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Dr. Campbell: New technologies must be tested, effective

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RALEIGH, N.C. -

Now, more than ever, hospitals are competing.  Competing for doctors, competing for patients, competing for technology and services.  

On television and radio, there are commercials that tout the experience or super-advanced technological offerings of one hospital system over other competing institutions in a given area.  Marketing and "show and tell" ads are aimed at the medical consumer in order to bring them through the doors to seek care.  

Sometimes hospital systems purchase technologies that are likely not cost effective (or even equal in efficacy to older technologies)  in order to "keep up with the Jones" across town.

Some of these expensive devices quickly end up under a layer of dust in the corner of a storeroom (after the TV commercials have been filmed of course).  More concerning, however, is that at the time some of the devices are purchased, no active staff member has been trained to use them.

As most good businessmen and women are trained to do, hospital administrators quickly begin to push for the equipment to be utilized in order to produce an acceptable return on investment (ROI).  Physicians are sent to "training courses" in order to gain experience by observing a number of cases in a center that has become adept at their use.  Although there are some limited "hands on" experiences, nothing substitutes for intensive training and proctoring in the operating room under the tutelage of an experienced surgeon (not a weekend course in Mexico).

A great example is the advent of the DaVinci surgical robot technology. In the last several years a big selling point for hospitals in my area was the ability to showcase a "robot surgery." With the introduction of the Da Vinci surgical system, every institution in my area began scrambling to be the first to offer the "robot." 

Physicians began to familiarize themselves with the technology and devise ways in which to utilize the device in their surgical practice.  In my institution, cardiologists and cardiac surgeons began to collaborate in order to find ways to utilize the device in the implantation of Bi-ventricular Implantable Cardioverter Defibrillators (specialized pacemakers that protect from sudden cardiac death and improve heart failure symptoms).  

We found that the minimally invasive attempt to attach the special device to the left ventricle often resulted in a prolonged, ultimately open (standard) procedure in order to get the job done.  We abandoned the technique due to the fact that the previous techniques were clearly superior.  Other specialties such as urology were able to find applications such as prostate surgery that seemed to work well in the appropriate patients.  But, this is not always the case – reports have surfaced across the country involving the use of the robotic approach in less than ideal candidates.

Don't get me wrong, innovation is never a bad thing – however, pushing patients to have procedures with a particular piece of equipment in order to gain experience or satisfy hospital administrators certainly is.  As reported last year in the New York Times, many patients have suffered harm and had serious complications related to inexperienced operators. Even more disturbing is that sales representatives for companies such as DaVinci have been implicated in manipulating surgeons and surgical schedules in order to gain cases and increase company revenue.  (see my blog about salesmen in the OR here)

In the New York Times this week, an article investigating the  concerns of robotic surgeries was published.  It appears that the company responsible for the DaVinci device may have been underreporting adverse events related to its use.  In medicine, the collection of data is essential to advancing the science.  When new techniques are utilized, it is critical that we are able to examine both the positive and the negative outcomes in order to learn how best to apply new techniques in order to improve the health of our patients.  There have been numerous studies of the DaVinci system and its effectiveness (and complications) conducted over the last 10 years and many have demonstrated serious flaws and generated real concerns.  In fact, as mentioned in the Times article, an anonymous survey of surgeons in 2010 reported a 56 percent rate of "irrecoverable operative function".

In what industry or business is a 56 percent failure rate acceptable? Certainly not in medicine, where human lives are concerned.  What exactly is the FDA doing about this?  It seems that they have issued a "stern letter of warning" to physicians and hospitals concerning underreporting of complications related to robot surgeries – sounds like "double secret probation" from National Lampoon's "Animal House" to me.

We must rethink how we evaluate new technologies and how and when we adopt them.  Innovation is key – we must continue to test and evaluate new ways to treat disease in order to advance care for our patients.  But how we go about this process is the critical piece of the puzzle.  

Rather than looking for the latest and coolest new "toy," we must carefully examine risk and benefit of these new technologies before we completely abandon the tried and true therapies of old.  FDA regulation is likely not the best answer – good judgment and real concern for patient safety by physicians and healthcare systems is more likely to produce better decisions about best practices and standard of care in the future.

 

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