challenging to remove the contaminants.
The reusable precision instrument can be particularly difficult to clean and sterilize. Besides duodenoscopes, most medical devices that will be used repeatedly, which include endoscopes and bronchoscopes, need to adhere to the new recommendations.
William Maisel, from FDA's Center for Devices and Radiological Health, said that regardless of recent concerns about superbug infections linked with reusable medical devices, duodenoscopes, in particular, the risks of getting infected from a reprocessed medical device is low.
He also said that the guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," could provide better assurance to patients that the devices that are used on them are safe and effective.
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