Recycling may help cut down on waste, but a powerful Maryland state senator believes it could be too risky for the operating room.
Sen. Thomas L. Bromwell, chairman of the Finance Committee, has taken aim at a quietly growing practice by hospitals and doctors of re-using disposable medical devices.
The Baltimore County Democrat has introduced a bill, scheduled for a hearing today in Annapolis, that would forbid hospitals and clinics in Maryland from re-using so-called "single-use" devices unless they first notify patients and get their signed consent. Failure to do so could yield a fine of up to $10,000 per violation.
In the interests of curbing health care costs and reducing medical waste, many clinics and hospitals routinely recycle everything from surgical clamps and forceps to biopsy needles and the tiny angioplasty balloons inserted in heart patients' arteries to clean out potentially life-threatening blockages.
"These devices are labeled for one-time use only for a very good reason," Bromwell said in a statement prepared for the hearing. "That reason is that there is no scientific proof they can be sterilized and reused safely."
Spokesmen for hospitals and for companies that reprocess medical devices counter that there's no evidence patients are at risk from the practice. They contend that Bromwell's bill is an unnecessary overreaction to national news reports of recycled heart catheters breaking off after being inserted in patients.
"This is a nationwide, industrywide issue that ought to be addressed that way -- at the federal level," said Richard P. Kidwell, managing attorney for claims and litigation for the Johns Hopkins Health System.
At least one in three hospitals nationwide reuses some devices, Bromwell said, and the practice has spawned a $20 million reprocessing industry of loosely regulated companies that clean and sterilize equipment for medical facilities.
"Everybody does it," asserted Jay Schwartz, a lobbyist for the medical device reprocessing industry.
Few hospitals or doctors are willing to discuss the issue, and it's unclear how many single-use medical devices are reused in Maryland.
Pegeen Townsend, lobbyist for the Maryland Hospital Association, could not identify which hospitals recycle, but said, "We've been surprised by how much is not going on."
Hopkins reuses certain catheters in its cardiovascular diagnostic laboratory, as well as laser tips in its Wilmer Eye Institute. Recycling such devices saves about $2,000 per procedure, Kidwell estimated, which Hopkins passes on to patients and their insurance companies. All device reuse is subject to a strict internal review for safety, he added.
The Food and Drug Administration, which regulates the safety of medical devices, is moving to tighten federal oversight, even as Congress mulls legislation to require a crackdown.
"We have no data to indicate people are being injured" by the practice, FDA spokeswoman Sharon Snider said yesterday. Only 245 of 300,000 reports of serious device malfunctions received by the agency in the past three years could be tied to reuse of disposable equipment, she said.
Still, FDA officials acknowledge that they need to get a better handle on the practice and what, if any, risks it poses for patients. The agency this week proposed demanding stricter proof of safety for reusing devices it deems difficult to clean and sterilize, such as balloon catheters.
Bromwell said he sees no reason to wait for federal action, which may or may not be forthcoming. "We in Maryland have always been on the cutting edge" in health care issues, he noted.
Hospital and reprocessor lobbyists oppose Bromwell's call for getting patient consent, arguing that such a requirement would effectively ban a safe and cost-effective practice.
"It in effect indicates there's something wrong with this," Schwartz said. "There's no evidence."
The battle is over economics, not safety, contends the reprocessing industry lobbyist. In an attempt to boost sales, manufacturers have been arbitrarily labeling many medical devices for one-time use, even though they had been routinely reused in the past. Reprocessed devices must pass stricter quality reviews than when the item was originally manufactured, Schwartz contended.
Bromwell, who underwent a heart catheterization a year ago, says his bill gives patients the right to choose.