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Copyright © 2010

People, Places, Processes & Products that Influence the Supply Chain

INSIDE THE CURRENT ISSUE

March 2010

Central Services

Outpatient Connection

Study finds sutures cause fewer complications than staples in cesarean deliveries

In a study to be presented at the Society for Maternal-Fetal Medicine’s (SMFM) annual meeting, The Pregnancy Meeting, in Chicago, researchers presented findings that there were less complications for women, after having a cesarean delivery, if sutures were used instead of staples to close the wound.

Suzanne Basha, M.D. and her colleagues at the Lehigh Valley Health Network in Allentown, PA, conducted a study of 425 patients who were randomized. Women undergoing cesarean delivery in labor as well as scheduled cesarean delivery were eligible. Surgical and postpartum care was otherwise at the discretion of the provider. Wound complication data was complete for 98% of subjects (219 suture and 197 staples) and included wound separation, wound infection, antibiotic use, need for a wound-related physician visit, and readmission. Data were collected via telephone interview two to four weeks postoperatively by a single investigator.

Maternal demographic data was similar in both groups. Use of staples resulted in a higher wound separation rate (16.8 v. 4.6%, p< 0.001), higher composite wound complication rate (21.8 v. 9.1%, p< 0.001), and increased post-operative physician visits (36.0 v. 10.6%, p< 0.001); these associations persisted after adjusted analysis. Staple closure was associated with a more than four-fold increased risk of wound separation (adjusted OR 4.66, 95%CI 2.07, 10.52, p< 0.001). Median operative time was eight minutes shorter in the staple group (49 vs. 57 min p< 0.0001).

Heart patients using herbal remedies may be at risk of dangerous drug interactions

Many of today’s popular herbal supplements, including St. John’s wort, gingko biloba, garlic and even grapefruit juice can pose serious risks to people who are taking medications for heart disease, according to a review article published in the February, 9, 2010, issue of the Journal of the American College of Cardiology. The use of these products is especially concerning among elderly patients who typically have co-morbidities, take multiple medications and are already at greater risk of bleeding, according to authors.

In addition to their direct effects on body function, these herbs can interact with medications used to treat heart disease, either reducing their effectiveness or increasing their potency, which may lead to bleeding or a greater risk for serious cardiac arrhythmias.

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Budget- and eco-savvy hospitals boost reprocessing compliance

by Julie E. Williamson

Re-manufactured devices must go through FDA approvals to make sure that they are restored and identical to a brand new single-use-device. The money and resources saved by hospitals that use these re-manufactured devices is significant.

As more hospitals aim to stop the fiscal bleeding from soaring healthcare delivery and supply costs and a lingering recession and, at the same time, demonstrate their commitment to environmental stewardship, it should come as little surprise that single-use device reprocessing is playing a larger role in their efforts.

Although the third party reprocessing segment has experienced steady growth ever since the Food and Drug Administration began more stringently regulating the practice nearly a decade ago, sources agree that the practice has gained even more momentum in recent years.

"No doubt, the bad economy, coupled with discussions in Washington about healthcare reform, has contributed to the growth of reprocessing," explained Dan Vukelich, president of the Association for Medical Device Reprocessors, Washington.

Both Ascent Healthcare Solutions and SterilMed Inc., the nation’s two predominant reprocessing firms, confirmed that interest in and use of remanufactured devices among hospitals has grown rapidly over the past few years. It’s a trend that’s expected to continue – and one the companies are attributing to several key factors: an increased awareness of the safety and efficacy of reprocessing; more stringent federal oversight of the industry; and reprocessing’s ability to help facilities cut costs and leverage the supply chain for maximum savings, while simultaneously having a positive effect on the environment.

"Market demand for remanufactured devices is on the rise because of the increased focus on hospital economics and how to optimize the use of scarce resources in healthcare," Ascent told Healthcare Purchasing News. "More and more, hospitals are pursuing remanufacturing as an impactful savings strategy, and hospitals that are currently working with reprocessing/remanufacturing partners are increasing their commitment dramatically." So much so, in fact, that reprocessing ranks among the top five priorities in some of the more progressive hospital systems, according to Ascent.

Compliance kicks in

SterilMed uses microscopic analysis to ensure effective reprocessing.

Now that many concerns regarding reprocessing have waned and the practice’s benefits have become more widely recognized, the question has shifted from "Which hospitals are reprocessing?" to "How much are they reprocessing?"

"I’d say the biggest news today regarding reprocessing is the big uptick in hospital compliance. They’re now realizing that a reprocessing program won’t be effective if [staff members] aren’t doing a good job of putting products in the bin to reprocess," said Vukelich.

While each healthcare organization is unique and some facilities still only reprocess a relatively small range of devices, industry experts agree that, overall, facilities that are currently embracing the practice are looking to broaden their reprocessing efforts even further.

"Since reprocessing has become more widely embraced, the interest in using a wider range of reprocessed devices has increased," said SterilMed’s president and CEO, Brian Sullivan. He noted that in the past two years, especially, SterilMed has seen an increase in demand for higher service levels. "The penetration within hospitals already reprocessing will continue to increase."

Certainly, the financial pay-off associated with far-reaching reprocessing efforts is great. SterilMed has increased current customers’ savings 15 percent annually over the past five years, and those facilities that fully embrace the company’s reprocessing program will increase their savings 71 percent, on average, he said.

