MassMEDIC Supports Patient Safety Proposal; First Informed Consent Legislation in the U.S. Would Require Patients to Provide Written Consent before a Reprocessed Single Use Device is Used in Their Medical Procedure.

BOSTON -- While concerns over infections during hospital stays are on the rise, many patients are unaware that the medical devices used in their procedures may have been previously used on other patients. Single use medical devices, including those that pierce the skin or enter the body or bloodstream, are often reprocessed and used again on patients without their consent. MassMEDIC today announced its support for Senate Bill 1321 which would inform patients about the potential safety risks of reprocessed single use devices and give them the opportunity to reject the use of these devices in their medical procedures.

"Under Massachusetts law, an individual must provide consent if an aftermarket part is used in their vehicle but they are not required to provide consent if a reused medical device is used in their body," said Tom Sommer, president of MassMEDIC. "While hospitals use reprocessed devices primarily in an effort to cut costs, this savings may come at the price of jeopardizing patient safety. We believe that patients should have the right to make informed decisions about the medical care that they receive to protect themselves from unnecessary risk."

Single use medical devices (SUDs), such as surgical saw blades, angioplasty catheters and endotracheal tubes, are manufactured and designed for use on a single patient. After that they are considered medical waste. But increasingly, commercial reprocessors are cleaning and sterilizing these devices and selling them back to hospitals for reuse on patients. Since many SUDs have unique features that make them difficult to clean and provide a surface on which blood, tissue and other organic matter can accumulate, reuse of these devices can place patients at risk for contamination and infection, specialists say. In addition, reprocessing can seriously compromise the structural integrity of some SUDs, increasing the potential for injury.

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, is the first informed consent legislation in the U.S. for reprocessed SUDs. The bill requires patients to 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; requires hospitals to develop tracking systems that provide health care professionals and patients with information on reprocessed SUDs; and requires reprocessors to assume sole and complete liability for the safety and effectiveness of the reprocessed device.

A hearing for Senate Bill 1321 is taking place before the Joint Committee on Public Health on Wednesday, October 19, 2005 at 10:00 a.m. in Hearing Room A-1 of the State House. The bill is sponsored by Senator Susan C. Tucker (D-Andover) and co-sponsored by Representative John W. Scibak (D-South Hadley), Representative Joyce A. Spiliotis (D-Peabody), and Senator Steven A. Tolman (D-Brighton).

About MassMEDIC:

The Massachusetts Medical Device Industry Council, an organization of 335 manufacturers, suppliers, research institutions, and academic health centers, promotes the unique interests of the Bay State's growing and vibrant medical device sector. Through a variety of programs, informational seminars, advocacy campaigns and other projects, MassMEDIC provides medical device manufacturers and suppliers with information on industry trends and regulatory policies, and creates forums that allow members to exchange ideas and information on issues affecting the industry. For more information on MassMEDIC, please contact us at [phone], or visit our web site - www.massmedic.com.