The Rules of Engagement: Reprocessing Medical Devices

One element of standard precautions has come under intense scrutiny in recent years: The reprocessing (cleaning for reuse) of medical devices. The proper cleaning of these devices involves complex protocols to ensure infection prevention, protocols with critical steps - from design to storage- that, if not followed, lead to dire, if not fatal, results. Today’s post will explore medical device reprocessing, who regulates them, and some recent outbreaks associated with cleaning lapses or design flaws.

Medical device reprocessing refers to the cleaning of reusable medical devices. The US Food and Drug Administration (FDA) regulates the design, labeling, marketing, use, and reprocessing of medical devices. They divide medical devices into three categories, each requiring its own degree of reprocessing. While all three categories must be thoroughly cleaned of all surface debris, what comes next varies depending on the device.

Critical Devices 

Enter the bloodstream directly or normally sterile tissue or body-space. These devices must be disassembled (if applicable) and sterilized between uses, as risk of transmission of any pathogen is extremely likely.

Examples | Surgical instruments, endoscopes that enter sterile body-spaces, biopsy accessories.

Semi-Critical Devices

Contact intact mucous membranes or non-intact skin, but their use does not require penetration of tissues. These devices must be sterilized, unless the device design does not permit sterilization, in which case high-level disinfection is permitted. (An example of why a device might not be able to be sterilized is if one of the components cannot withstand sterilization, which requires extremely caustic liquids or intense heat.)

Examples | Duodenoscopes, endotracheal tubes, respiratory equipment, gastrointestinal endoscopes.

Non-critical Devices

Contact only intact skin and do not penetrate tissues, or do not contact the skin at all but may become contaminated during patient care (eg. splashes). These devices should be disinfected according to the extent and type of contamination present. Devices that may be exposed to blood should be disinfected after each patient, and special disinfection will be necessary if exposed to Norovirus, Clostridium difficile, or MDROs.

Examples |  Blood pressure cuffs, stethoscopes, skin electrodes, infusion pumps, ventilators.

While the FDA regulates how the devices must be cleaned and even how the cleaning instructions are written, it is up to the individual medical facility to have the correct protocols in place to ensure that those instructions are followed. They need dedicated cleaning rooms, the proper equipment and chemicals, the trained staff, the proper time allotted for reprocessing, and any other tools needed to meet the requirements of each specific device. Ultimately, it comes down to the people involved to make sure that the device is properly cleaned.

Remember the superbug outbreaks in 2014-15 stemming from duodenoscopes? The outbreak, which led to two deaths and more than 200 infected patients in five states, was directly linked to a specific brand of scope. It turned out that its design prevented it from being completely sterilized, even following the FDA-approved instructions. This outbreak has led to discussions of sterilization requirements for scopes and even their fundamental design. Some design elements are very difficult to clean well – small, moving parts, grooves, joints, or shafts – and manufacturers are now being held responsible for designing devices that are easier to reprocess.

Next week's post will explore the final category of standard precautions, injection safety. There are clear regulations that are in place to prevent infection, but it turns out that they are often not followed. However scary the details, the more you know, the better you are prepared to be a strong patient advocate! 

Editor's Note: This post was originally published in March 2016 and has been updated for freshness, accuracy and comprehensiveness.