By JANET MOORE
Minneapolis-St. Paul Star Tribune
March 02, 2006
None had been returned to the manufacturer - not even the 11 that were subject to safety recalls.
Maher, who owns Cremation & Trade Services Inc. in St. Paul, Minn., said he tried alerting the companies that make them but was stymied. "I kept getting transferred to different people," he said, "and then I'd end up in voice mail."
No one returned Maher's calls, and six months later, the devices sit neatly shined on a counter at his crematorium. And no one has tested them to determine if they were working properly.
As baby boomers age, the $10 billion heart-rhythm-device industry is prospering. At the same time, safety concerns are prompting more attention to how the devices are tracked and monitored.
There are no uniform guidelines for disposal of pacemakers and defibrillators after someone dies, although the Twin Cities-based manufacturers who have a virtual lock on the marketplace - Medtronic Inc., Guidant Corp. and St. Jude Medical Inc. - all say they want them returned, especially those that have been recalled.
But some heart specialists question whether the companies truly want them.
"If they get them back, then they have to go through the whole process of testing, and that's more work," said Dr. Robert Hauser, the Minneapolis cardiologist who exposed safety issues at Guidant last year. "Then there could be revelations that they'd have to report."
The companies call that speculation ludicrous.
"Are we willing to take them back? Absolutely," said Ben Khosravi, executive vice president of quality, leads development and operations at St. Jude Medical's cardiac-rhythm-management division.
In the past year, Guidant has recalled nearly 300,000 potentially faulty devices, including models that have been linked to at least seven deaths. About 87,000 Medtronic defibrillators have been recalled. And St. Jude has issued an advisory for a software problem in 39,000 defibrillators, as well.
Discovering and fixing problems in devices requires scrupulous tracking from factory floor to the operating room. Except in rare cases, manufacturers claim they can trace a product's serial number right to the patient's chest.
But once someone dies, the tracks often disappear. There is no road map to guide funeral directors and hospitals in disposing of the devices. Some do weave their way back to the manufacturer. But anecdotal evidence suggests they can end up anywhere - buried or thrown away, given to family members as mementos, or "explanted" for reuse. Often, they simply accumulate in boxes at funeral homes.
After the recent spate of recalls, a group of elite doctors formed a panel to recommend ways to track down and test faulty pacemakers and implantable defibrillators. The panel, organized by the Heart Rhythm Society, expects to issue its final report and recommendations in May.
About the size of a child's fist, the devices being studied are implanted under the collarbone and pace a heart that is beating too slowly or shock a heart that is beating too quickly.
After the Guidant recalls, which were prompted by the death of a Grand Rapids, Minn., college student whose Ventak Prizm defibrillator failed, questions arose about whether doctors and patients were adequately informed about possible safety problems in devices. Internal testing showed that the Ventak Prizm model could short-circuit, but it took Guidant three years to publicly disclose the problem.
"Clearly (the devices) should come back," to the companies, said Hauser, senior consulting cardiologist at the Minneapolis Heart Institute, who also sits on the Heart Rhythm Society's advisory panel. "They should be tested. They should be entered into the database, and any anomalies should be reported to the (U.S. Food and Drug Administration). Open-and-shut case."
But even Hauser admits that the logistics of reaching out to thousands of funeral homes and crematoriums could prove cumbersome.
Sometimes, it's difficult to find patients if there is a recall, said Tim Samsel, vice president of regulatory affairs for Medtronic's cardiac-rhythm-management division.
Medtronic was faced with this challenge last February when it issued a safety advisory for 87,000 defibrillators for a short-circuiting problem. Of that number, 19,000 devices were replaced in patients and Samsel said the "vast majority" have been returned to the company.
"In a perfect world, we would literally get every device back," he said. But despite the company's best efforts, "you do get to a point where there are a handful of patients that basically have fallen off the face of the earth."
It was a recall more than two decades ago that prompted the Food and Drug Administration (FDA) to require that companies track devices back to patients.
After 600 Bjork-Shiley heart valves failed in patients, the FDA found it difficult to alert patients about the dangers because no database existed.
"People were walking around with a heart valve that may fracture, causing a life-threatening event, and we couldn't find them," said Julie Zawisza, an FDA spokeswoman.
Today, each pacemaker and defibrillator has a unique serial number that can be traced to a patient and doctor should the device have a safety problem, and the companies characterize their registration databases as exhaustive.
But tracking the devices does not guarantee they make their way back to the manufacturer after a patient dies.
"If someone with a pacemaker dies of old age, then we don't take them out," said Stephen Remole, an electrophysiologist at Mercy and Unity Hospitals. "But if it is subject to a recall or if the death is suspicious, we send them back. I've never experienced a situation where the company did not take back a device."
If the pacemaker or a defibrillator is replaced - their batteries do run low after a number of years - it may be offered to the patient as a souvenir. On special request, Medtronic will engrave the patient's name on the explanted pacemaker or ICD.
The system for retrieving devices grows a bit muddy if a patient is cremated. Typically, the next of kin authorizes the funeral director to remove pacemakers and defibrillators prior to cremation. Otherwise, the intense heat in the cremation chamber may cause them to explode.
Sometimes a device is overlooked and ends up in the chamber. "It sounds like a shotgun going off," said Maher, the St. Paul crematorium owner, who handles cremations for funeral homes that lack such facilities. He said the explosion may cause chunks of the chamber's brick and mortar to dislodge.
Even if a device survives the process, it may still explode and injure workers handling it. "That would be like 10 firecrackers going off in your hand," said Bob Atkins, secretary-treasurer of the Arrowhead Funeral Directors Association.
Some funeral directors say they dispose of the devices as biohazardous waste. Yet others - including Maher - worry that the lithium batteries that fuel pacemakers and defibrillators may harm the environment if incinerated as biohazardous waste.
In many cases, devices simply accumulate - and sometimes they're noisy. The calm of Maher's crematorium occasionally is disrupted by a persistent beeping emanating from pacemakers and ICDs that remain functional. The sound usually indicates that the leads to the heart have been cut or that the battery is low.
When pacemakers and defibrillators are returned to a company, they are visually inspected by engineers. In Guidant's case, if the device is the subject of a safety advisory, then it will pass through a series of electrical tests outlined by a federal judge presiding over litigation resulting from the company's recalls last summer.
Dozens of lawyers with clients suing Guidant and Medtronic for various recall-related claims await the results. Currently, about 125 claims have been filed in federal court against Guidant alone.
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