MEDICAL DEVICE FIELD PERSONNEL IN CLINICAL SETTINGS

Overview

1. Medical Device Field Personnel Play an Important Role in Clinical Settings
   
   The presence of medical device field personnel in clinical settings, including the operating room, is not just common but often necessary. The role of medical device field personnel includes providing in-depth device-specific technical information directly to physicians and other HCPs to support safe and effective use of the device. This kind of support is particularly important in situations where use of the device is technologically complex. A number of prominent medical organizations and institutions, including the American Medical Association (AMA) and the Mayo Clinic, have recognized that these individuals play “an important role in patient safety and quality of care” in providing technical support to physicians and their staffs:
   
   
   1. The American Medical Association (AMA): “Representatives of medical device manufacturers can play an important role in patient safety and quality of care by providing information about the proper use of their companies’ devices or equipment and by offering technical assistance to physicians.”²
   2. The American College of Surgeons (ACS): Health care industry representatives, such as medical device field personnel, “by virtue of their training, knowledge, and expertise, can provide technical assistance to the surgical team, which expedites the procedure and facilitates the safe and effective application of surgical products and technologies.”³
   3. The Association of Perioperative Registered Nurses (AORN): “By virtue of their training, knowledge, and expertise, health care industry representatives can provide technical support to the surgical team to expedite the procedure and facilitate desired patient outcomes.”⁴
   4. The Heart Rhythm Society (HRS): “[Industry employed allied professionals] often have expertise about specific features of pacemakers or ICDs that is unique to the manufacturer’s product. This expertise may be extremely valuable to physicians and the clinical allied professionals … they employ.”⁵
   5. The Mayo Clinic: “[Medical device field] representatives, by virtue of education, training, and expertise, often serve as a resource for physicians, researchers, and allied-health staff through the sharing of product information, technical information and the provision of education and training.”⁶
   
   

2. Medical Device Field Personnel Provide Technical Support
   
   Medical device field personnel are present in clinical settings in order to provide technical support, not to participate in the practice of medicine. The technical support provided can take many forms. One form of technical support is providing technical information to the treating physician about programming implantable devices. For example, a spinal cord stimulator—a device that reduces pain by sending electronic signals to a patient’s spine through a wire or “lead”—can be programmed to send current with differing amplitude, frequency, and pulse width. After the device is implanted, it is often necessary to try various stimulator settings to optimize the patient’s pain relief. Medical device field personnel, who are extensively trained on the parameter of ranges available for each device they support, provide technical support to the treating physician as the physician works to identify optimal parameters for that patient.

   Other forms of “technical support” include field personnel working with scrub nurses to familiarize them with a medical device and answering questions about how to prep a device for surgery. Also, many devices are comprised of, or are capable of being used with, multiple other devices and/or accessories, and the possible combinations may vary widely. Field personnel are able to help the surgical team ensure that the potential range of necessary devices and accessories are available at the surgery. In addition, medical devices often have short product cycles, and new models are released relatively frequently. Doctors and other healthcare providers cannot reasonably be expected to have in-depth knowledge of the functionality of every new model of every new product. Medical device field personnel do have that knowledge, and they are present to answer any questions.

   Underscoring these points, in 2010, a surgeon wrote the Washington Post in response to an article about field personnel in the operating room, explaining “many products in the operating room are complex and change almost every year; they are getting better that fast,” adding that “having the rep in the room ensures that the system is functional,” and gives the surgeon and O.R. staff confidence that “all the parts will be there.”⁷

3. Field Personnel Must Complete Device-Specific Training and Meet Other Requirements Before Assisting in an Operating Room

   Before providing technical support in an operating room, Medtronic field personnel must complete the following requirements:

   1. In-depth device-specific training, which usually includes classroom learning as well as observation in a clinical setting.
   2. Protocol training, including information regarding the operating room (OR) environment, sterile techniques, aseptic principles, infection control, and OR exposure protection.
   3. Health precautions training including blood borne pathogens, tuberculosis, and ionizing radiation in accordance with Occupational Safety and Health Administration (OSHA) requirements.
   4. Health Insurance Portability and Accountability Act (HIPAA) privacy and security rules.
   5. The Representative must confirm with the healthcare institution hosting the OR procedure that his/her attendance in the OR setting is in compliance with that institution’s internal policy, procedure or guidelines.
   6. The Representative, and any other Medtronic employee or contractor, must verify that his/her credentials comply with local institutional credentialing requirements for attendance in the OR.
   
   

   In addition, Medtronic Representatives in the United States receive approximately a week’s worth of training every year on quality and compliance matters.