Operating Room

Confidence growing in reprocessed SUDs

by Julie E. Williamson

Once razor-sharp, concern and skepticism about the safety and efficacy of using reprocessed single-use medical devices appears to have softened in many hospitals these days. In fact, it seems that many healthcare facilities are growing increasingly confident in their use of reprocessed devices – and more specifically, the outside companies they entrust with the practice.

Given the increased oversight by the Food and Drug Administration, the more widespread acceptance of reprocessing as an alternative should come as no surprise. Healthcare organizations, many of which steered clear of the practice in the past, are now more satisfied that reprocessing is not only safe, but also a viable option for reigning in out-of-control costs.

“The FDA has given its approval and science shows that reprocessing is safe and effective when done properly. The greater oversight and tighter regulatory requirements have given hospitals more confidence to explore their options,” said Susan Klacik, sterile processing manager, Forum Health, an integrated delivery network with some 30 facilities in the Youngstown, OH, region. Klacik also serves as the International Association of Healthcare Central Service Materiel Management’s alternate representative for the influential Association for the Advancement of Medical Instrumentation (AAMI). 

Of course, the passage of time has also spurred greater, albeit gradual, acceptance, sources told Healthcare Purchasing News. Some facilities said they simply waited for the FDA and the reprocessing industry to “iron out the wrinkles,” and used that time to research their own options, brush up on the science and do the math on the potential cost savings. 

Ron Runyon, sterile processing manager at St. Vincent Hospital, a 15-facility healthcare network based in Indianapolis, said that while his facility has been using the services of a third party reprocessor for more than three years, his own confidence didn’t come until his two-year stint on a committee aimed specifically at reprocessing. 

“I admit I was against it at first,” he says. “The FDA oversight and my involvement on the committee helped change my opinion and increase my comfort level.”

Like many other hospitals, St. Vincent Hospital began by reprocessing non-invasive items, such as tourniquets and blood pressure cuffs, and has since added other devices like electrophysiology catheters.

Slow but steady adoption
Some hospitals that historically shied away from reprocessing single-use devices are now laying the foundation for changing their long-standing policies. Often, it’s those at the administrative level who initiate discussions on reprocessing, backed by various department heads who weigh in before any final decisions are made.

Such corporate-level discussions are currently underway at Intermountain Health Care, a large IDN in Salt Lake City. According to Bruce Bird, sterile processing manager at IHC Urban Central Region Hospital, the health system is relying on a multidisciplinary committee – one that consists of representatives from infection control, nursing, central service, surgical services and risk management, among others — to evaluate third party reprocessors and determine whether any can meet IHC’s stringent criteria for quality and safety. 

The healthcare organization, Bird said, initially evaluated half a dozen reprocessors before trimming the number of potential partners to three or four. A consultant has also been brought on board to help determine which reprocessor, if any, is best suited to the health system’s needs.

“We have been involved in this process for about a year. We are interested in looking at our options, but we are not interested in just jumping right in without a thorough assessment. A lot of major healthcare organizations are reprocessing, so we see that it is worth looking into. At the same time, we won’t do it just because everyone else is,” Bird noted.

Until the committee agrees on a third party reprocessor, IHC policy states that no SUD can be reprocessed.
Elsewhere, other facilities are also treading carefully on the subject. Corporate executives from one Midwestern health system decided to recruit the services of a third party reprocessor, but put on the brakes after visiting the company’s facility. According to the organization’s CS manager, the visit “raised concerns because we didn’t like what we saw with the operation.” Officials declined to provide the name of the third party outfit. Still, the negative experience hasn’t turned the health system off from reprocessing altogether. It is currently assessing other companies in hopes of beginning the practice in the near future.

When good reprocessing goes bad
Recent events on the regulatory front have incited mixed emotions. For instance, on August 7 the FDA announced it had cited reprocessor Adven Medical Inc., a reprocessor based in Lubbock, TX, for failing to adequately reprocess medical devices.

The FDA accused the small firm, which reprocesses a range of items including catheters, biopsy forceps, sutures and blood pressure cuffs, with failing to validate its cleaning, disinfecting and sterilization processes; adequately establishing and maintaining procedures to validate medical device designs; establishing and maintaining procedures to prevent and correct manufacturing problems; as well as the failure to use adequate criteria to ensure that finished devices meet their design specifications. 

According to the Aug. 7 FDA press release, Adven Medical’s history of non-compliance dates back to June 1999 when, under a partnership with the FDA, the Texas Department of Health inspected Adven’s manufacturing facility. Many of the problems observed in that initial inspection actually recurred, along with additional problems that arose in later FDA inspections. The FDA subsequently charged Adven with failure to correct these problems. In light of these findings, Adven Medical president Mark Aldana has signed a consent decree of permanent injunction in which the company agrees to halt reprocessing and distributing of medical devices until the FDA is satisfied that the company has resolved its manufacturing difficulties. 

