Elevating Surgical Success:

How AORN, AMA, ACS, and Joint Commission Position Statements Overlook the Full Role of Medical Device Representatives in Surgical Case Setup

In the fast-paced and highly technical environment of modern surgery, every team member's role is crucial to ensuring a successful outcome for the patient. Among these team members are Health Care Industry Representatives (HCIRs), particularly medical device representatives, who play an indispensable part in surgical procedures. However, despite the significant contributions these professionals make, recent position statements from the Association of periOperative Registered Nurses (AORN), the American Medical Association (AMA), the American College of Surgeons (ACS), and The Joint Commission do not fully capture the extent of their responsibilities, particularly in the critical pre-operative phase.

Understanding the Guidance: What Do AORN, AMA, ACS, and The Joint Commission Say?

1. AORN Position on HCIRs: AORN’s guidelines focus primarily on the presence of HCIRs during surgical procedures, emphasizing their responsibilities to adhere to patient safety protocols and maintain ethical standards. These guidelines are vital for maintaining a safe and controlled environment in the operating room. However, AORN’s guidance tends to emphasize the intraoperative role of HCIRs, often overlooking their critical involvement before surgery begins.
2. AMA Position on Industry Representatives in Clinical Settings: The AMA acknowledges the importance of industry representatives in providing essential technical expertise and support. However, it also raises concerns about potential risks to patient autonomy, privacy, and the integrity of clinical care, emphasizing that these representatives should not substitute for proper physician training. This position highlights the importance of ensuring that physicians remain fully responsible for the care they provide, yet it does not fully address the educational and technical support that representatives offer before surgery.
3. ACS Revised Statement on HCIRs in the Operating Room: The ACS outlines a structured framework for the involvement of HCIRs in surgical settings, noting their role in providing technical assistance and education to the surgical team. However, the ACS also clarifies that the presence of an HCIR cannot replace the necessary preoperative training for the surgical team. While this guidance is crucial, it does not adequately address the preparatory work that medical device representatives perform to ensure that the surgical team is ready for the procedure.
4. The Joint Commission’s Standards for Non-Licensed, Non-Employee Individuals: The Joint Commission’s standards emphasize the need for healthcare organizations to monitor and manage the presence of non-licensed, non-employee individuals, such as HCIRs, to ensure patient safety and privacy. The standards require that organizations verify the qualifications, competency, and performance of these representatives, especially when they are involved in patient care activities within the operating room. However, like the other guidelines, these standards do not fully acknowledge the critical pre-operative roles these professionals play.

The Overlooked Pre-Operative Role: Setting the Stage for Surgical Success

While the guidance from these leading organizations is invaluable, it often overlooks the essential role that medical device representatives play before the first incision is made. These professionals are not merely observers or troubleshooters; they are integral to the preparation and setup that ensure a smooth and successful surgical procedure. Here’s a closer look at their often-underappreciated contributions:

1. Complex Equipment and Instrumentation Setup: Medical device representatives are typically among the first to arrive in the operating room, tasked with the intricate setup of advanced surgical equipment. Their deep technical knowledge enables them to assemble, calibrate, and test devices to ensure they are functioning perfectly. This meticulous preparation is crucial for preventing equipment malfunctions that could lead to delays or complications during surgery.
2. Ensuring Sterility and Compliance: In addition to setting up equipment, these representatives are responsible for ensuring that all instruments meet sterility standards. They work closely with the sterile processing department to confirm that devices are properly cleaned and sterilized according to both manufacturer instructions and hospital protocols. This step is vital for maintaining the sterile field and reducing the risk of surgical site infections.
3. Providing Real-Time Technical Support: While their preoperative work is critical, medical device representatives also offer invaluable real-time support during the procedure. Their presence allows the surgical team to focus entirely on the patient, confident that any technical issues can be swiftly addressed. However, this support is only as effective as the groundwork laid during the preoperative phase.

Are Patients Aware of the Full Role of Medical Device Representatives?

While patients might be aware that a medical device representative—a non-hospital, non-certified employee—may be present during their surgical procedure, are they truly aware of the extent of the representative’s involvement? Specifically, do they know that these representatives often play a crucial role in setting up for their surgery, including the ordering, logistics, preparation and calibration of the equipment and instruments that will be used? This gap in awareness underscores the need for greater transparency and patient education regarding the full scope of responsibilities that these professionals undertake to ensure a successful surgical outcome.

