Atlanta, GA - Implantable pacemakers and cardioverter-defibrillators are rarely interrogated or returned to manufacturers postmortem, despite FDA and manufacturer policies that specifically request return of the devices for analysis, a new survey shows. Instead, devices typically get thrown away, donated to underprivileged countries, or used in pets, according to Dr James N Kirkpatrick (University of Chicago, IL), who presented the survey results in a poster at the recent American College of Cardiology 2006 Scientific Sessions.

"We were surprised to find that morticians essentially throw away devices after explantation, which was done almost only precremation, since it is well known among all morticians that devices can explode during the process and damage crematoriums, which means that most devices are actually buried with the deceased persons," Kirkpatrick told heartwire. "All morticians know how to remove the devices, but they don't know what they are supposed to do with them." 

As the investigators point out in their poster, recent recalls of implantable devices have highlighted the need for routine device analysis, particularly since the true rate of device malfunction is unknown and, while rare, can be catastrophic. While the FDA supports a policy of returning pacemakers and ICDs to manufacturers postmortem—and manufacturers' instructions explicitly request that devices be returned for interrogation—guidelines for morticians contain no special directives for what to do with the devices, Kirkpatrick and colleagues note.

In fact, Kirkpatrick said, "Several morticians mentioned that they had boxes of devices just 'sitting around the shop.' "

When the device lives on

In the autumn of 2005, Kirkpatrick et al conducted a telephone survey in the Chicago area, interviewing the chief embalmer or funeral director at 100 funeral homes. A total of 30 people surveyed declined to participate, but the 71 respondents estimated that they remove approximately seven devices per year (with responses ranging from one to 50 devices per year).

"When people die with implantable devices, there is no formal process by which morticians are notified; they just find them when they embalm the bodies," Kirkpatrick commented. "Most of them appear to be left in, since morticians do not routinely remove them." 

In fact, almost half of the morticians surveyed said they put explanted devices in the medical waste; however, four out of every five said that they believed routine postmortem device interrogation, as well as routine device removal and return to manufacturers, was feasible. Less than one third felt it would be appropriate to interrogate the device without the families' consent, and only one in 10 said that it would be appropriate to remove the device for analysis without consent from next of kin. On the flip side, embalmers and funeral directors surveyed estimated that roughly two thirds of families would agree to device interrogation or removal for analysis.

Morticians volunteered a lot of "extra" information outside the survey questions, Kirkpatrick noted.

"We were rather surprised to learn that devices are routinely implanted into pets, especially dogs," he said; two of the people surveyed reported that they'd donated devices for animal use.

As well, 13 morticians surveyed mentioned donating devices to charities that check them for battery life, "then give them to medical missionary physicians who transport them overseas to be implanted into needy patients," Kirkpatrick explained. In all, charities handle more than 2000 devices per year, which they interrogate, make the records available to manufacturers, then sterilize and send overseas. Some charities even provide a tax-deduction receipt for the value of the device. Many of the morticians interviewed, however, had never heard of these charities.

It is not illegal to donate these devices for overseas use, as long as medical missionaries personally take the devices abroad, Kirkpatrick explained. "It is against the law to reuse devices in the US, and I should emphasize that the major device companies do not reuse devices and they do not officially approve of the reuse of devices," Kirkpatrick clarified. "They have a very strict, detailed, and careful procedure for what they do with any devices that are returned to them, including extensive cataloging, analysis, and storage."

To heartwire, Kirkpatrick said that his primary concern is not so much with device destination, but proper analysis of the devices postmortem to enhance knowledge about potential device failures.

"I cannot speak for my fellow authors on this point," he commented, "but as someone interested in medical missions, and having been on a few short-term mission trips, I rather like the idea of reusing devices in the appropriate settings, with appropriate safeguards."

Kirkpatrick and colleagues conclude that morticians, in general, appear to believe device retrieval/interrogation is feasible, as long as next of kin provides consent. People with devices may want to consider "device advance directives" to direct postmortem handling of their devices, they add.