Compelling Reasons to Reprocess

First and foremost is the safety factor. It has been well documented that reprocessed SUDs are as safe and functional as new devices. As documented in the GAO report, studies showed a rate of less than one tenth of one percent (65 reports out of 320,000) of all adverse events reported between 2003 and 2006 possibly involved a reprocessed device.*

*Source: Guidance for Industry and FDA Staff-Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510k)s) for Reprocessed Single-Use Medical Devices (Issued September 25, 2006)

Reprocessed devices are typically subjected to greater scrutiny and inspection than brand new ones. Each and every SUD that’s reprocessed is closely inspected on an individual basis, while original device manufacturers often test new SUDs in batches.*

*Source: Dan Vukelich, President, The Association of Medical Device Reprocessors, cited in Hospitals Reuse Medical Devices; The Informed Patient by Laura Landro; Wall Street Journal, March 19, 2008

The bottom line is that the FDA tightly regulates reprocessing and there is no proof in any literature or clinical studies that reprocessed SUDs have a higher infection rate associated with their use.*

*Source: Secrets to Saving with Reprocessed SUDs--Outpatient Surgery; Dan O’Connor, Editor-in-Chief, November 21, 2007

For additional information related to the safety of reprocessing, review the following quotes.

With reprocessing shown to be safe and effective, the next compelling reason deals with the financial savings opportunity. Reprocessed SUDs tend to cost only half of new ones and because many devices are able to be reprocessed more than once (up to five times in some cases) the cost savings to a healthcare facility can be substantial.

Today, reprocessing generates hundreds of millions of cost savings each year for healthcare providers...a figure that would grow significantly if every provider embraced the use of reprocessed devices.

Every year insurance reimbursements are decreasing, which is especially concerning in light of a growing population that has an increasing need for medical service. Therefore it’s the financial responsibility of healthcare providers to explore cost effective methods to manage operating expenses and stabilize staff as much as possible, while maintaining the level of patient care. Reprocessing is an ideal avenue to accomplish these objectives.

For that reason it is dismaying that such a huge percentage of the multi-billion domestic market for medical devices is NOT reprocessed, depriving healthcare facilities of significant capital that could be directed at enhanced patient care.

Fortunately, as government regulations have driven safety standards up, reprocessing has become more and more of a healthcare staple throughout the country.

As was reported in the Wall Street Journal *, Sister Susan Vickers, Vice President of Community Health at Catholic Healthcare West explains:

"The safe use of reprocessed devices helps us conserve resources so we can be more cost-effective in delivering care."

*Source: Hospitals Reuse Medical Devices; The Informed Patient by Laura Landro; Wall Street Journal, March 19, 2008

An increasingly important reason to reprocess is the environmental issue. Every year, healthcare facilities literally pour billions of dollars straight into community landfills when they dispose of SUDs. When these devices are discarded, the facility loses an opportunity to save substantial money AND save the environment from additional waste. With only a small percentage of the medical device market currently being reprocessed, it remains very difficult to address the increasing volume of medical waste in our landfills. For example, a single surgery center alone can add thousands of pounds of medical waste every year.

As articulated by Kenneth Kizer, Former Undersecretary for Health, US Department of Veterans Affairs:

"Single-use labeling is a real scam for a lot of devices, and by not using reprocessed devices where possible it is wasteful and not environmentally responsive." *

In support of Kizer’s statement, reprocessing efforts have led to an annual decrease of medical waste exceeding 2,000 pounds...and just as with the financial savings opportunity, this figure will increase as more and more healthcare facilities initiate reprocessing programs.*

*Source: Hospitals Reuse Medical Devices; The Informed Patient by Laura Landro; Wall Street Journal, March 19, 2008

NOTE:
The key is to locate a reputable reprocessing company that can deliver in all of the above areas. The next section covers the types of questions and information to pursue when exploring reprocessing services.