Microtest Adds New Technology to Help Device Manufacturers Meet FDA Cleaning Validation Requirements

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Microtest Laboratories is employing new state-of-the-art technology to assist manufacturers of reusable medical devices ensure that they meet Food and Drug Administration (FDA) requirements for cleaning validations.

Many manufacturers of reusable medical devices only create a set of instructions on manual washing — although automatic washing is gaining popularity. But the FDA requires that manufacturers validate that all sets of cleaning instructions and meet the parameters indicated on a reusable medical device’s labeling.

Microtest Labs acquired a new Getinge 46 series automatic washer/disinfector — used to reprocess soiled reusable medical devices so they can be used again for subsequent procedures. The washer removes soil and performs a low level disinfection of reusable medical devices — thus removing the variability of manual reprocessing.

Technicians at Microtest Lab will use the new system to expand and supplement their consulting services with manufacturers. “By working with manufacturers to develop and validate a set of autowashing parameters, we are helping to ensure that their devices will be processed faster and more reproducible. This saves time and costs — and helps reduce the future possibility of a soiled device being used by a healthcare professional,” says Philip Nosel of Microtest Labs.

The company has recently published a management brief summarizing the FDA’s requirements for automatic washing cleaning validation and discussing the benefits of automatic washing. The brief, “Automatic Washer Validation for Medical Device: Are you in Compliance?,” is available for download at: http://microtestlabs.com/automatic-washer-validation.

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