Medical Device Validations for Patient Safety

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March 2022

Contaminated environmental surfaces can cause HAIs. However, some of the most concerning HAIs come from breakdowns in the cleaning and disinfection of reusable medical devices, such as endoscopes.

One does not have to look far to find tragic examples from common reusable devices like duodenoscopesbronchoscopes, and uroscopes.

At their core, HAIs from contaminated, reusable medical devices come from one of three things:  Inadequate cleaning and disinfection procedures, antiquated device designs that are effectively uncleanable, or operator oversights in cleaning and disinfection.  The responsibility for all but operator oversight lies with the medical device company, and Microchem is here to help.

The first step of reusable medical device reprocessing is cleaning, which removes patient fluids from the device such that disinfection can take place without interference from excessive biological material. Surfactants, scrubbing, and submersion are common elements of a successful cleaning procedure. Submersion is not a viable option for many medical devices due to non-removable electronics, so the use of detergents and scrubbing are crucial.  Microchem can help your company ensure that cleaning agents reach the places soils hide and there is sufficient mechanical action to dislodge them.

Device design – which comes long before cleaning and disinfection validation testing – is arguably the most important factor in reprocessability.  Some medical devices just can’t be adequately cleaned or disinfected without extraordinary reprocessing procedures. Seams, recessed screw heads, and the like are ideal hiding spots for biological material. Due to the wicking action of these sorts of configurations when inoculated, they can drive failure after failure in reprocessing.

If a device is relatively smooth and seamless, and mechanical action is used in cleaning and disinfection procedures, reprocessing success is likely. In Microchem’s experience, devices that are difficult to clean to FDA’s high standards have even greater challenges when it comes to disinfection validation.

Microchem Laboratory uses AAMI technical reports, published medical device studies, FDA guidance documents, and our experience and expertise to offer GLP- and ISO-compliant cleaning and disinfection validation services for medical device manufacturers. Microchem can evaluate high-, intermediate-, and low-level disinfection based on the intended use of a medical device, and we can evaluate cleaning procedures using quantitative soil markers such as total protein, hemoglobin, and carbohydrates. The Medical Device Validation Team also offers preliminary disinfection validations using fluorescent soil markers for general R&D purposes.

To learn more about validation requirements and Microchem’s capabilities, please reach out to the Team Lead of the Medical Device Validation Team, at 512-310-8378, extension 3#, or via email at [email protected].

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Medical Device Validations for Patient Safety

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Recent Articles