Device Reps and Patient Care — An Inconvenient Truth

Device Programmer
Device Programmer

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.

By mannd

I am a retired cardiac electrophysiologist who has worked both in private practice in Louisville, Kentucky and as a Professor of Medicine at the University of Colorado in Denver. I am interested not only in medicine, but also in computer programming, music, science fiction, fantasy, 30s pulp literature, and a whole lot more.

12 replies on “Device Reps and Patient Care — An Inconvenient Truth”

I always enjoy your posts, and this one stirs up some emotion, but not much. I always found pacemakers and the programming issues intimidating and being busy, nearly always I was happy to offload that to the reps or the EP docs who were glad to have the fence of acronyms and circuit vocabulary around these patients. However, your experience and comments that the reps often know more than the implanting and following MDs, is easy to believe and pretty disconcerting.

I believe that the marketing of the wearable defibrillators by the Zoll Pharmaceuticals “reps” as agents of industry pressure, is a much deeper insult to the nobility of our decision habits and wish you would do a post on that subject sometime.

Hope you are enjoying France

Well it’s been almost two months since this was posted and I’m just reading it now. I don’t spend a lot of time “online”. All of the problems mentioned regarding reps and the benefits and pitfalls of their interaction with physicians can be applied to physicians as well. Most reps are good, knowledgeable, ethical people. A few are not. The same can be said of the few implanting physicians who will implant a device for borderline reasons because they either want the money or, more likely, they don’t want to anger a referring physician and risk losing all future referrals.
Replacing reps with hospital or physician paid employees would be exceedingly costly if we want to replicate the level of service the reps currently provide. Just the continuing training required to keep these employees up to date with the various proprietary programs in the various devices would be a challenge not to mention providing 24/7/365 coverage in hospital, clinic and office environments. What we need is better reporting and enforcement mechanisms to deal with reps and physicians who violate patient trust. By the way that is true for cath doctors and interventionalists as well as all other specialties. We do not have an effective method of self-policing and that is a bigger problem in my view.

yes sir,our job is not a time to time is Herculean task.and i want work with you sir,any information please share with us.thank you

This is an incredible post and I could not agree more. The Electrophysiology sub-sub specialty was created for this purpose, to have an expert in the complexity of arrhythmia management and pacing and to understand the complexity of device management. EP’s have relegated that duty back the industry reps with degrees in business and marketing and no medical training simply because they can and the reps will do anything to keep their business, even break the law. I loved your post and want to confirm what you have stated. What is asked of me on a daily basis should be considered malpractice and my refusal to “practice medicine” has resulted in complete loss of business but I will not forgo my personal ethics.

I would like call your attention to 4 specific papers that seem very clear on the matter of device management and the role of industry representatives. First, the HRS, ASA Expert consensus statement on the peri-operative management of patients with implantable cardiac devices. Second, the HRS recommendations on the role of Industry Employed Allied Professionals. Third, AMA Journal of Ethics, February 2010, Volume 12, Number 2: 106-110, Health Law, Liability of Industry Representatives in the OR. Lastly, HRS/EHRA Expert consensus on the monitoring of cardiovascular implantable electronic devices; Description of techniques, indications, personnel, frequency and ethical considerations.

Anyone who takes the time to read these articles would come to one simple conclusion. The responsibility for the management of any implantable cardiac device falls to the implanting, following, or expert PHYSICIAN in device management. Not to the industry rep. In fact, here is a quote from the HRS/ASA condenses statement; “However, it is not appropriate for the preoperative evaluation and prescription to be determined and delivered by an industry-employed allied professional (IAEP). We strongly support the prior Heart Rhythm Society (HRS) recommendations that representative members of the CIED manufactures cannot be placed in a position of medical responsibility to provide independent prescriptive recommendations or independent postoperative CIED care. That is well beyond their scope of practice.”

I would challenge you to read these papers, I know that lawyers do. I also would remind physician to review the “Learned Intermediary Doctrine”. This will most certainly make my point.

Thank you for bringing this travesty to light. I am researching this in depth as my ventricle was paced unnecessarily by a device rep and caused chambers to beat out of sync. My heart was better off before PM was implanted and then programmed by a rep.

What are your thought on device reps performing routine interrogations of their competitors devices. I see this happen on a daily basis. The reps go so far as “borrowing” other company programmers from hospitals and cardiology offices to carry across town for this purpose. So unethical, and for the purpose of bagging a sale when a pacemaker battery is due for replacement.

I always wonder how how the doc and rep would fare if this was reported to the medical board and local news… would be huge on the news I inagine

There are good decent upstanding hard working device reps and there are sleaze bags. Just as there are great doctors and sleazebag doctors. The same can be said for attorneys, dishwashers, etc. I think it is unfair to characterize an entire profession as being unethical. It is not the case. I have heard of reps doing terribly unethical things like turning up outputs on devices to deplete batteries to generate sales. I have also experienced having a great rep prevent me from replacing a device that was sent to me as at battery depletion that wasn’t actually depleted thus preventing an unnecessary procedure and a commission for this honest rep. IMHO what’s lacking in medicine is a credible way of reporting reps, doctors, nurses and other health care providers who are suspected of unethical behavior. We simply do not have a good mechanism to do that. Hospital “quality committees” will often handle the worst offenders but it’s not good enough. I would like to see each state have a Quality Assurance Board that will investigate complaints by reviewing records and conducting informal interviews just to see if there is merit to reporting a provider to the appropriate credentialing board for further review. I can tell you there is a physician in my town affiliated with a health care system other than the one I work for who is doing unnecessary procedures and many people know it. Where do I go with that information with any chance that someone will do something about it? Unethical pacer reps are bad news but there’s plenty of bad news to go around.

I have been a device rep for 22 years and have very much enjoyed it. As is true in all levels of health care, there are good and bad. We all are in a position to hold each other accountable and should. That said, in my 22 years, I don’t recall any licensed provider taking kindly to any criticism from an industry rep, no matter how constructive. Egos typically run high on both sides. This is likely the biggest barrier to improving care in my opinion.

Thanks for your perspective Jon. I have dealt with many superb device reps. Reps are sometimes put into bad situations by physicians which is a shame because they are generally highly trained but not in a good position to push back against physician requests. And there is no doubt that egos can get in the way, especially on the physician side in my experience!

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