Regulatory
Original equipment manufacturers (OEMs), who make no bones about trying to abolish the reprocessing of single-use devices, have drafted a bill in Massachusetts that is making hospital officials nervous.
The OEMs’ measure, “An Act Relative to a Patient’s Right to Know of the Reuse of Certain Medical Devices Manufactured for a Single Use,” would require hospitals to obtain patients’ consent before reprocessed SUDs can be used on them.
“We are looking at this bill as both a patient safety and a patient rights issue,” says Nigel Wilkinson, vice president for regulatory affairs and quality assurance at Smith & Nephew Endoscopy, Andover, Mass., which was the source of the bill.
“We believe patients have the right to say yes or no,” says Wilkinson, whose company is a division of Smith & Nephew PLC, London.
But, the potential outcome of the bill alarms William Butler, senior director for system supply chain at UMass Memorial Health Care, a 1,100-bed system based in Worcester, Mass., which has just begun to embrace single-use device (SUD) reprocessing. Butler says the hospital is saving $200,000 a year because of it and hopes to eventually save as much as $500,000 a year.
Butler thinks device-makers have hitched their wagon to a powerful issue. “The patient consent provision makes this bill potent,” he says. When lawmakers vote on the bill, which is not expected for several months, “my gut feeling is that it will be very close,” Butler says. “There is a very strong lobbying effort from some large organizations behind this bill.”
If the measure passes and patients are asked if they want a new device or a reprocessed one, Butler thinks he knows what the answer will be.
Even though reprocessed SUDs are monitored by the FDA, Rockville, Md., and a great deal of data shows they are safe, he thinks patients will draw their own conclusions. “To explain what we’re going to do—that, from the patient’s perspective, we are giving them a used car rather than a new one—would be difficult for a patient to accept,” Butler says.
The bill requires that a hospital issue a written notice, “separate from all other documents provided to a patient,” describing “the circumstances under which such reprocessed single-use devices are used and the safeguards” for patient safety as well as a list of “potential risks.” The attending physician or a designee must discuss the notice with patients and make sure they understand it.
Wilkinson says hospitals that insist on reusing single-use devices should present their case directly to patients.
He also contends that Smith & Nephew’s arthroscopic shaver blades and arthroscopic burrs are frequently reprocessed, resulting in residual contaminates and defects such as poor cutting edges, damaged plastic, missing pieces and damaged sterile packaging.
A new assault
The Massachusetts bill, similar legislation in Utah and possibly a measure coming up soon in New Jersey represent the device industry’s latest assault on the reprocessing industry, according to the Association of Medical Device Reprocessors (AMDR), Washington, D.C. AMDR reports that the last major assault took place between 1998 and 2000, when OEMs tried a scattershot of approaches in drafting bills in four states and in Congress. A bill in Maryland and one in Congress contained provisions for patient consent for reprocessed devices, but they failed. For the past five years, OEMs have focused on persuading Congress to pass tighter regulation of reprocessors through the FDA.
As a result of bills passed by Congress in 2000, 2002 and 2005, the FDA has virtually stopped hospitals’ in-house reprocessing of SUDs, ended reprocessing of many devices that were considered dangerous and introduced new monitoring requirements. But rather than end reprocessing, FDA oversight ensured higher standards and spawned a booming third-party reprocessing industry, according to Dan Vukelich, AMDR’s deputy executive director. He reports that total revenue for AMDR members rose from $36.9 million in 2001 to $87 million in 2004.
At the state level
After a five-year absence, OEMs are back in state legislatures, focusing on patient consent. The Massachusetts and Utah bills also have had provisions requiring that hospitals to report adverse events and waiving OEM liability for reprocessed devices. But hospitals are already required to report adverse events to the FDA and the liability waiver does not directly affect hospitals.
Joe Krella, president of the Utah Hospitals and Health Systems Association, reports that the consent and reporting provisions were stripped out of the Utah bill, leaving only the liability provision when it passed in March.