Ascent reported that while annual savings of $300,000 is a reasonable expectation for many facilities, some of its customers save more than $600,000 each year. All total, Ascent saved its healthcare partners more than $170 million through reprocessing in 2009 alone.

The cleaning process for re-manufactured devices is rigorous, and providers such as Ascent Healthcare Solutions have engineered special device-specific machines that can safely dismantle devices, such as an arthroscopic shaver (above), for cleaning.

The ever-expanding list of SUDs able to be reprocessed/remanufactured is making it easier than ever for facilities to push their savings higher. Ascent recently added the SoundStar to its electrophysiology product portfolio, and just months ago, the Gyrus was added to increase Ascent’s reprocessing programs in operating rooms. Two recent additions to SterilMed’s product offering include the Masimo pulse oximeter sensors and circular mapping catheters, including the St. Jude Reflexion, Daig Spiral and Biosense Webster Lasso catheters.

"SterilMed is currently researching Class I and Class II single-use devices to add
to the 12,000 devices that we currently reprocess," added Sullivan.

Other notable changes have come from the original equipment manufacturer side. Although a number of OEMs continue to attack the concept of reprocessing, the December news of Stryker Corp.’s acquisition of Ascent was a clear reminder that some medical equipment companies are viewing the practice as a valuable service to customers.

"The acquisition of Ascent Healthcare Solutions will enhance our value proposition by offering our customers one of the most impactful programs in use at hospitals, allowing for significant costs savings to the healthcare system," said Stryker CEO Stephen P. MacMillan, in the December 31, 2009, press release. "With Ascent as part of Stryker, we will also help divert thousands of pounds of medical waste from landfills while simultaneously redirecting substantial financial resources to patient care quality initiatives."

Ascent executives added that there is a growing sense that OEMs must strike a balance between new equipment sales and cost saving initiatives, such as reprocessing.

Still, healthcare customers shouldn’t automatically assume that more OEMs will board the bandwagon – at least not any time soon.

SterilMed uses product specific testing to ensure functionality.

"OEMs will continue to attack the concept of reprocessing because it reduces their sales of new devices and overall profits," reasoned Sullivan. "We do not expect significant changes in the near future. In order to combat this practice, we will continue to develop scientific evidence that will satisfy clinicians and staff, and promote the benefits of all levels in the hospital. Facilities that are aware of [reprocessing’s benefits] are less likely to react to OEM interference."

AMDR is doing its part to educate the healthcare community about reprocessing and clear up any lingering misconceptions about the practice. The association is revamping its website (www.amdr.org) to provide a more comprehensive resource solution to those interested in learning the facts about reprocessing and maximizing their efforts. An online blog is also in the works, and will provide a forum for those interested in reprocessing to gain vendor neutral information on the industry.

"We intend to promote environmentalism more, and provide helpful advice for hospitals wanting to promote and protect their reprocessing programs," noted Vukelich, adding that the new site will be geared toward clinical users who want to obtain links to unbiased information on the legal and regulatory history of the industry, its safety record, and ways to research how other clinical users have supported reprocessing to reduce costs and waste.

A deeper shade of green

Re-manufacturing of medical devices helps hospitals optimize resources. Above, a technician sorts parts during reprocessing of an arthroscopic shaver.

Saving on supply costs isn’t the only factor behind facilities’ desire to adopt and implement a comprehensive SUD reprocessing program. More than ever, it’s facilities’ interest in protecting the environment that is leading the charge.

"The issue of sustainability has become more and more important in recent years. Hospitals and other healthcare organizations are now making a more substantial, coordinated effort in this area," Ascent executives noted. "Sustainability coordinators and green teams increasingly have their say in purchasing decisions and in formulating policies for hospital employees. This more recent development has meant a surge in the call for usage of reprocessed and remanufactured products."

No question, reprocessing can have a significant and immediate impact on the environment by substantially reducing the amount of medical waste put into landfills, as well as the consumption of ozone-depleting petroleum-based products.

SterilMed’s new GreenMed Device Recycling Program, offered at no additional cost, allows facilities to become more environmentally responsible and effective in reducing waste disposal costs. "Given that typical disposal costs for the OR are reduced by 70 percent or more, we expect to see more and more facilities taking advantage of the GreenMed program in the future," revealed Sullivan.

Environmental stewardship was the key driving force behind one prominent, 41-facility healthcare organization’s decision to embrace reprocessing. Catholic Healthcare West began reprocessing in 1998 and has steadily stepped up its reprocessing efforts ever since. The organization, an Ascent customer, continually looks for new opportunities to expand its reprocessing program and, after having measurable success across all device segments, has recently moved more aggressively into the surgical device arena, according to Denise Robson, RN, MBA, CHW’s surgical services administrator. The organization sets savings and sustainability targets and keeps a keen eye on the program’s impact via monthly data monitoring.

"We have been hitting our targets for months," Robson raved. The organization’s impact is indeed impressive. In 2009, CHW’s 41 hospitals collectively saved approximately $6 million in supply costs and diverted 160,000 pounds of waste that would have otherwise ended up in a landfill.

It’s that hard data that will likely continue to push reprocessing up higher on the list of healthcare organization’s priorities moving forward – and, ultimately, debunk the myth that sustainability, quality and cost savings are mutually exclusive goals.

As Ascent explained, "While many sustainability initiatives are costly, reprocessing is a unique solution that simultaneously saves money while improving environmental responsibility."