FDAnews Device Daily Bulletin


July 12, 2006

A bill under consideration in the Massachusetts state legislature offers patients the option of giving their informed consent before being treated with reused, or "reprocessed," devices designed for single use only.

The Massachusetts Medical Device Industry Council (MassMEDIC) says more rigorous state legislation will force hospitals to inform patients when single-use devices (SUDs) are being used again and give patients the option of refusing treatment with those devices.

The Massachusetts Senate's Joint Legislative Committee on Health Care Financing June 27 reviewed information related to S.B. 1321, "An Act Relative to a Patient's Right to Know of the Reuse of Certain Medical Devices Manufactured for Single Use."

The current bill would require:

A patient to provide written consent prior to undergoing a procedure involving a reprocessed SUD that pierces the skin or that enters the body or bloodstream;

Hospitals to develop tracking systems that provide healthcare professionals and patients information on reprocessed SUDs; and Reprocessors to assume sole and complete liability for the safety and effectiveness of the reprocessed device.