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 SUDs, coupled with the fact that reprocessing 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 device is the same as the original. Informed Consent implies that there is a different standard for reprocessed SUDs, but there is none since the federal government has stated that Ascent’s reprocessed devices are as good as new.

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 than the original manufacturer packaged the device.

How are the reprocessed devices labeled?

Ascent labels all reprocessed devices with the following information as mandated by the FDA: (1) Ascent Healthcare Solutions, (2) Original Manufacturer’s Name, (3) Original Manufacturer’s Part Number, (4) Description, including size, length, etc., (5) Lot number, (6) Symbols indicating: "Single Use Only," "Sterile: Sterilized with ethylene oxide gas," (if applicable) and (7) The statement "Reprocessed by: Ascent Healthcare Solutions."

Who is liable for a reprocessed SUD that fails?

Ascent Healthcare Solutions accepts the liability for any SUD we reprocess. We have an excellent safety record and the company maintains a $25 million liability insurance policy, more than many U.S. hospitals presently carry.

What should we do if a reprocessed SUD fails?

Follow the same protocols and practices you currently do when a new SUD fails, then contact your Ascent representative and he or she will complete the necessary paperwork and send the device to Ascent engineers for review. Ascent will analyze the failed device and submit to you a written report on their findings. You may be called upon to provide additional information prior to the closing of your issue. Investigations of this nature could take between four and eight weeks depending on the complexity of your issue.

What about charging for reprocessed SUDs?

Hospitals typically bill and get reimbursed for the services they provide, not the devices used in providing the service. As such, SUDs reprocessed following FDA requirements are the same as the original. The Centers for Medicare and Medicaid Services (CMS) has stated that single-use devices reprocessed according to FDA guidelines would be treated the same as the original.