| Neurosurgeons must be able to rely on the varacity and integrity of the information provided by product representatives in the treatment of their patients |
The application of technology to neurosurgical patient care, the complexity of the devices and the furious pace of change have facilitated the growth and acceptance of a collaborative care paradigm in which neurosurgeons work closely with product representatives to bring new technology-based solutions to their patients.
It is now quite common for product representatives to be present and to function in sophisticated support roles during surgical procedures, a situation that contributes to the ability of neurosurgeons to care for their patients. These representatives are well trained in the various attributes and uses of their products and often are highly educated as well. However, unlike physicians and other members of an operative team, they are not certified by any public entity and have no recognized fiduciary duty to the patient. Thus, even a well-intentioned manufacturer’s representative — who essentially is a sales representative — will have an inherent conflict of interest between fulfilling employer expectations and attending to the well-being of the patient.
In the interest of patient safety, it is time to adapt the collaborative care paradigm so that the integral role played by product representatives in bringing new and beneficial technologies to our patients is acknowledged and that attendant responsibilities also are appropriately assigned.
The Traditional OR Team — Redefined
Collaborative care is a complex phenomenon, and in one sense it has always been a part of the neurosurgical operating theater. For example, consider the surgeon, anesthesiologist, nurse anesthetist, circulating nurse, scrub technician, and X-ray technologist working together as a collaborative care team throughout a surgical case. In this traditional paradigm, well-defined roles and boundaries have developed over time. These team members either are professionals with a code of ethics and recognized duties and accountability under the law or they operate under the supervision of the professionals. The primary duty of every member of the care team is to the well-being of the patient, and no systemic conflicts of interest interfere with that duty.
The introduction of product representatives to the operating theater has added a new dimension to the collaborative care team. If the role of product representatives were simply that of maintenance of instrument inventory, there would be no need for them to be present during surgical procedures or to offer guidance to the surgical staff or the operating neurosurgeon. Rather, their role is to support their employers’ technology and to facilitate its use when deemed appropriate by a physician. This role becomes increasingly critical as the technology increases in sophistication.
For example, the software technology for image-guided brain biopsies is constantly updated with new features and capabilities. In addition, to improve the efficiency and accuracy of surgical steps such as registration, the user interface has become increasingly sophisticated. The surgeon who frequently uses the technology will become knowledgeable and comfortable with these features and will require little support from the product representative. A surgeon who uses the technology infrequently but considers it critical to offering the best possible patient care will need to rely more on the product representative for guidance in the proper use of the equipment and to troubleshoot any difficulties that arise throughout the case.
When during a surgical procedure unexpected issues require revision of the original surgical plan, a product representative present in the OR often suggests solutions, based on product features, that have been used effectively under similar circumstances. The representative’s failure to accurately convey information or to fully disclose facts needed by the neurosurgeon in order to appropriately utilize technology could result in harm to the patient.
Apportioning Responsibility: Current Thought
A recent malpractice case, reported in the Summer 2005 issue of the AANS Bulletin and summarized here, illustrates this circumstance and how a jury might view the situation. During an operative case a neurosurgeon decided not to use a cranial plating system or its titanium mesh cranioplasty alternative because of concern with scalp erosion, and he instead used a self-hardening hydroxyapatite cranioplasty material recommended by a product representative on the premises. The representative guided OR staff in preparing the product and the neurosurgeon in applying it. The cranioplasty material subsequently decomposed, and the patient required several additional surgeries.
At trial the neurosurgeon’s attorney argued that the product representative in an operating room has a duty to the patient, including the duty to communicate all of the product’s attributes, especially when use of the product is proposed to remedy a surgical problem that occurs during an operative case. The manufacturer’s defense argued that it is the neurosurgeon’s responsibility to educate himself or herself and that there is no duty for a product representative to warn a physician if the product is being used in an improper fashion, even when harm to a patient might reasonably result. The jury found in the plaintiff’s favor, apportioning responsibility for the award 75 percent to the neurosurgeon and 25 percent to the product manufacturer.
Extrapolating this case for discussion purposes to other types of products and devices being developed and introduced for advancing patient care, it is unrealistic to presume that neurosurgeons can verify through their own due diligence and study of technological solutions all of the information presented by product representatives. At some point the fund of information available to a product representative who is both dedicated to and extensively trained on a small product line surpasses the treating neurosurgeon’s fund of knowledge on that technology. Neurosurgeons must be able to rely on the veracity and integrity of the information provided by product representatives in the treatment of their patients, and the fiduciary duty to place the patient’s interests above all other considerations should in part transfer to those providing advanced technological support.
If all or the majority of accountability continues to fall to neurosurgeons, then they will have to limit their use of technological solutions to those with which they are completely familiar, highly trained, and able to troubleshoot individually. This will result in a slowing of the introduction of new technology into patient care and its attendant benefits. Furthermore, it will limit the ability of neurosurgeons to rely on product representatives for education regarding products and technical solutions and will require them to take time away from patient care for independent study of these solutions if they wish to use them. It also could lead to an increase in device-driven subspecialization, which could have the unfortunate effect of decreasing patient access to neurosurgical care.
A New Model
A new model makes sense for the provision of excellent state-of-the-art patient care in an increasingly complex collaborative care environment.
When a product representative is invited to offer technological support in the operating theater during an episode of care, then there should be a duty to provide accurate information inclusive of all facts that may influence the surgeon’s decision making. This duty and the associated accountability for providing accurate and complete information regarding a particular technology should reside with the product representative.
The neurosurgeon, on the other hand, is making decisions regarding care based upon the progress of the operative intervention and the information supplied to him or her by the product representative. The duty to make reasonable, prudent decisions within the standard of care and execute them appropriately should reside with the neurosurgeon, and the accountability for that aspect of care should remain with the neurosurgeon.
Although one may envision mastering spinal instrumentation sets to the point that there would really be no need for input from a product representative, the likelihood of the neurosurgical community as a whole mastering software updates and troubleshooting electronic interfaces such as those used with intraoperative image guidance is difficult to envision. It is reasonable to assert that in the interest of patient care and patient safety, the appropriate responsibility for technology support is assigned to the product representative; but as that occurs, so too is accountability assigned.
Adoption of this new paradigm would be an adjustment for all parties concerned, but it would acknowledge that to ensure optimal patient care and safety, multiple specialized roles are necessary in the application of technological solutions to neurosurgery.
Patrick W. McCormick, MD, FACS, MBA, is a partner in Neurosurgical Network Inc., Toledo, Ohio.
Related Article
- McCormick, PW: OR friend/courtroom foe: does a product rep in your OR have a duty to your patient? AANS Bulletin 14(2):15, 2005. www.AANS.org, Article ID 37047