Device Reps and Patient Care — An Inconvenient Truth

Most people who don’t deal with the Health Care System on the inside are likely unaware of the exact role that industry representatives play in the care of patients. As a cardiologist who implants pacemakers and defibrillators, I have worked with the representatives of the companies that manufacture these devices for many years. I will use the term “device reps” for these people, mostly because that is usually how they are referred to on a day-to-day basis, but in using this term I am referring both to device sales representatives and to device field clinical specialists. In theory the sales reps are more involved with sales, and the field clinical specialists with technical support, but in practice there is a blurring of these roles, with considerable overlap even in the job descriptions and training required, as can be seen here. Generally both jobs require at least a bachelor’s degree and training by the device complany. Although there is no specific requirement for a health care degree, some of these people are former nurses, cath lab technicians, or physicans assistants. On the other hand some, in particular the sales reps, have a background in business and not health care. Despite this, the job description of the sales rep includes providing pacemaker and defibrillator follow-up, technical assistance, programming, troubleshooting, and training.

So what does this translate into in practice? For one thing, these device reps are present in the cath lab or operating room when pacemakers and defibrillators are implanted. They are there to provide the actual devices and run the programmer (essentially a specialized computer for testing and programming devices). In my experience they never scrub in or otherwise assist in the procedure. Using these same programmer machines (note that each company has its own programmer and they are not compatible with other company’s programmers) the reps test and reprogram devices throughout the hospital, at least technically under supervision of a physician, though the physician may not be physically present. They often do the same thing in doctor’s offices, especially for physicians who do not have dedicated staff to follow pacemakers or defibrillators. They provide these services at no cost to the hospital or physician, though presumably the cost is bundled into the rather hefty price tag of pacemakers and defibrillators.

These services are not performed rarely. The reps take call at night and are expected to be available 24 hours 7 days a week. Each device company provides its own group of reps.  Because the implantable device business is very competitive, any company providing less than this level of service would soon lose its business. Hospitals and physicians receive a “free” service that, if it did not exist, would have to be provided by hiring their own technical personnel at considerable cost. The industry argues that only they know their proprietary products well enough to provide adequate technical support, and there is certainly some truth to this argument.  In general, I think most hospitals and physicians see the present system as perhaps a little awkward but beneficial and don’t want to kill the goose that laid the golden eggs.

Nevertheless, the current system is rife for abuse. Let me first say that most of the industry reps I know and have worked with are exceedingly technically knowledgable and good, ethical people whom I would rather have program my pacemaker than some of the doctors whom they work for. But I also should say that there are exceptions, and a small minority are really just interested in sales and are not so technically knowledgable. So this brings us to the most obvious problem with this system:

Why is a sales person assisting in implanting my pacemaker or changing settings on my implantable defibrillator?

This is the first question that would occur to most people. The person adjusting the IV is a trained nurse. The person adjusting the ventilator settings is a trained respiratory technician. Neither one is trying to sell IV equipment or ventilators. Why does a sales person program a pacemaker?

I remember back when I was in training in the early 1980s the TV program 60 Minutes  came to Baylor in Houston purportedly to do a documentary on new pacemaker technology. Our pacemaker specialist, Dr. Jerry Griffin, was interviewed in his office about this subject. The CBS crew then requested to film a pacemaker implantation procedure in the cath lab. Consents were signed and the procedure was filmed. No one realized that the whole thing was a bait and switch. Everything else was edited out and the only thing shown on TV was the bit where Jerry asked for the pacemaker from the sales rep in the room. The show was actually an expose on relations between the pacemaker industry and physicians and the fact that industry sales people were in the cath lab assisting in pacemaker implantation. About the same time, there was a US Senate investigation of the pacemaker industry, and amongst the many criticisms and abuses identified, the role of the sales reps in pacemaker procedures was noted. All this has led to a crackdown on industry reps providing physicians trinkets such as pens, but the role of the reps in device implantation and follow-up seems not to have changed a whit.