But tougher battles lie ahead for reprocessing. Don Selvey, vice president for quality at Alliance Medical Corporation, a reprocessor in Phoenix, reports that Merit Medical Systems, South Jordan, Utah, the OEM behind the Utah bill, does not even produce SUDs that are reprocessed. The Massachusetts bill, on the other hand, has three major supporters, all contending with reprocessing: Smith & Nephew Endoscopy; Boston Scientific Corp., Natick. Mass.; and Bard Electrophysiology, Lowell, Mass., a division of C.R. Bard, Murray Hill, N.J. They all testified at an Oct. 19 hearing on the bill that took place in front of Massachusset’s Joint Legislative Committee on Public Health.
Also unlike Utah, Massachusetts is a stronghold of Democrat voters who see patient rights as a key issue. The bill was introduced by Democrat State Sen. Susan C. Tucker and has been co-sponsored by three other Democrat lawmakers. Tucker, whose district includes Smith & Nephew Endoscopy’s headquarters, told The Boston Globe that the company proposed the idea of legislation.
A similar fight appears to be brewing in New Jersey, another blue state that is headquarters to several major device-makers. Holly Glass, spokeswoman for C.R. Bard, says the HealthCare Institute of New Jersey, a trade association comprising device and pharmaceutical companies, may endorse a patient consent bill for reprocessing by the end of the year. She says the group is still considering its options.
Vying for public opinion
In the debate over patient consent for reprocessing, both sides are trying to win over three key constituencies: patients, surgeons and the media.
A 2002 nationwide survey by the now-defunct Center for Patient Advocacy found that two-thirds of the public said they were unaware that reprocessed devices were used by hospitals and two-thirds also expected to be informed beforehand.
Critics have called the survey biased because it was paid for by Smith & Nephew and the center, which was founded by Neil Kahanovitz, M.D., a Philadelphia orthopedic surgeon. A model consent form for reprocessed SUDs was on the center’s Web site. The center’s survey also reported that three-quarters of surgeons nationwide felt that reprocessing posed “a health and safety risk to patients.” Paul Wetzel, executive director of the Massachusetts Orthopaedic Association (MOA), says that finding does not reflect views of his members, who have “a mixed bag of attitudes” on reprocessed SUDs. In fact, MOA testified against the bill at the legislative hearing, stating that “reprocessing does not affect the quality, physical characteristics or performance of the medical device.” But findings of strong public support for patient consent cannot be easily discounted. At Bard, Glass reports that a series of focus groups and polls by the HealthCare Institute of New Jersey, Hillside, have found that “it’s pretty unanimous that consumers, at least in New Jersey, are opposed to the idea of reprocessed single-use devices.”
Back in Massachusetts, an article appeared in The Boston Globe on the day the legislative hearing took place and opened a firestorm of debate. The Globe ran photos of allegedly contaminated reprocessed devices, supplied by the OEMs. Makers says they came from hospitals that would not identify themselves because they feared legal action. The opening sentence of the article quickly established that there was a problem: “Medical-device companies say an increasing number of doctors are treating patients with improperly sterilized surgical tools, catheters, and other instruments that are contaminated with blood or bacteria.”
The story angered Christine Pouliot, R.N., operating room nurse manager at 126-bed Sturdy Memorial Hospital, Attleboro, Mass., which saves up to $60,000 a year with reprocessed SUDs. Pouliot, who opposed reprocessing until she toured a reprocessing facility and was impressed by its standards, testified against the bill at the legislative hearing.
“I saw horrible pictures,” Pouliot says. “Shame on the Globe for printing them and not knowing where these pictures came from or that they were in any way legitimate.” On the other side of the debate, Joe Metzger, a spokesman for Smith & Nephew, insists that his opposition to reprocessing is as much personal as professional.
“I would never, ever allow myself or anyone in my family to be operated on with a reprocessed device,” he says.
Leigh Page is a freelance writer based in Oak Park, Ill.
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