Bridging the Gap: Aligning with Comprehensive Guidelines

The positions of the AMA, ACS, and The Joint Commission all stress the importance of ensuring that medical device representatives do not overstep their roles and that they are properly integrated into the surgical team. This is where the alignment of their preoperative duties with these guidelines becomes crucial:

• AMA’s Focus on Ethical Boundaries: The AMA’s emphasis on ensuring that representatives do not replace physician training aligns perfectly with the representative’s role in preparing the surgical environment. By ensuring that all equipment is ready and functioning, representatives help create a safe and efficient operating room where physicians can perform at their best.
• ACS’s Emphasis on Preoperative Training: The ACS guidelines underscore that HCIRs are educators and facilitators, not substitutes for surgical training. This principle is exemplified in the representative’s role in ensuring that the surgical team is familiar with the equipment and that all devices are correctly set up, minimizing the need for on-the-fly adjustments.
• The Joint Commission’s Standards for Competency and Compliance: The Joint Commission’s focus on verifying the competency and qualifications of HCIRs directly relates to the representative’s preoperative responsibilities. Ensuring that representatives are well-trained and capable of performing their tasks effectively is essential for maintaining patient safety and surgical efficiency.

Case Study Reflection: Ethical Considerations and Best Practices

A recent case study published in the AMA Journal of Ethics provides a poignant example of the ethical dilemmas that can arise when the roles of medical device representatives are not clearly defined or respected. The study describes a scenario where a surgeon, lacking sufficient training with a new implant, relied heavily on the guidance of a device representative during surgery. This situation not only compromised the patient’s safety but also highlighted the importance of proper preoperative preparation and clear communication about the roles and limitations of representatives in the operating room.

The case underscores the need for healthcare organizations to establish robust policies that clearly define the expectations and responsibilities of medical device representatives. These policies should ensure that representatives are fully integrated into the surgical team’s workflow, with a strong emphasis on preoperative preparation and ongoing communication.

NAMDR Call to Action: Updating the Role of HCIRs in Line with NAMDR Guidelines

In light of the evolving responsibilities of medical device representatives, the National Association of Medical Device Representatives (NAMDR) urges all healthcare associations, accrediting bodies, and healthcare facilities to update their guidelines and policies to better reflect the full scope of HCIRs' roles. NAMDR has established comprehensive guidelines that not only align with the principles set forth by AORN, AMA, ACS, and The Joint Commission but also expand on them to include the critical pre-operative responsibilities that are often overlooked.

NAMDR’s Guidelines Include:

• Pre-Operative Equipment and Sterility Checks: Detailed protocols for the setup and verification of surgical equipment and instruments, ensuring that all devices are sterile and ready for use before the procedure begins.
• Enhanced Training and Certification Requirements: NAMDR advocates for rigorous training and certification for medical device representatives, ensuring they are fully qualified to perform their duties and support the surgical team effectively—from surgical tray management to surgical case setup and their role within the surgical environment. NAMDR believes that such certification elevates the professional standards for Medical Device Representatives, holding them to a higher level of accountability and expertise than what is currently required today. This enhanced standard ensures that representatives are not only knowledgeable but also fully prepared to contribute to the success and safety of every surgical procedure.
• Patient Safety and Confidentiality Protocols: Strengthened measures to protect patient privacy and ensure informed consent, aligning with the latest ethical standards and regulatory requirements.
• Clear Role Definitions: NAMDR provides clear guidelines on the roles and limitations of HCIRs, ensuring they are integrated into the surgical team as educators and facilitators, without overstepping into clinical decision-making or direct patient care.

Understanding the Difference: Vendor Credentialing vs. Certification

In the complex landscape of healthcare, particularly within surgical environments, there is often confusion between vendor credentialing and professional certification. It is crucial to understand that vendor credentialing, while important, is not the same as certification. Vendor credentialing primarily serves as a vendor access management system for healthcare facilities, categorized into Tier 1, 2, and 3 access levels as defined in ANSI/NEMA SC 1-2020 Standard. This process typically involves verifying that a vendor or representative meets certain basic requirements to enter a healthcare facility, such as completing background checks, providing proof of vaccinations, and complying with facility-specific policies. However, vendor credentialing does not assess or ensure the representative’s technical competence or their ability to contribute effectively to patient care, particularly in critical areas like surgical tray management or surgical case setup. A Key component to the safe cleaning, disassembly and assembly of surgical instruments and implants comes from Instructions For Use (IFU).

