The self-driving UV disinfection robots are being sent to more than 2000 hospitals.
During an outbreak, it is critical to treat reusable medical devices as potential sources of transmission.
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.