After a deadly “superbug” contamination left hundreds of patients ill and fighting for their lives in numerous hospitals across the country, the U.S. Food and Drug Administration (FDA) has announced they’re taking action to prevent such incidents in the future.
The defective medical device lawyers with Ferrer Poirot Feller explain that hospitals are required to vigorously clean all devices and equipment used to perform procedures. Sometimes though, the sanitation steps that are taken just aren’t enough.
Officials have determined this lack of effective sanitation procedures is what allowed a drug-resistant strain of bacteria called carbapenem-resistant Enterobacteriaceae, or CRE, to be spread through specialized endoscopes.
The devices were used to gather images from inside the bodies of patients to determine what was ailing them. However, when the devices were not being effectively cleaned, patients were exposed to the CRE superbug.
This lack of effective sanitation prompted the FDA to issue a press release with a new set of standards to be utilized when sterilizing medical devices that are reprocessed.
The new standards require more extensive safety testing before the device can be released to the public. Manufacturers of medical devices are also encouraged to take reprocessing into consideration when designing new products.
At Ferrer Poirot Feller , our drug injury attorneys are hopeful the new procedures being implemented will reduce the rates of hospital-acquired infections in patients after medical procedures.