Not surprisingly, cost-containment strategies that promise significant and almost immediate savings, without the need to invest initial capital outlay, are particularly alluring to today’s cash-strapped facilities. That’s a primary reason why reprocessing of single-use devices is gaining an even stronger foothold in American hospitals, according to industry insiders.

Indeed, the practice, which generated significant controversy over the years because of perceived patient safety risks, is becoming increasingly commonplace as healthcare organizations witness firsthand the savings and proven safety that can come from reprocessing.

"The tide has definitely changed. We’ve gone from reprocessing being a patient safety issue to it now being perceived as a logical solution for reducing costs and assisting [facilities] with their sustainability efforts," noted Lory Olsson, director of field operations for Association of Medical Device Reprocessors, Washington.

To be clear, hospitals’ push for stronger economic and ecologic returns in no way suggests that patient safety isn’t still their primary driving factor when embarking upon or expanding their reprocessing programs. The difference, Olsson explained, is that customers have become increasingly comfortable with the practice since it came under stringent regulatory scrutiny and oversight by the U.S. Food and Drug Administration.

Imaging catheter testing

Now that third party reprocessing firms are held to the same (or higher) standards as the original device manufacturers, she said "There’s a real sense of confidence with the patient safety piece now."

Widely publicized reports – such as those from the General Accounting Office that stated that reprocessed devices pose no additional patient safety risks than those from the OEM – have helped reprocessing gain more widespread acceptance among hospital executives and end users, Olsson added.

At this point, it’s safe to say that using reprocessed/remanufactured medical devices has become the norm rather than the exception for U.S. hospitals. According to the AMDR, the majority of top teaching and research facilities are embracing reprocessing programs through third party reprocessors.

"Using at least some reprocessed devices is a standard practice in 70% of U.S. hospitals," confirmed Brian Sullivan, CEO of SterilMed Inc., Maple Grove, MN, pointing out that more than 3,000 hospitals (including more than 93% of the US News’ "Honor Roll" hospitals) currently have a reprocessing program.

"At a time when most medical device manufacturers are seeing reduced or slowed demand for their products, reprocessing has continued to grow at a rapid rate," he said.

That trend is likely to continue as healthcare organizations struggle to maintain a healthy financial bottom line and also look to boost their environmental awareness and gain a competitive advantage by reducing their waste stream and minimizing their carbon footprint.

In-process quality control inspection of orthopedic blades

"We are definitely seeing a different sense of urgency now than we have in the past. Our hospital partners are looking aggressively at where they can see the biggest impact on their bottom line, without the need for capital investment," said Lars Thording, senior director of marketing, Ascent Healthcare, Phoenix, AZ. More than ever, hospitals are also looking at reprocessing from a broader agenda, he noted, adding that material managers and C-level executives are also now seeing reprocessing as a unique and viable sustainability program.

Lakeland Regional Medical Center, an Ascent Healthcare customer that first introduced reprocessing in 1997, is one such facility that’s realizing firsthand how the practice is impacting the environment – as well as the bottom line.

"In the beginning, it was all about cost savings, but now it’s more about being responsible in our use of resources," noted Victor Rodriguez, director of materials management/purchasing at LRMC. "We’ve learned a lot over the years about what it means to be a leader in our home community, as well as in the medical community. We realize that our impact on the environment plays a part in that as well. Reprocessing and remanufacturing allow us to divert tons of medical waste away from landfills, and also gives us the ability to reduce the cost of healthcare so that we can deliver better care with [fewer] resources to more people."

Trocar Inspection

Olsson believes the perception of reprocessing has evolved to the point that the practice could find a receptive audience from policy-makers who could recommend it as a component of overall healthcare reform. As for eco-focused initiatives, reprocessing has already gotten the thumbs up from groups like Practice Greenhealth (formerly Hospitals for Healthy Environment, or H2E). In fact, the Arlington, VA-based organization lists medical device reprocessing as a best practice under its recommended strategies for reducing regulated medical waste.

