Tread carefully when reprocessing SUDs

Reprocessing of single-use devices is becoming increasingly popular among U.S. health care organizations, which are drawn to the potential cost savings and, more recently, the effort to go green by reducing waste. But do those benefits bring liability risks?

They can if the reprocessing program isn't set up and monitored properly. But careful attention from the risk manager can keep those risks to a minimum and should not dissuade health care providers from adopting this strategy, the experts say.

Reprocessing has been around for decades and was much more controversial years ago, when no one was certain about the safety of using reprocessed instruments and the potential liability if they led to patient harm. Now much of that doubt has been cast aside, and a recent commentary in Academic Medicine received attention for calling on providers to adopt reprocessing more widely as a way to go green.1 The authors of the commentary, from the Johns Hopkins University School of Medicine in Baltimore, pointed out that more than 25% of U.S. hospitals are using reprocessing as a means of decreasing the tons of disposable waste generated annually. In 2008 alone, there was a 20% increase in hospital utilization of reprocessing services offered by one leading reprocessing service, and associated cost savings of $138,142,000 nationwide. This represented 4,300,000 pounds (2,150 tons) of medical waste diverted from local landfills, they noted.

The authors also concluded that research has shown that reprocessed medical devices do not present an increased health risk when compared with new devices, though they call for further research. (The commentary is available online at no charge. Go to http://journals.lww.com/academicmedicine/Fulltext/2010/03000/Commentary__A_Call_to_Go_Green_in_Health_Care_by.10.aspx )

The cost savings can be substantial. Ascent, a leader in the reprocessing of medical devices in the United States, based in Phoenix, announced recently that its hospital partners realized hundreds of millions of dollars in cost savings in 2009. On a per-hospital basis, some hospitals saved more than $600,000 per year. Serving 1,800 leading hospitals, Ascent tracks savings realized by its customers year-over-year, and cost savings resulting from Ascent's reprocessing programs were up more than 20% in 2009 and were up more than 50% versus 2007.

Members of the VHA health system based in Irving, TX, saved $42 million in 2009 from reprocessing, says Tina Norris, senior director of purchased services with VHA. About 600 VHA members reprocess.

Liability was a concern for VHA from the start, Norris says. Though VHA believes reprocessed instruments do not pose any risk to patients, she says it was important to structure the contract with the reprocessing vendor so that the hospital was protected if a reprocessing failure led to a claim.

"We dive into the workings and the processes of the supplier," Norris says. "We want to see that their quality assurance is at the highest level, and that they are testing each device as it is finished. We feel confident that the process our supplier uses is top notch and is safe for our members."

Norris notes that deciding to reprocess is a significant undertaking. It is not as simple as finding a reprocessing vendor and starting to send equipment out. The program must be monitored closely for quality controls, she says.

The question of patient safety has been minimized but still exists from a legal standpoint, says Angela Nolan Clarke, JD, an attorney with the law firm of McGlinchey Stafford in Houston.

"Reprocessing has been shown to be safe for patients based on what we know to date," she says. "That's where it gets tricky. If I were sitting down with a risk manager, I'd say you need to decide whether you want to do it at all. But the next question is what devices do you want to reprocess, because the challenges and the risks can be different."

There are three classes of devices that are reprocessed, and Clarke says that she advises caution with Class III items, because they have the least amount of research showing them to be safe when reprocessed.

"You'll feel more comfortable about Class I and Class II devices, but it can be a leap to reprocess Class III," she says. "You might not feel as comfortable there, and for good reason."

Many hospitals outsource the reprocessing, partly in hopes that such an arrangement would insulate the provider from liability related to the reprocessing, notes Richard Law, JD, also an attorney with McGlinchey Stafford in Houston. That probably is not the case, he says.

"It's not likely that you would be completely protected, but you would have the ability to go back after the reprocessing company and show that they were not in compliance with government regulations and meeting the standards for reprocessing," Law says.

Clarke says it is very important that a reprocessing program include an adverse event reporting process. Any adverse events that could be related to the reprocessed items must be reported and thoroughly documented, she says.

Law also points out that there has been some debate over whether to get informed consent from the patient before using a reprocessed item. Law says risk managers must decide whether patients will be asked for permission, but be prepared for many of them to decline.

"I don't think most patients would care much if you didn't say anything, but once you ask them you have to be prepared for a lot of them to say no, they want a brand new item if they have a choice. That's going to affect your cost savings in the long run," Law says.

Reference

1. Kwakye G, Pronovost PJ, Makary MA. A call to go green in health care by reprocessing medical equipment. Academic Medicine 2010; 85:398-400.