FDA Will Issue Tougher Validation Requirements for Reusable Devices

Following a spate of superbug outbreaks and deaths from contaminated duodenoscopes and similar devices, the FDA will soon have tougher validation requirements for certain new devices.

According to a notification in the Federal Register, the agency will introduce new requirements for validating instructions for use and for validation of cleaning, disinfection and sterilization in premarket notification submissions for 11 types of devices, including laparoscopic tools and a variety of endoscopes.

The Centers for Disease Control and Prevention linked cases of multi-drug resistant bacteria to duodenoscopes in 2013 and found the infections were happening even though users followed the manufacturer’s cleaning and disinfection or sterilization instructions.

Arthroscopes, laparoscopic instruments, and electrosurgical instruments, and their respective accessories with specific design features “may pose a challenge to adequate reprocessing,” the FDA said. Any 510(k) notification for such devices with specified design features must include the additional validation details. Sleeves, crevices, stopcocks and fittings with very close tolerances are all risky design features listed by the agency as potentially problematic in reprocessing and sterilization.