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Single-Use Device Reprocessing: Balancing Cost Savings, Patient Safety

HCPro, July 13, 2010

At a time when hospitals are continually searching for ways to reduce costs while maintaining or even increasing their focus on patient safety and infection control (IC), reprocessing single-use devices (SUD) may be a viable option that is cost-effective and environmentally friendly.

The idea of reprocessing SUDs may seem inherently incorrect to some, but doing so with appropriate devices through an FDA-regulated third-party vendor can significantly reduce waste and save your facility thousands of dollars in purchasing costs while maintaining quality care.

Reprocessed SUDs range from low-risk devices such as blood pressure cuffs or compression sleeves to high-risk devices such as balloon angioplasty catheters or implanted infusion pumps. But because these devices are labeled for single use, some healthcare providers worry that the risk to patient safety is greater than the need to save money or reduce waste.

However, according to a 2008 report from the Government Accountability Office, FDA oversight on reprocessing SUDs has increased, and data, although limited, did not indicate an elevated health risk to patients. A survey conducted by the FDA in December 2001 to February 2002 found 24.2% of all U.S. hospitals reused SUDs. Now as many as 68% of the Practice Greenhealth ?Partners for Change? award applicants have implemented SUD reprocessing, according to Janet Brown, director of facility engagement at Practice Greenhealth.

In a recent commentary published in Academic Medicine, lead author Martin A. Makary, MD, MPH, the Mark Ravitch Chair of Gastrointestinal Surgery and director at the Johns Hopkins Center for Green Health in Baltimore, argued that reprocessing is a green practice that is gaining traction in the healthcare community because of the cost savings and the reduced burden of waste on the environment.

?We have found it to be a common-sense strategy that uses detailed quality-control standards to recalibrate, clean, sterilize, and remanufacture medical equipment,? the authors wrote. ?The result has been a significant waste reduction and cost savings. However, uptake of such green practices by hospitals has continued to be slow because of a misunderstanding of the process and concerns about patient safety.?

What is reprocessing?

Essentially, reprocessing involves sterilizing equipment that has been used or opened so it can be safely and effectively used again. Reprocessed devices are typically given to third-party vendors rather than being handled in-house. These vendors are regulated by the FDA.

Each device is subject to premarket notification requirements set forth by the FDA. Manufacturers are required to submit 510(k)s to the FDA for that device to be approved for reprocessing.

Healthcare facilities can collect approved devices, send them to their third-party vendor, then buy the reprocessed devices back at nearly half the cost of purchasing new ones.

Reprocessed SUDs are divided into three groups: critical, semicritical, and noncritical. Healthcare facilities will often start small by simply reprocessing noncritical devices rather than focus on every device in their facility. ?I don?t think I?ve met a hospital that is reprocessing everything the FDA says they can,? Brown says. ?But I think they are working in that direction.?

Getting started

Although you may face resistance from physicians or patient safety advocates initially, the best way to begin reprocessing SUDs is by starting with less-critical items, such as compression sleeves. This will net a cost savings and reduce waste within your facility while easing employees into the process and proving its effectiveness.

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