In a bid to reduce waste and control costs, a growing number of U.S. hospitals are now cleaning and reusing tools such as compression sleeves, laparoscopic ports, and other medical and surgical items labeled for one-time use.
Hospital administrators had been behind the move, called reprocessing, but more recently it's been fueled by environmentally minded workers looking to change the health care industry's status as one of the largest contributors to the nation's landfills. Tons of equipment are tossed every year after being used once, according to some participating hospitals.
About a quarter of the nation's hospitals now do some reprocessing, according to Dr. Martin A. Makary, a surgeon and associate professor of public health at the Johns Hopkins University School of Medicine who has studied the trend.
There is still some opposition from patient advocates and manufacturers who are concerned about safety, despite successful pushes for tougher regulation by the U.S. Food and Drug Administration. A recent Government Accountability Office study concluded the process was safe, though officials acknowledge there isn't much research on the nascent industry.
"Hospitals are taking incremental steps," said Makary, who joined well-known Hopkins safety expert Dr. Peter J. Pronovost in an analysis of reprocessing to be published in the March issue of the journal Academic Medicine. "The opportunities are almost endless."
Makary, who also directs the Johns Hopkins Center for Green Health, said he has visited FDA-approved reprocessing facilities to examine how the equipment is cleaned and recalibrated. The FDA allows about 100 items to be reprocessed, though a few items are the most common, including the compression sleeves and pulse oximeters, which fit on the fingertip and test oxygen levels and heart rates.
But Michael Bennett, president of the Coalition for Patients' Rights in Maryland, said hospitals shouldn't take chances with reprocessing. If they want to reuse equipment, they should find vendors that will sell them durable equipment, rather than items labeled for single use, he said.
"It is unconscionable for a health care worker or an institution to subject an unsuspecting and uninformed patient to unnecessary risk just to save a few dollars," Bennett said. "While there very well may be manufacture or sales self-interest in the 'single use' classification of some devices, would anyone be willing to use a possibly safety-compromised parachute? There are plenty of other areas in health care where money can be saved without jeopardizing patient safety, such as better infection control and fewer errors."
Reusing equipment isn't new. Hospitals used to routinely clean and reuse their own items, but fears about the cleaning abilities of individual facilities led manufacturers to beginselling single-use devices, said Makary. He estimates those items now make up about 15 percent of what hospitals use.
The devices became increasingly sophisticated and costly, pushing hospitals back in the other direction, he said. That FDA regulation also led nearly all hospitals to send the equipment to third-party reprocessors, who sell items back to hospitals for about half the cost of new ones.
Hopkins is now only sending equipment to reprocessors but not buying it back, though officials say they plan to. Savings on waste disposal so far are minimal. However, at the University of Maryland Medical Center, where officials have been buying some reprocessed items for more than a year, the savings have been about $400,000.
The center is proceeding cautiously, for now only buying noninvasive reprocessed devices such as blood pressure cuffs, though officials are exploring more types of equipment, said Denise Choiniere, Maryland's sustainability manager and a registered nurse. She said officials have been visiting reprocessing facilities.
She said the push for reprocessing came from workers who recycle at home and didn't understand why they had to throw away so much equipment, particularly so much that was never used. Items are sometimes dropped or the packaging is opened.
"Safety is No. 1, and we need to make sure there are quality checks in place and what they're sending back is the same quality as new devices," she said. "But it's hard to find someone who doesn't think this is a good idea."
In the past five years, business has been growing and opposition has been fading, according to Lars Thording, senior director of marketing and brand strategy for the reprocessing company Ascent Healthcare Solutions. The challenge now is to make hospital workers understand how much they can reprocess, he said.
The company has 1,900 client hospitals of all sizes, and some are saving $1 million a year, he said.
But Thording said many items that could be reprocessed are still being thrown away. Also, many items not able to be reused are sent to the company. He said workers break them down and recycle as many parts as possible, though that is not a moneymaking endeavor.
Thording said he understands some patients' groups, and even some hospital staff members, might be concerned about devices failing or spreading infections. He said each device needs clearance from the FDA to be reprocessed; the agency also regulates how and what can be reprocessed and how many times. The devices are made from durable metals and plastics.
"Our headline is 'Control, control, control,' " he said. "Everything is monitored. If our devices are not squeaky clean, it can be used as a weapon against us. You will not find anywhere an independent study that shows reliable results that reprocessed devices are not every bit as clean and safe as new ones."
But the Advanced Medical Technologies Association, a trade group for major device makers, has maintained for years that items labeled for single use aren't meant to be used again, and cleaning them might cause them to malfunction or might not fully remove debris. A spokesman said the group stands by its position.
Makary said in his analysis that many physicians and politicians have lobbied for legislation requiring written patient consent when reprocessed items are used and a stricter system of tracking failures and injuries. And in 2002, legislation required devices be labeled as reprocessed and by which company, and called for more FDA oversight, including inspections.
In 2008, a GAO report on reprocessing found seven of 10 reprocessing establishments in the previous three years had problems, but all have been corrected. The report also said that there had been 434 "adverse events" from 2003 to 2006 in which reprocessed devices were identified, but only 65 of those events were found to directly involve the device, which is about equal to new devices.
The report said FDA data and outside studies were insufficient to definitely say reprocessed devices were as safe as new devices, but said there's no indication they present an elevated health risk.
Reprocessing is growing in U.S. hospitals•Reprocessing is the cleaning and reuse of equipment labeled for one-time use.
•About 25 percent of hospitals reprocess some equipment.
•The most common devices are compression sleeves to prevent blood clots in patients' legs and pulse oximeters that fit on the fingertip and measure oxygen and heart rates.
•The FDA regulates the practice and the government deems it safe, though some patient advocates fear malfunctions or infections.