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Device Users Stress Need For Proper Manuals, Training To Support Refurbishing

 
• By Sue Darcey

Participants at a recent FDA workshop on refurbishing, reconditioning and servicing used medical devices emphasized the need for manufacturers to continue to make correct manuals and spare parts available for user-facilities to maintain older devices, and to oversee input into product training. The need for standards to certify or accredit those who refurbish or service used devices was also emphasized at the meeting.

Both hospital purchasers and biomedical engineers who have to maintain refurbished and reconditioned devices say they run into problems obtaining well-written maintenance manuals and the correct parts needed to keep the products in good condition. That was the message from participants at a recent FDA workshop.

The purpose of the Oct. 27-28 workshop was to discuss potential regulations or standards that might support third-party processes for...

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