The present system is flawed and suffers from a lack of oversight. Despite an attempt by the Heart Rhythm Society to codify the relationship between industry and physicians, there really aren’t any hard and fast rules. This leads to abuse of the reps themselves, and some questionable practices. The reps have been trained never to say “no” to any request by a physician. Courts have ruled that it is not the responsibility of the rep to correct the physician if the physician is doing something wrong. So what is a rep to do if an undertrained physician asks him or her to program a device in a fashion detrimental to a patient? The rep is in a bad spot, risking losing business from that physician if he or she doesn’t just “follow orders.” Although it is well established that other healthcare personnel should speak up and question orders they seem to be in error, there is no expectation that a sales rep should do so. In large part this is a fault of the device industry that has often tried to train physicians in pacemaker implantation who have not undergone formal pacemaker implantation training, in order to increase sales.  This can result in the awkward situation of the rep being more knowledgable than the supervising physician.

Device reps are also often asked to program devices on and off for surgery, when it really is not necessary to do this. Much of the time no programming needs to be done in this situation, or only a pacemaker magnet needs to be applied during the course of the surgery to put the device into a “safe” mode that won’t cause problems when the surgeon uses electrocautery. These unncessary programming interactions are abusive to the device reps, could conceivably result in incorrect programming, are costly to the patient (device programming is billed by the supervising physician), and lead to delays in starting surgery while waiting for the device rep, notified invariably at the last minute, to drive from one hospital to another. Since the whole device rep system is outside the normal hospital chain of command, it is difficult for the devices reps to find a champion who would talk to the anesthesiologists or surgeons and change this policy. I mention this example because I saw it again and again in one hospital in particular in Louisville, Kentucy, where I worked.

Device reps can get in over their heads. In the emergency room in the middle of the night they may be asked to use the device to electrically cardiovert or pace terminate an episode of ventricular tachycardia. They may be the only one in the room who knows what they are doing. The cardiologist is happy he or she doesn’t have to get out of bed to do this. Yet here again this is a person often without a medical degree performing a medical procedure with potentially serious consequences. The device rep may also be asked to turn off a defibrillator or pacemaker in a terminally ill patient. While turning off a defibrillator generally has no immediate effect, turning off a pacemaker in a patient who is dependent on the pacemaker results in death that occurs about as fast as a gunshot to the head. To push that button on the programmer that shuts off the pacemaker is as morally vexing an act as one can conceive of, yet this is something that we ask the device rep to do (“under physician supervision”).

Device follow-up in the office doesn’t have to be done by device reps, yet it often is. In the Heart Rhythm Center at my former work-place all the device follow-up was done by trained nurses and technicians. Many cardiologists though have a rep come to their office periodically to do device follow-up. There is push-back against changing this system, because device follow-up generates income. Yet often the “supervising physician” has no training in pacemaker follow-up and leaves the programming decisions to the rep. This is wrong.

So, what to do about all this? The system is quite well-entrenched and I’m not sure if it can be changed. I think having the rep in the cath lab during device implants, that was so shocking to the 60 Minutes viewers, is probably the most justifiable of these practices. They are equipped with all sorts of leads, adaptors, and devices that really are necessary to have to do the procedure. Their role of assessing pacing thesholds and device function is not particularly troublesome, especially as this is the one situation where the supervising physician is actually guaranteed to be present.

Regarding device follow-up and reprogramming in the hospital and doctor’s offices, I do think it would be better if it were done by specialized personnel who work for the hospital or doctor, and not for the various device companies. This is already done is some doctor’s offices, such as our own. This would require an outlay of cost by the hospitals, as someone would have to be on call all the time for these services. I suspect that most hospitals would prefer to keep the current system, but in the long run having a minimal sales presence in the hospital might lead to lower costs of devices.

I’m curious what other physicians or health care workers think about this. What do the reps think about it? What do people on the receiving end, i.e. patients with implantable devices think about it? It doesn’t seem to be discussed very much. Please feel free to leave any comments you might have.