The ins and outs of third party reprocessing

The lifespan of medical devices is growing longer as more and more hospitals are turning to device reprocessing to cut costs, reduce waste and maximize potential use of these items.


Millions of single-use devices are used daily in healthcare facilities across the country. Instead of throwing away devices after use, third-party reprocessors refurbish them back to original manufacturer specifications so hospitals can reuse them, saving money and eliminating waste while still assuring clinical quality and safety for patients.


The role of reprocessing

There are two main types of reprocessing: in-house and third-party. In-house reprocessing is done in a hospital's facilities where they can reprocess reusable devices, such as stethoscopes, colonoscopes and surgical forceps. Hospitals follow a general three-step process of cleaning, decontaminating and sterilizing products in their reprocessing facilities.


However, most hospitals are unable to adequately meet strict FDA requirements for reprocessing "single-use devices," a label that originated by equipment manufacturers for which the U.S. Food and Drug Administration now defines as a device intended for one use on a single patient during a single visit. Common single-use devices include tissue stabilizers, diagnostic ultrasound catheters and general surgery tools.


Third-party reprocessors

For such single-use devices, third party reprocessors step in to restore them back to their original specifications. Unlike in-hospital reprocessing, the entire third-party process is overseen by the FDA.


"It's the same sort of process that any device manufacturer would go through," says Kevin Liszewski, vice president of marketing for Stryker Sustainability Solutions, a third-party reprocessing company. "The goal is to determine the device is safe and effective. Original manufacturers submit data on how it's made, how it's supposed to work and what it's supposed to be used for. We have to do the same thing, but also provide data showing we know how to clean it, sterilize it and test it so we know it's equivalent to its original specifications."


Holding reprocessors to the same standard as manufacturers ensures clinicians the reprocessed devices they are using are just as safe and effective for their patients as brand new ones. To reach that level of assurance, third-party reprocessing involves rigorous cleaning, testing, repackaging and sterilization, among other steps, and only devices the FDA deems fully functional and equivalent to original specifications will be returned to hospitals.

Mr. Liszewski says Stryker has noted an increase in hospitals choosing to reprocess devices with third-party reprocessors over the years.


"As [hospitals] see the quality of devices and financial value that we deliver and the environmental impact, they will expand their program year over year," he says.

For example, Parallon Nashville Supply Chain Services is one company that utilizes Stryker's third-party reprocessing for its facilities. William Kellar, CEO, says their facilities decided to pursue third-party reprocessing after undergoing value analyses.

"Reprocessing was a natural fit from the perspective that we were already responsible for the purchasing of the original equipment manufacturer products," he says. "It seemed like the right thing to do, both environmentally and economically."

FDA approval

FDA oversight on third-party reprocessing began in 2000. Daniel Vukelich, president and CEO of the Association of Medical Device Reprocessors, says this indicated a turning point in how devices were to be reprocessed.


"The FDA put in place requirements that said anybody that's reusing single-use devices is henceforth going to be treated as a manufacturer, regulated by us," Mr. Vukelich says. "At that point, any hospitals reusing single-use devices in-house just by cleaning them and sterilizing themselves had to stop or meet manufacturer requirements," he says, adding no hospital in the past 14 years has been able to meet those requirements with in-house reprocessing.


Although hospitals are increasingly turning to third-party reprocessors, Mr. Vukelich says the change was met with some resistance.


"A lot of times manufacturers in any industry resist regulation. They see it as something that will drive up cost," Mr. Vukelich says. "AMDR member companies in the late 90s had the vision to see that FDA regulation of all products would mean legitimization. When a doctor or nurse picks up a reprocessed device, a single-use device, that means the device they're picking up has received the same level of scrutiny by the FDA as any other device. They have that peace of mind that this is an FDA-approved product."


Mr. Kellar says Parallon had to slowly integrate the idea of reprocessing into their facilities and ensure clinicians that the instruments and devices were up to original equipment manufacturers standards by the FDA.

"Clinical adoption by the physicians and clinicians was not immediate and not without issues," Mr. Kellar says. "It was imperative that we addressed the counter detailing by the OEMs with our physicians and staff. In addition, we had to take the time to educate the staff on how products were reprocessed."


For other facilities interested in third-party reprocessing or that may be encountering some initial resistance from staff, Mr. Kellar suggests organizations start reprocessing non-invasive types of items first to introduce the concept to the hospital staff. "Use this as a foundation for building your program and developing the clinical support to consider other high dollar OR supply items where staff and physicians tend to be more resistant to the concept," he advises.


Economic and environmental benefits

As with all reused items, the cost benefits and impact on the environment are hard to ignore. Agreeing with Mr. Kellar's earlier comments, Mr. Liszewski says third-party reprocessing is one of the most effective and impactful resource management strategies hospitals can undertake.


"Hospitals are being asked to do more with less," he says. "They're seeing diminishing reimbursements. At the same time, they have to have increasing demand for high quality care."


Third-party reprocessing hits both those aims with the same bullet, he says.


"By reprocessing single-use devices with Stryker, they're able to get back devices that are substantially predicate to the intended use by saving roughly half the cost of purchasing that equivalent device," he says.


Mr. Kellar says his facilities saw increased savings over time as their reprocessing program matured.


Furthermore, reusing devices keeps them out of landfills and eliminates unnecessary waste. Mr. Liszewski says Stryker customers reduced 8.9 million pounds of waste sent to landfills last year by reprocessing their devices.

When hospitals don't need to allocate as many funds to purchasing new devices, Mr. Liszewski says they can divert that money to other clinical areas to continually improve hospital performance.


"Financial savings that can be gained by hospitals from reprocessing single-use devices can be directed toward key patient care initiatives, like hiring staff, investing in new technologies or just simply keeping a hospital afloat in difficult financial times," he says.


More articles on reprocessing:

3 tips for picking the right endoscope instrument reprocessing cleaner
Proper Endoscope Reprocessing: 5 Tips From ECRI
Medline Subsidiary Joins Association of Medical Device Reprocessors



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