ANNAPOLIS – Curbside recycling and phone book collection points are becoming more common, but medical device reuse is one recycling program that may come as a surprise, especially because many of the devices are labeled “For single-use only.”
Sen. Thomas Bromwell, D-Baltimore, wants to make sure patients know the medical devices hospitals may use on them may have been sterilized and used repeatedly despite single-use labels.
Angioplasty balloons, heart catheters, biopsy forceps, and many other devices are commonly used on more than one patient.
Bromwell’s bill would require hospitals to get patients’ written consent before reusing such devices. Upon admission, the hospital would have to provide its written medical device reuse policy to each patient, describing the potential risks of reusing them, the bill says.
“We hope it’s going to stop the reprocessing of single-use devices,” said Bromwell aide Eileen Hainey. “If a patient is give the choice of getting a new device or a reused one, what do you think they’re going to say?”
Though the practice began in the 1970s, the reprocessing of medical devices has just come to the public’s attention. Bromwell learned of the practice from recent media reports, which included criticism of the practice, including the possibility of increased risk of infection or device failure. A U.S. News & World Report article said single-use medical devices are reused as a cost-saving measure because of pressure from insurers.
The Health Industry Manufacturers Association, which represents 700 manufacturers of health care products, has opposed the reuse of devices designed or labeled for single use because of concerns for patient protection and product safety.
Supporters say devices are perfectly safe to reuse once they are sterilized, and manufacturers affix “single-use only” labels to make more money. They can sell more devices if each is only used once.
“These devices have never been tested for multiple use. They’re not approved by the FDA for multiple use and that’s dangerous,” Hainey said. “The resterilization process exposes them to high temperatures and caustic agents, and these devices aren’t necessarily safe anymore.”
There are no federal regulations governing the reprocessing of medical devices. The American Hospital Association advised member hospitals in 1997 to develop guidelines on patient consent to the reuse of used devices. The Food and Drug Administration has proposed new guidelines on reusing medical instruments to protect the public health and will hold a public hearing Dec. 14.
The proposed guidelines would allow the FDA to strictly regulate the reprocessing industry.
In the past, the FDA has issued warning letters to third-party reprocessors for violations such as failure to comply with quality systems requirements, including failure to validate sterilization procedures; failure to label devices as used; and failure to provide adequate directions for use. The FDA chose not to take action against those companies, according to the agency’s website.
Not every hospital reuses medical devices. St. Agnes Hospital in Catonsville doesn’t because it says it would be too complicated. The hospital would have to establish committees to examine reprocessing, a system would have to be created to make sure devices aren’t dangerous to patients, and guidelines would have to be developed to get patient consent.
“It is cost ineffective to do it, and patients have got enough anxiety without worrying about that,” said Laurie Davis, St. Agnes director of supplies, processing and distribution. Johns Hopkins Hospital does reuse some devices in its ophthalmology and cardiology departments, said spokeswomen Karen Infeld. “While hospital management recognizes the need to make the most efficient use of certain medical products, patient safety is the top priority that will not be compromised,” Infeld said. Johns Hopkins Hospital has created a task force to monitor FDA discussions on the issue and make sure the hospital’s policy complies with FDA recommendations. -30-