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.