In contrast, certification, as advocated by NAMDR, is a rigorous process that goes beyond basic credentialing. Certification involves comprehensive education, training, retraining and assessment to ensure that a medical device representative is fully qualified to perform their duties within the surgical environment. This includes a deep understanding of the technical, clinical, and regulatory aspects of medical devices, as well as the critical roles they play in surgical procedures and surgical case setup.

Educational Requirements Under ANSI/NEMA SC 1-2020 Standard Include:

1. Aseptic Techniques: Ensuring that representatives are trained in maintaining sterile environments to prevent infections during surgical procedures.
2. Bloodborne Pathogens: Educating representatives on the risks and prevention methods related to exposure to bloodborne pathogens in the surgical environment.
3. Electrical Safety: Training in the safe use of electrical equipment and devices in the operating room to prevent accidents and ensure patient safety.
4. Ethics and Code of Conduct: Establishing a strong ethical foundation, including adherence to codes of conduct that prioritize patient safety and professional integrity.
5. Fire Safety: Providing education on fire prevention, safety protocols, and emergency response within the operating room environment.
6. Handwashing: Emphasizing the importance of hand hygiene to prevent the spread of infections within healthcare settings.
7. HIPAA: Ensuring representatives understand and comply with the Health Insurance Portability and Accountability Act (HIPAA) to protect patient privacy and confidentiality.
8. Operating Room Protocol: Educating representatives on the specific protocols and standards required within the operating room to maintain a safe and efficient environment.
9. Product Complaints and Medical Device Reporting: Training representatives on the procedures for reporting product complaints and adverse events related to medical devices, in compliance with regulatory requirements.
10. Product/Service Competency: Ensuring that representatives have a thorough understanding of the products and services they represent, including their correct and safe usage.
11. Radiation Safety: Training in the principles of radiation safety to protect both patients and healthcare workers from unnecessary exposure.
12. Radiation Dosimetry Monitoring: Educating representatives on the use and interpretation of dosimetry monitoring to track and manage radiation exposure.

Gaps in Current Credentialing:

Today, these educational requirements, while comprehensive, do not specifically address the critical tasks of surgical tray management and surgical case setup. These areas are vital to ensuring that surgical procedures are conducted safely and efficiently, yet they are often overlooked in standard vendor credentialing processes.

While there are multiple vendor credentialing companies currently in operation, NAMDR has focused on establishing the requirement for a HCIR certificate aligned with the ANSI/NEMA SC 1-2020 standard. This certification will set a higher benchmark for medical device representatives, ensuring that they meet rigorous educational and professional standards that go beyond basic credentialing. Our goal is to make this certification a necessary requirement across the industry, elevating the role of medical device representatives in healthcare and ensuring safer, more effective surgical practices. The HCIR certificate is to the ANSI/NEMA SC 1-2020 standard for which is currently Vendor Credentialing but it is not Certification for surgical tray management, surgical case setup and Surgical case coverage. NAMDR believes a CMDR (Certified Medical Device Representative) certification should be the standard for Medical Device Representatives who are invited to the Surgical Suite.

Healthcare Facilities, Medical Device Representatives, Medical Device Companies and Vendor Credentialing companies that carry the NAMDR Certification mark show they are committed to the highest level of service and focus on Patient care.

NAMDR’s Vision for Safer Surgical Practices:

To address these gaps, NAMDR has developed guidelines that we intend to establish as a standard for safer patient surgical case setup. Our guidelines emphasize the importance of thorough training in surgical tray management and case setup, ensuring that medical device representatives are fully equipped to support surgical teams in these critical areas. By going beyond the basics covered in current credentialing systems, NAMDR's certification process aims to elevate the role of medical device representatives, ensuring they contribute to the highest standards of patient care and surgical safety.

Commitment to Accreditation and Standards Development:

NAMDR is not just advocating for higher standards; we are actively working towards becoming the recognized authority in this space. We are the only organization today providing a certificate aligned with the ANSI/NEMA SC 1-2020 standard, and we are currently pursuing ANSI/ANAB accreditation to further validate our certification process. In addition, NAMDR is working towards becoming an ANSI Standards Developer, a move that will allow us to play a crucial role in shaping future standards for medical device representatives and healthcare industry representatives at large.

