Doctored Devices

The federal government is considering tightening regulation of companies that refurbish and re-market medical devices.

The Food and Drug Administration, which oversees the field, has noted that sales of a variety of re-marketed devices have been growing. This week, agency officials, device makers and refurbishers, and health care industry executives will meet in Reston, Va., to discuss the possibility that the agency should flex its muscles.

Mark Bruley, vice president of nonprofit ECRI, of Plymouth, Pa., studied more than 750,000 records of possible device problems over the last 20 years. He found 241 cases of adverse events such as patient injury related to certain medical devices that had been serviced, refurbished or re-marketed. Of those, 23 involved patient deaths.

Barbara Marsh covers health care for The Times. She can be reached at (714) 966-7762 and at [email protected].