Why Pacemaker Recalls May Soon be Called Something Else

It seems that every medical specialty has its own special meeting and that's true for the doctors and nurses who specialize in pacemaker therapy. Their specialty society is called the Heart Rhythm Society or HRS and it just convened in Boston.

With many topics on the agenda, one that appears particularly newsworthy is one in which official recommendations about device performance.

In specific, doctors asked that the word recall not be used for problems with pacemaker or defibrillator safety and instead that a more benign term like safety advisory be used.

One thing medical people talk about frequently is how well pacemakers, defibrillators, and related products perform. Although the FDA has found pacemakers, defibrillators, and their wires (or leads) as safe and effective, they are man-made devices.

As such, from time to time, manufacturers and regulatory bodies like the FDA periodically notify doctors about problems with specific products. When this happens, the physician is charged with informing patients and then sitting down with them to figure out the most appropriate steps to take. The problem with pacemaker recalls, oh, excuse me, I mean safety advisories, is that they are often very complicated.

When an advisory occurs, it often affects only a group of pacemakers (for example, let's say 10,000 pacemakers out of 200,000 implanted) but the actual problem may only occur in a small percentage (say 1 or 2 percent) of that subset. So sometimes an advisory means trying to sort out whose device is actually going to have a problem. Furthermore, some problems are not serious enough to warrant surgically removing the pacemaker and replacing it with a new device.

Every surgery involves certain risks and sometimes the risks of a second surgery exceed the risks associated with having a device under advisory. The point is, doctors are supposed to meet and confer with patients about the situation to arrive at the right course of action. People who are very frail will likely be advised to avoid another surgery; people who depend on their pacemaker but are otherwise fit, may be better off having the device replaced.

The trouble with the word recall is that it strikes an alarmist note that may cause doctors and patients to want to go to the radical step of having a device removed and replaced instead of monitoring it or taking less aggressive steps until the true scope of the problem can be sorted out.

Another item in the HRS recommendations on pacemaker performance is that doctors and nurses should try to give patients realistic expectations about pacemaker therapy. This includes letting them know that devices can encounter problems even after they are implanted in the body.

Another important issue is longevity, but it refers to the pacemaker and not the person who has it. Pacemakers and defibrillators are battery-powered devices which will eventually run out of battery power and require replacement.

Pacemaker manufacturers are asked to do better post-marketing surveillance or PMS as it is called in the industry. PMS means that once a pacemaker is brought to the market, companies should follow reports on potential problems or issues very closely.

Overall, HRS found that there were unrealistic ideas among healthcare professionals and the people they care for in terms of pacemakers. Since the vast majority of pacemakers, defibrillators, and leads give years of trouble-free performance, it is easy for doctors and patients to get in the habit of assuming that problems can never happen.

If you have a pacemaker that may be part of an advisory or you are just concerned about advisories in general, your best first source of information is your doctor or nurse.

You may also be able to get guidance from other people who have been there by contacting a pacemaker or defibrillator forum. (Just search for pacemaker forum or defibrillator forum and see what sites come up. Forums are usually easy to join and free.)

If you have a device that is under advisory (as it is now called), discuss your options with your doctor. A lot depends on your individual case, that is, your overall health and fitness, how old the pacemaker is, what kind of problem is involved, and the likelihood that your device is one of the problem ones. For that reason, two people with exactly the same diagnosis and exactly the same pacemaker may reach two entirely different plans for how to manage a safety advisory.

People with pacemakers should expect that their doctors and nurses are going to start trying to make them more aware that implantable devices like pacemakers are not foolproof and that electronic or mechanical problems can occur and have occurred. There is a danger that this will scare some people and another danger that it will bore others after a while. But it is probably a smart idea to help people get a realistic concept about how pacemakers and defibrillators work. That concept has to include the fact that they sometimes experience problems.