February 25, 2010|By Meredith Cohn | meredith.cohn@baltsun.com
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.
