AMDR, AdvaMed at Oddsover Reprocessed SUD Applications

Originally Published MDDI October 2003

NEWSTRENDS

AMDR, AdvaMed at Odds over Reprocessed SUD Applications

Erik Swain

Reprocessors and manufacturers of single-use devices are at odds over whether similar reprocessed devices from multiple OEMs should be bundled in the same 510(k) submission.

On August 8, 2003, the Association of Medical Device Reprocessors (AMDR; Washington, DC) submitted comments to FDA encouraging it to continue allowing such bundling.

AMDR said the regulatory and technical issues raised by reprocessing are similar for devices of the same generic type. Therefore, it said, it is more efficient for the agency to review them in the same application.

“Requiring individual submissions for the reprocessing of each model or version of a generic type of device would have a negative impact on efficiency without any corresponding public health benefit,” AMDR wrote. It argued that cleaning, testing, and sterilization protocols for multiple versions of a generic type of device are “extremely similar, if not identical.” 

In contrast, the Advanced Medical Technology Association (AdvaMed; Washington, DC), in a January 22, 2003, letter to the agency on bundling issues, argued that there are many differences between devices from multiple OEMs. It asked the agency to change its policy of permitting bundling in those cases.

“Differences between devices from multiple OEMs (e.g. in the designs, materials, manufacturing processes, sterilization techniques, performance, etc.) necessitate separate validations be conducted in order to adequately ensure the safety and efficacy of the reprocessed devices,” AdvaMed wrote. 

AMDR's letter charged that AdvaMed had no proof for that claim. AdvaMed says it will respond to AMDR's comments in a letter to FDA this fall. 
—ES

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