From humble beginnings as one of the industry’s worst-kept secrets, reprocessing of single-use devices has gone legit. So legit, in fact, that much of it today is performed by third-party companies that specialize in it. And is there any greater badge of legitimacy than GPO contracts, which the reprocessors enjoy?
Companies such as SterilMed, Ascent Healthcare Solutions and ReNu Medical have their systems down pat. They have to. The Food and Drug
Administration issued a set of reprocessing guidelines in August 2000 which essentially held them to the same standards as manufacturers. Two years later, Congress passed the Medical Device User Fee and Modernization Act, which legislated strict regulations for reprocessors. With barriers like these, it’s no surprise that what once used to be carried out clandestinely in hospital CS departments and ORs, now is performed in FDA-inspected offsite facilities.
Ascent Healthcare Solutions, Phoenix, Ariz., has reprocessed more than 50 million single-use devices for more than 1,700 hospitals. The company has more than 80 510(k)s cleared by the FDA. Although reprocessing affects a relatively small number of devices used by the typical hospital, its impact can be profound, according to Arthur Goodrich, vice president of marketing and business development. “It may be a small number [of products], but we focus on the items hospitals use a lot of, and that we prove we can actually clean and sterilize.” That includes endomechanical devices, products from the electrophysiology lab, compression sleeves and other products. “We focus on the more costly, high-volume devices that most hospitals are using,” he says.
Reprocessing is carried out in one of two Ascent facilities – one in Phoenix, one in Florida. Products are picked up by overnight delivery companies, and are returned to the hospital either by an overnight firm or by a distributor of the hospital’s choice. Ascent estimates it has reprocessed more than 50 million single-use devices since the company was founded in 1987, saving its hospital customers more than $500 million.
While companies such as Ascent and SterilMed use ethylene oxide to sterilize single-use devices, Everett, Wa.-based ReNu uses a hot-water, high-level-disinfection process. Because of that, the company focuses on products that are non-invasive and low-risk, such as compression garments, pulse oximeter probes and blood pressure cuffs.
Founded in 2000, ReNu has just 50 hospital customers. But CEO Randy Long says the company is growing well, and will continue to do so. The high-level-disinfection process is a big reason why. “I’m excited about the growth opportunity in place for us, because our method and the environmental impact we can have on the marketplace are significant. Our processes are completely non-toxic. We consider ourselves the greenest reprocessor.” And because the company stays away from ethylene oxide sterilization, it can reprocess items as many as 10 times before they must be discarded.
Long says that ReNu can save a 350-bed hospital as much as $200,000 a year. Components of the cost-saving include:
- Lower waste-disposal costs.
- Avoidance of the need to replace single-use devices after just one use.
- Some reduction in-hospital reprocessing time and resources.