Resale of Pacemakers Could Indicate Regulatory Lapses
The Sacramento Bee on Friday examined how the alleged theft of four pacemakers from a Sacramento hospital and the subsequent sale of two on an Internet auction site has "exposed a potentially fatal flaw in the nation's system for tracking lifesaving medical devices."
A former Sutter Memorial Hospital nursing attendant allegedly stole four $6,000 pacemakers from the hospital's supply closet and sold at least two on the Web site eBay for about $200 each. Under state law, all devices labeled by FDA for use only by doctors -- such as pacemakers -- may be sold only by licensed distributors. FDA also requires that pacemakers and other implantable medical devices bear serial numbers, which a salesperson registers with the manufacturer for tracking purposes.
When a pacemaker is implanted, a sales representative from the manufacturer must be present in the operating room to calibrate the electrical current in the pacemaker as a surgeon connects it.
According to the Bee, FDA officials "are not sure it is illegal to buy pacemakers on eBay."
FDA spokesperson Brad Stone said federal regulators have begun working with medical device makers to improve security and tracking.
Since the theft, Sutter Memorial has implemented policy changes that require periodic audits of supplies and eventually will require hospital staff to carry security cards and pass codes to access medical supply rooms. Under the policy, implantable device sales representatives will continue to register pacemakers' serial numbers with the manufacturer at the time of surgery.
Robert Schott, a surgeon with Northern California Cardiology Associates, said, "I am outraged that any doctor could get a pacemaker off eBay and put it in a patient. If this is not against the law, then we need to write new laws."
Spokespersons for the California Medical Board, the Department of Health Services and the Board of Pharmacy said their agencies are not responsible for tracking the sale of medical devices.
Pharmacy board spokesperson Patty Harris called such regulation a "gray area."
EBay spokesperson Hani Durzy said the company makes efforts to patrol the site and remove postings for illegal transactions. However, he called the laws for medical devices "murky." Durzy added that eBay directs all medical device sellers to verify they are dealing with a licensed buyer before they ship the item (Sacramento Bee, 3/11).