Hospital Buyer

Heart Rhythm Society is a professional group representing cardiac pacing and cardiac electrophysiology in North America, with a membership of about 3,500 physicians in these specialties. In the wake of the problems with ICDs from Guidant and others, the association is releasing draft recommendations (pdf) that it hopes will guide the industry to re-establish trust through:

• “greater transparency in post-market surveillance analysis, and reporting of information.
• Enhanced systems to increase the return of devices to manufacturers and to improve the analysis and reporting of device performance and malfunction information.
• Cooperation among industry, the FDA, and physicians to make every effort to prevent injuries and deaths due to device malfunctions.”

Among the recommendations to the industry:

• Establish performance standards for devices and their components such as leads or batteries.
• Publish standardized device performance reports every six months against these standards.
• Publish malfunction rates by device every year based on their FDA reports.
• Identify abnormal device behavior as soon as possible by determining their functional status more frequently and accurately.

There is also advice for doctors and the FDA as the Society is trying to kick off a system-wide effort. The term recall for instance, is deemed inappropriate because it can be wrongly interpreted by doctors and patients as meaning devices need to be replaced even though it’s not always the case.

April 26, 2006 Related topics: Medical Devices & Products, Cardiology