"The use and waste associated with SUDs has been scrutinized as hospitals look to improve their environmental performance," reports Practice Greenhealth, noting that SUD reprocessing can reduce the amount of waste that it sends out as medical waste and to the landfill, both in terms of product and packaging. "All AMDR reprocessors bring devices back to facilities in reusable totes, eliminating the excess packaging from paper and cardboard that new products bring in. Paper and cardboard make up more than 50% of the waste generated by hospitals. One multi-hospital system eliminated six tons of medical waste that would have been shipped to a landfill."

Not surprisingly, the top performing hospitals – from both an economic and sustainability perspective — are those that apply the practice more broadly.

Both Ascent and SterilMed consider the operating room among the best reprocessing opportunities for the highest rate of return. Laparoscopic devices, such as trocars, ultrasonic scalpels, multi-clip appliers and other devices can, conservatively, garner savings of a hundred thousand dollars or more for a typical 200-bed hospital.

"External fixation devices used in trauma cases and in bone-lengthening procedures, while not used at all hospitals, represent a large potential savings for facilities that use them," said Sullivan. Often removed at both the hospital and the surgeon’s office, he said these devices can generate roughly $150,000 in savings annually at a Level 1 trauma center. Orthopedic surgical devices also offer significant savings, he added.

Outside the OR, hospitals will also find significant opportunity in electrophysiology catheterization labs. Sullivan noted that EP and imaging catheters alone offer a savings potential in excess of $150,000 annually.

"Years ago, many hospitals used to reprocess EP catheters and external fixation devices at their facilities. When the FDA began regulating reprocessing, hospitals were forced to discontinue the practice," he explained. "Third party reprocessors now provide that same service to again reprocess these high-cost devices. Because EP catheters and cables are used in a defined location in the hospital, they offer a great opportunity to initiate a targeted effort to reprocess these devices." He said the same is true of external fixation devices.

R&D validation testing

For Lakeland (FL) Regional Medical Center, expanding its reprocessing efforts to the cath lab is expected to generate nearly $100,000 in freed resources. Another Ascent Healthcare customer, University of Kentucky Chandler Hospital, a 489-bed facility in Kentucky, saw its 2008 cath lab savings grow to between $13,000 and $14,000 per month.

Reprocessors are seeing more hospitals willing to take their reprocessing efforts to the next level.

"In response to the economic situation, we’re absolutely seeing hospitals that had been dormant altogether now getting involved in reprocessing, and others that had been focusing their efforts on non-invasive devices first, such as BP sleeves, now looking to expand their programs," Thording noted. It’s not uncommon for facilities that are new to reprocessing to get their feet wet with non-invasive devices, such as pulse oximeter sensors, tourniquet cuffs and compression sleeves. It’s a good way for facilities to become more comfortable with reprocessing – and even then, the savings can be significant, assured Thording.

Some have found that savings generated by reprocessing can go a long way toward boosting healthcare quality and patient safety. LRMC shifted its reprocessing focus from number of dollars saved to the monetary impact those dollars make on hiring additional medical staff. Last year alone, LRMC saved nearly $300,000 on reprocessing and remanufacturing, which translated to five full-time nursing positions.

Certainly, clinical support is helping pave the way for more far-reaching reprocessing programs. Aside from earning support from C-level executives, UK Chandler Hospital has seen resistance from surgeons (even orthopedic surgeons who had been very committed to original devices) start to wane. In fact, today, reprocessed devices are used in the OR whenever possible, without question, according to Lorra Miracle, UK Chandler Hospital’s director of value analysis, who served as a registered nurse for 25 years and brought Ascent Healthcare Solutions (then Alliance) on board in 1999 upon assuming her current role.

A dedicated ad hoc committee of risk managers, quality staff, purchasing professionals and end users -- whose role is to carefully review the various aspects of a reprocessing/remanufacturing program – played an important role in ensuring acceptance from UK Chandler Hospital’s key medical staff.

While the Kentucky hospital is already reaping significant financial rewards, it recognizes even more savings potential remains.