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Hospitals weigh safety, sustainability when reprocessing single-use devices

By: Gayle S. Putrich

May 31, 2013

WALTHAM, MASS. — Hospitals have been open about the increasing pressure to balance skyrocketing health-care costs with safety and sustainability. Recycling everything under a health-care facility's roof — from thin-film packaging to polystyrene cafeteria plates to medical devices — has become one way of saving money and showing patients hospitals are as concerned about the environment and consumption as they are about saving lives.

But industry veteran Len Czuba of Czuba Enterprises Inc., a Chicago-based product design and development firm that specializes in plastics engineering for medical devices, took a strong position against the quietly growing trend of reprocessing single-use medical devices.

"We're being asked to cut to the bone on the materials that we use, to minimize the design, to reduce the packaging, and yet every one of these things even further reduce the margin of safety of these devices," he said at the Plastics in Medical Devices conference, held May 13-15 in Waltham. "And it concerns me that [the Food and Drug Administration] or anybody is considering the reprocessing of single-use devices."

Czuba also expressed concern about cost-saving projects like the Healthier Hospitals Initiative (HHI) and its related membership group Practice Greenhealth. Such groups might be promoting a double standard by encouraging hospitals to phase out PVC and other materials because of the perceived dangers of chemical exposure, while at the same time encouraging hospitals to save money by striking deals for reprocessed medical devices when those items could also seriously harm patients.

The same precautionary principal is not being applied to devices as it is to chemicals, Czuba said.

Processors and OEMs should be particularly concerned, Czuba said, because their careful design and material selection is all being done with only one use in mind. "And yet they go through a cleaning step which doesn't always clean them. They go through a sterilization process, but we know that if it's not clean, you can't always guarantee sterility," he said.

"The sterilization step is a very aggressive exposure step, so manufacturers that design single-use devices very carefully select materials."

Janet Brown, director of content and outreach for HHI and a presenter and panelist at the conference, countered that there have been no clinical studies showing patients have been harmed by reprocessed medical devices and that the FDA regulates the entire process.

In a follow-up discussion after the conference, Lara Sutherland, director of business membership with Practice Greenhealth, said that while Czuba and others may have concerns about reprocessed medical devices, the reprocessing companies are just as heavily regulated by the FDA as the original manufacturers and that HHI and Practice Greenhealth support efforts to reduce waste coming out of U.S. hospitals.

"It's not something they are doing in the hospital's sterilization room," Sutherland said. "There are clean rooms and an FDA-approved process at companies that specialize in this."

She also said that part of the reason the FDA stepped in and created a regulatory avenue for reprocessing devices was that as long as 20 years ago, hospitals were attempting to reprocess devices on their own, potentially not meeting necessary cleanliness and sterilizations standards.

Striking deals with companies to remove devices that can be cleaned, sterilized and reused and bring back reprocessed devices can be a big money-saver for hospitals. HHI program participants or any hospital can select as many or as few reprocessing programs as they want, based on individual devices or even the desires of individual surgeons, Sutherland said.

At the conference, Brown stressed that medical-device manufacturers and hospitals need to work together to move toward plastics that are more easily recycled overall and fight off the perceived risk of recycling medical plastic.

"Health-care providers have to take responsibility for what we buy and what we do with it when we're done," she said. The plastics and medical-device industries can make it easier on the overwhelmed hospitals with more transparency and better labeling so administrators know what they are buying, and if and how it should be recycled.

"I still think we have a long way to go," HHI's Brown said. "What we'd rather do is prevent waste and look for opportunities to reuse rather than just send to the landfills."