The company developed the device as an alternative to reusable duodenoscopes, enabling the use of a new and sterile product for each procedure.
The agency wants healthcare facilities to start using duodenoscopes that do not require reprocessing but recognizes the transition will take time.
Strong evidence of proper cleaning and reprocessing that eliminates the spread of bacterial infections is still not there, and improvements are necessary, says Shuren.
Healthcare facilities need to make sure they have enough personnel and equipment that can manage device reprocessing.
The duodenoscope manufacturers didn’t comply with requirements to conduct postmarket surveillance studies assessing reprocessing effectiveness.
The company’s ED-3490TK duodenoscopes require replacement of the forceps elevator mechanism and other parts.
Reusable devices have become more difficult to clean, disinfect and sterilize. FDA is now requiring clear instructions for effective reprocessing.
The agency released a guidance document with product design recommendations to help prevent contamination from device components.
As FDA recommended in its comments to healthcare, it is imperative that providers inform their patients of all risks. However, it is incumbent upon patients to become knowledgeable consumers and ask questions about any procedure they are being exposed to, including the use of instruments that may have been reprocessed.
The way in which we deliver healthcare is changing rapidly. Technology and rapid adoption is enabling device and tech manufacturers to develop products that move the delivery of care away from the clinical environment. Having the option to stay out of hospitals could be extremely important from both a financial standpoint as well as a health perspective, and could essentially help low-risk patients avoid exposure to viruses. Our experts today provide information regarding the regulatory requirements for …