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New Validation Rules in Effect for Disposable Devices

New Validation Rules in Effect for Disposable Devices


To prevent the possible spread of harmful germs, the U.S. Food and Drug Administration recently compiled a list of reusable medical devices that will now require validated instructions and data on use, cleaning, disinfection and sterilization to be used in pre-market notifications. The new regulations place greater focus on the effectiveness of disposable medical devices.

Contamination incidents
As reported by the Regulatory Affairs Professional Society (RAPS) the new requirements come as a result of outbreaks of the superbug Carbapenem-resistant enterobacteriaceae (CRE) at two West Coast hospitals – Virginia Mason Medical Center in Seattle and UCLA Ronald Reagan Medical Center in Los Angeles. The two facilities were found to have both used the device known as a duodenoscope.

In addition, a study in the U.S. National Library of Medicine on laryngoscope handles found that 75 percent of the handles tested positive for bacterial contamination, including coagulase-negative staphylococci and α-hemolytic Streptococcus. Through their finding, the researchers recommended a minimum low-level disinfection process after each patient use.

Following the West Coast incidents, the FDA issued a safety alert regarding cleaning of the devices but a Senate report the next year questioned the agency’s system for post-market tracking of devices.

The list of devices is part of the 21st Century Cures Act, signed into law in December 2016 and which seeks to “accelerate product development and bring new innovations and advances to patients who need them faster and more efficiently,” according to the FDA. The act followed a 2015 safety alert from the FDA.

Specifically, the act requires the FDA to identify and publish a list of the reusable medical devices that must include instructions on use, as well as data that validates cleaning, disinfection and sterilization.

Categories of devices
The list includes the following categories of devices: flexible and rigid bronchoscopes and accessories; eye, nose and throat endoscopes and accessories; gastroenterology and urology endoscopes that have elevator channels; automated reprocessors for reusable devices, neurological endoscopes; arthroscopes and accessories; laparoscopic instruments and accessories and electrosurgical instruments and accessories.

Among the design features which the FDA stated may pose a challenge are: interior device channels, hinges, depressions, joints with gaps, o-rings, lumens (particularly lumens with flexible designs and multiple interiors, those that are not easily accessible or are too small to insert a brush easily; and shafts with lumens.

In a statement by the FDA and re-posted by RAPS, the agency said it is confident many reusable devices are already in compliance with the rules.

“FDA believes that a majority of manufacturers for the reusable devices listed below are already conducting validation of their reprocessing instructions because FDA already has provided recommendations for reprocessing validation in relevant FDA documents,” the statement read.

In their 2015 report entitled “Final Guidance for Industry and FDA Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling,” the agency stated, “The final guidance document reflects the scientific advances in knowledge and technology involved in reprocessing reusable medical devices, many of which have become highly complex in design and are more difficult to reprocess.”

The devices on the list, the FDA reported, have the greatest risk of transmitting infection if they are not adequately cleaned and reprocessed. They added that it is possible the agency will reassess the items included on the list in the near future.

According to the FDA, the job of reducing the likelihood of repeat outbreaks like the ones at Virginia Mason and Ronald Reagan Medical Centers is the responsibility of all members of the medical community including: the agency, device manufacturers whose duty it is to supply reprocessing directions that are easily understood and tested; medical facilities tasked with cleaning and sterilizing the devices, and other stakeholders.

Cleaning not enough
But even the current process of cleaning devices does not guarantee their cleanliness, as the aforementioned incidents and research suggest. Even following the manufacturer’s recommendations, it’s possible that the instruments may still contain contaminants deep inside because the cleaning process was not done in a timely manner or the devices have components that are not accessible for optimal cleaning. These components can include accessories such as light sources which are not cleaned on a regular schedule.

This reality makes single-use devices a reliable option to reduce the risk of cross contamination down to nearly zero. A single-use device such as the OBP SURE-SCOPE Single-Use laryngoscope with integrated LED light source can help a facility maximize its infection control program and deliver quality care to all of its patients.

The ready-to-use SURE-SCOPE has an integrated LED light source that eliminates the cost and time associated with reprocessing traditional devices. In addition, SURE-SCOPE arrives individually packaged in sterile packaging for additional protection.

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