“If firms don’t adhere to good manufacturing practice standards for reprocessing medical devices, there is no guarantee that reprocessed devices will be safe and effective,” noted FDA commissioner Mark McClellan, M.D., Ph.D., in the prepared statement.

Such strong statements may validate healthcare organizations’ concerns about the safety of reprocessing, and perhaps even make some involved in the practice question their decision. One CS director, alarmed by the news, said the developments at Adven may make her facility, which has yet to begin reprocessing, “scrutinize the practice even more.”

Others, however, welcome the FDA’s aggressive action, which they feel has clearly sent a positive – and powerful – message to the reprocessing industry. Mike Goonewardene, COO of ClearMedical Inc., a reprocessor based near Seattle in Bellevue, WA, said the FDA has shown it will stand behind its regulations to drive safe practice.
“Having the FDA exert its regulatory oversight is a good thing for hospitals and the industry because it helps ensure that safe, effective manufacturing practices are being followed and that all reprocessors are held to the same standards as the original equipment manufacturers,” he said.

Regardless of whether the citations make facilities more or less inclined to reprocess, Anne Cofiell, president of Cofiell Consulting Services, Mt. Laurel, NJ, said one thing remains certain: “The FDA is going to really keep an eye on third party reprocessors and come down very hard on them” when found in violation of the regulations. That message alone could serve to reassure hospitals that scientifically at least, the practice of reprocessing SUDs has distinct merit.

The bottom line
The ubiquitous search by hospitals for cost savings can trump the residual clinical concerns regarding reprocessing. And although the level of savings will vary significantly based on facility size, number of devices used, and most importantly, which devices the hospital chooses to reprocess, sources indicated that even moderate reprocessing can save a bundle.

In Indianapolis, SPD manager Runyon said St. Vincent Hospital saves approximately $200,000 annually on EP catheters alone through reprocessing, and a CS manager from another major health system revealed that when it finally adopts “across the board” reprocessing, annual savings may exceed $1 million. The health system currently only reprocesses a handful of items, such as EP catheters, blood pressure cuffs and finger oxisensors.
But not all facilities have been swayed by reprocessing’s promised savings. In fact, after pushing a pencil and factoring in the added responsibility, some have opted to table reprocessing indefinitely. Kootenai Medical Center, Coeur D’ Alene, ID, for example, wasn’t content with the national average savings touted by one third party operation, so the facility used the formula to plug in its own numbers.

“While reprocessing may make good financial sense for some facilities, we found that the savings we would see wouldn’t be enough to offset the risk, particularly when we factored in the [time-consuming task] of collecting and storing items that would be sent to the reprocessor,” explained Kootenai’s clinical supervisor Laurie Davis. “After careful evaluation, we finally decided that we will not reprocess any items.”

Davis, who admitted she was uncomfortable with the idea of reprocessing and relieved by administrators’ decision not to partake in the practice, nonetheless said she’ll still understand if Kootenai decides to take another look at reprocessing in the future. 

“At some point, our hospital may decide to go that route, so I am keeping an open mind,” she continued. “If that happens, I want to be absolutely comfortable with the idea. I can at least feel confident in knowing that the views of CS will be heard and all the right players will be involved in the decision-making process.”

Perhaps one of the greatest obstacles standing in the way of hospitals’ decision to pursue more widespread reprocessing isn’t skittishness on behalf of corporate executives or CS managers (although some acknowledge they aren’t exactly thrilled about taking on yet another process that must be monitored and evaluated). Instead, much of the reluctance stems from surgical professionals who have been accustomed to a certain standard of practice. Complicating matters further are ongoing efforts by OEMs to evoke fear in operating room staff by debunking the efficacy of reprocessing.

Even so, third party firms remain optimistic that they’ll continue to rise above the challenge.
“This is still a new concept for some, and no passing of a bill will automatically change everyone’s opinions,” acknowledged Arthur Goodrich, vice president of marketing and business development for Phoenix-based reprocessor Alliance Medical Corp. “This has always been a challenge, but it is becoming somewhat easier for us as an industry as more people become aware of reprocessing.”

In spite of those inherent challenges, Goodrich said hospitals that haven’t embraced reprocessing in the past are more willing than ever to adopt the practice. At the same time, many that have been reprocessing at least some items are beginning to look for ways of expanding the practice to drive more savings.

“Once a facility’s comfort level increases, it becomes easier to take reprocessing up a notch,” said Goodrich.

Runyon agreed, noting that has certainly been the case for St. Vincent Hospital. “We see that there is room to do more,” he said. “Our hospital is moving slowly and gradually adding more devices as the comfort level grows. I see that reprocessing could really save a fortune in the future.” 

HPN

October
2003