Tag Archives: reprocessing

FDA Issues Final Guidance on Reprocessing of Reusable Medical Devices

By MedTech Intelligence Staff
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The new recommendations are outlined in a final industry guidance aimed at helping device manufacturers develop safer reusable devices, especially those devices that pose a greater risk of infection.

The new recommendations are outlined in a final industry guidance aimed at helping device manufacturers develop safer reusable devices, especially those devices that pose a greater risk of infection.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Reprocessing Warning

By Dr. Christopher Joseph Devine
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Dr. Christopher Joseph Devine, President, Devine Guidance International

As FDA recommended in its comments to healthcare, it is imperative that providers inform their patients of all risks. However, it is incumbent upon patients to become knowledgeable consumers and ask questions about any procedure they are being exposed to, including the use of instruments that may have been reprocessed.

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Ask the Engineer

Reusable Medical Devices

By Trabue D. Bryans
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Will FDA accept reprocessing instructions from a predicate device? What do proposed guidelines say about the requirement of multiple markers to properly demonstrate cleaning efficacy? This week’s Ask the Engineer covers some frequently asked questions on this topic.

Will FDA accept reprocessing instructions from a predicate device? What do proposed guidelines say about the requirement of multiple markers to properly demonstrate cleaning efficacy? This week’s Ask the Engineer covers some frequently asked questions on this topic.

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