Massachusetts’ Reprocessing Legislation Gaining National Attention

If a bill under consideration in Massachusetts becomes law, Bay State patients will have another consent form to consider when they are admitted to the hospital or undergo medical procedures in doctors’ offices. A bill currently before the state’s senate would require that patients be informed of—and consent to—the use of any reprocessed medical device previously designated by its manufacturer as a single-use device (SUD).

The Massachusetts bill is the first legislation of its kind in the United States regarding reprocessed SUDs and is being closely watched by medtech manufacturers and hospitals across the nation.

Manufacturers, who cite safety and efficacy concerns with reprocessed SUDs, generally support the legislation. Hospitals are typically opposed since they see the use of reprocessed SUDs as an essential cost-control measure that also reduces medical waste.

Tucker: Right to know.

Massachusetts Senate Bill 1321, An Act Relative to a Patient’s Right to Know of the Reuse of Certain Medical Devices Manufactured for a Single Use, was introduced this past summer by State Senator Susan Tucker (D–Andover). According to Tucker, the original concept of the legislation was developed by Smith & Nephew plc (London), which operates a manufacturing facility within her district.

The bill has already attracted a number of supporters in both the Massachusetts Senate and House. It offers three principal stipulations regarding the use of reprocessed SUDs:

• Patients will provide written consent prior to having a reprocessed SUD that pierces the skin or that enters the body or bloodstream used in their medical procedure.

• Hospitals will develop tracking systems that provide healthcare professionals and patients with information on reprocessed SUDs.

• Reprocessors will assume sole and complete liability for the safety and effectiveness of the reprocessed device.

The proposed legislation has the support of the Massachusetts Medical Device Industry Council (MassMedic; Boston), which represents more than 300 medtech manufacturers and allied suppliers in the state. It has also received the backing of national industry associations AdvaMed (Washington, DC) and the Medical Device Manufacturers Association (MDMA; Washington, DC), the medtech industry’s leading national trade groups.

MassMedic’s Sommer: Safety over cutting costs.

Commenting on the bill, MassMedic president Thomas J. Sommer said, “ Hospital use of reprocessed devices to cut costs may come at the price of jeopardizing patient safety.” Thomas Tremble, AdvaMed’s director of government and regional affairs cited the inherent health risks of reprocessed SUDs, which he asserted could compromise a device in terms of both functionality and safety. Specifically endorsing Senate Bill 1321, Tremble said, “Patients and clinicians should have the right to know whether a medical device that has already been used on another patient will be used in their surgery or other medical care.”

In a position paper, MDMA describes SUDs as “designed for optimal single-use performance rather than ease of cleaning. Their structural integrity may be seriously compromised or destroyed by sterilization and reprocessing.” Mark Leahey, MDMA’s executive director, adds, “Apart from our primary concerns regarding safety and efficacy, we wonder what percentage—if any—of the supposed savings generated by hospital use of reprocessed SUDs is ever passed on to the consumer.”

The Association of Medical Device Reprocessors (Washington, DC), which vigorously defends the safety, efficacy, and cost-effectiveness of reprocessed SUDs, dismisses the proposed Massachusetts legislation as a “thinly veiled attempt to boost device industry profits at the expense of hospitals, patients, and the environment.”

Estimates of SUD reprocessing vary widely, but it is generally believed that the incidence is now far greater than indicated in a 2002 FDA survey, which reported that about one-quarter of all hospitals used reprocessed SUDs, increasing to almost half for larger healthcare facilities. SUDs that are typically reprocessed for reuse include compression sleeves, drill bits, saw blades, forceps, clamps, angioplasty catheters, endotracheal tubes, and endoscopic instruments.

FDA strengthened the regulations relating to reprocessed SUDs in 2000, requiring reprocessors to abide by standards, procedures, and reporting systems that are much the same as those that apply to original equipment manufacturers under the premarket notification (510(k)) rules. Under the most recent amendments to the Medical Device User Fee and Modernization Act of 2002, reprocessed SUDs must be prominently and conspicuously labeled as such and include the identification of the reprocessor. Complete information on FDA requirements regarding reprocessed SUDs can be found via the Web site of the agency’s Center for Devices and Radiological Health at www.fda.gov/cdrh/reuse.

FDA’s beefed-up requirements for reprocessed SUDs generally exceed the resources and capabilities of hospitals and have resulted in far greater use of third-party service providers, which now control a $125 million growth market for SUD reprocessing that has reportedly doubled over the last few years.

An initial hearing on the Massachusetts bill was held on October 19, with no definitive outcome. A legislative committee staff member describes further action as “pending,” although no additional hearings have yet been scheduled.

© 2005 Canon Communications LLC

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