Reusable Medical Device

In FDA, Microbiology, MRO by Ken Eddington

When a medical device manufacturer is preparing a reusable medical device for FDA submission they need to account for several items, including cleaning and disinfection validations.

Performing these validations correctly is vital; they must demonstrate the ability to appropriately and reproducibly clean and disinfect the device following the manufacturers’ published cleaning and disinfecting procedures. Regulations encourage at least one validated automated method using a washer-disinfector be specified unless the medical device cannot withstand the automated process.  Many hospitals prefer automated cleaning procedures to manual procedures because the automated method reduces opportunities for human error, increases productivity and throughput, decreases worker exposure to bodily fluids and can improve cleaning effectiveness.

More reusable medical device manufacturers than ever before are validating automated cleaning procedures for their products. This increase is a result of the multiple advantages offered by automated cleaning as well as an opportunity for the manufacturers to enhance their market position. When selecting a partner to assist with these validations, it is wise to select one with many years of experience who has aided their clients in successfully releasing hundreds of products into the market.

For more than 20 years, NAMSA has offered expert and thorough manual cleaning efficacy validation studies as well as manual disinfection efficacy validation studies. NAMSA has expanded their offerings to include automated cleaning efficacy validation studies and automated disinfection efficacy validation studies using our new, state-of-the-art washer-disinfector. Our experts ensure that the highest quality, newest technology, and latest regulatory expectations are incorporated into our processing/reprocessing validation studies. We accomplish this through our multiple channels of contact with FDA and through active participation in organizations responsible for the development of applicable standards.

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Authors:

Ken Eddington is a Molecular Biologist, Chemist and Geneticist with over 22 years of laboratory, business development and product management experience.