Becoming a Patient Safety Organization (PSO):

Recognizing the importance of structured, standardized processes in improving patient outcomes, NAMDR has also filed to become a Patient Safety Organization (PSO). This status will enable us to collect and analyze data on the safety and effectiveness of practices involving medical device representatives, further contributing to the development of industry-wide best practices and standards.

NAMDR's Stance:

NAMDR believes that adopting comprehensive certification standards, will lead to a more qualified and competent workforce within healthcare settings. This approach not only enhances patient safety but also improves surgical outcomes by ensuring that medical device representatives are thoroughly equipped to contribute effectively to all aspects of the surgical process, including those currently overlooked by traditional credentialing. By distinguishing between basic vendor credentialing and professional certification, NAMDR is committed to elevating the role of medical device representatives, ensuring they are fully prepared to meet the demands of modern surgical practices. Our ongoing efforts towards ANSI/ANAB accreditation, becoming an ANSI Standards Developer, and obtaining PSO status further underscore our dedication to advancing patient safety and surgical success.

A Call to Action: Recognizing and Supporting the Full Scope of Medical Device Representatives

As we strive to improve patient outcomes and surgical success, it is essential that we fully recognize and support the critical role of medical device representatives. Their contributions in the preoperative phase are not just supportive—they are foundational to the overall success of the surgical procedure. By expanding our understanding and appreciation of their role, we can better integrate these professionals into the surgical team, ensuring that all members are working together to achieve the highest standards of patient care and safety.

We urge all healthcare professionals—perioperative nurses, surgeons, administrators, and medical device representatives themselves—to engage in discussions about how we can better acknowledge and incorporate the full scope of these representatives’ responsibilities into our practices. By aligning with NAMDR’s updated guidelines, we can enhance the efficiency and safety of our surgical procedures, ultimately leading to better patient outcomes.

The National Association of Medical Device Representatives (NAMDR) is committed to looking beyond the past and focusing on how we can advance patient safety and surgical outcomes in the future. Our goal is to collaborate with leading organizations such as AORN, The Joint Commission, ACS, and AMA to update and revise existing guidelines to reflect the evolving realities of surgical tray management and surgical case setup. By integrating the latest best practices and acknowledging the critical role that medical device representatives play in these areas, we can collectively enhance the safety, efficiency, and overall success of surgical procedures. NAMDR is eager to work alongside these esteemed organizations to ensure that our healthcare standards are not only maintained but also improved to meet the demands of modern surgical practices.

Join Us in Advocating for Change

NAMDR is dedicated to preserving the integrity and excellence of the medical device representative profession through unwavering commitment to education and prioritizing patient well-being over profits. We invite healthcare professionals, policymakers, and industry stakeholders to join us in advocating for these essential changes. Together, we can ensure that the presence of MDRs in the operating room enhances, rather than jeopardizes, patient care.

For more information on our initiatives and how you can get involved, please visit our website or contact us directly.

About NAMDR

At the National Association of Medical Device Representatives (NAMDR), our mission is to empower our members with cutting-edge knowledge, foster a culture of ethical practice, and ensure the highest standards of patient care. By championing continuous learning and ethical responsibility, we strive to uphold the trust and respect of the healthcare community, ultimately improving patient outcomes and advancing the medical device industry.

Contact Us

Email: [email protected] Website: www.namdr.org

Together, we can create a safer, more transparent, and effective healthcare environment.

References:

1. AORN Position on HCIRs: Association of periOperative Registered Nurses (AORN), Position Statement on the Role of the Health Care Industry Representative in Perioperative Settings. Link to document
2. AMA Position on Industry Representatives in Clinical Settings: American Medical Association (AMA), Code of Medical Ethics Opinion 10.6, “Industry Representatives in Clinical Settings.” Link to document
3. ACS Revised Statement on HCIRs in the Operating Room: American College of Surgeons (ACS), Revised Statement on Health Care Industry Representatives in the Operating Room, October 1, 2016. Link to document
4. The Joint Commission’s Standards for Non-Licensed, Non-Employee Individuals: The Joint Commission, Standards Interpretation, “Non-licensed, Non-employee Individuals - Human Resource Requirements,” Last reviewed April 19, 2022. Link to document