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The Steps In Medical Device Cleaning Validation

It is more common today than ever to use a medical device or a medical instrument more often than once. While this has always been true for surgical instruments and other types of devices, it is becoming more common with simpler items as well, particularly with the use of new materials that are designed to enhance the antimicrobial action and offer a longer life cycle.

In hospitals, clinics, doctors’ offices as well as in long-term care facilities, medical devices may need to be routinely cleaned for use with various patients. This will result in the need for the facility to have a medical device cleaning validation process in place.

The Reason

Even when using ultrasonic cleaners, medical equipment washing systems, sterilizers and other devices for cleaning, it is impossible to determine if the cleaning devices are operating correctly to achieve the full sterilization and decontamination required.

By having a separate medical device cleaning validation process that can test the equipment functioning through the process or test the equipment after cleaning there is a clear method to demonstrate the effectiveness of the system.

What to Test

Generally, medical device cleaning validation will focus on specific substances. For example, in dialysis centers, there will be a need to test for formaldehyde residue. In other types of medical equipment cleaning using ultrasonic cleaning and enzymatic detergents, there is a need to test for mechanical action during the cleaning cycle, the temperature of the water, enzymatic cleaner effectiveness and time of contact. For surgical equipment, there will be a need to test for high-level disinfectants including GTA and OPA.

Simple, easy to use test strips are the most effective option for all these testing needs. Not only are they user-friendly, but they provide results in just minutes that offer a simple color match to determine results.

Alina alford

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Medical Device Cleaning Validation: Manufacturers, The FDA And End Users

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