FAQs

Why should we consider reprocessing?

As the need for medical care grows and reimbursements remain constant or even shrink, hospitals must evaluate all opportunities that allow them to continue the superior level of care they deliver. New government regulations to assure the safety of reprocessed and remanufactured SUDs, coupled with the fact that reprocessing and remanufacturing has become a community standard throughout the entire country, means you are not exposing patients to additional risks.

Do we need to inform patients about the use of reprocessed SUDs?

No. SUD reprocessing is codified in federal law and requires FDA 510(k) clearance to assure the reprocessed or remanufactured device is substantially equivalent to the original device. "Informed Consent" implies that there is a different standard for reprocessed or remanufactured SUDs, but there is none.

Will reprocessed products be packaged the same as when they come from the original manufacturer?

In most cases, yes. On occasion, the reprocessed SUD may be packaged differently from how the original manufacturer packaged the device.

How are the reprocessed devices labeled?

Reprocessed devices are required to follow the same regulatory requirements applicable to new devices, including the Code of Federal Regulations, Title 21, Part 801 Labeling, as well as additional requirements that the FDA has enacted for reprocessed single-use medical devices, including the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and Medical Device User Fee Stabilization Act of 2005 (MDUFSA). Following these regulations, Ascent labels reprocessed devices with all or some of the following information depending on the device: (1) "Reprocessed by Ascent Healthcare Solutions," (2) Original Manufacturer’s Name, (3) Original Manufacturer’s Part Number, (4) Description, including size, length, etc., (5) Lot number, and (6) Symbols indicating: "Single Use Only," and "Sterile: Sterilized with ethylene oxide gas," (if applicable).