.png)
National Association of Medical Device Representatives
Unmet Need in Medical Device Representative Certification
In today's healthcare landscape, hospitals and other medical facilities contract with non-hospital employees known as Healthcare Industry Representatives (HCIRs) to set up and attend surgeries. A specialized subset of these HCIRs, called Medical Device Representatives (MDRs), perform crucial functions in surgical environments. Despite their significant role, there is currently no mandatory certification requirement for MDRs.
Current Standards and Their Limitations
Healthcare organizations independently manage policies regarding HCIRs, who are recognized as non-hospital employees. The ANSI/NEMA SC 1-2020 standard is the primary guideline for vendor credentialing, outlining access requirements for Tier 1, 2, and 3 locations. MDRs, given their specialized functions, are permitted access to Tier 3, allowing entry into sterile areas within healthcare facilities.
​
However, the ANSI/NEMA SC 1-2020 standard focuses solely on vendor access and does not address specific guidelines or standards for MDRs in their roles of setting up and attending surgical procedures. This gap in regulation underscores a critical unmet need identified by the National Association of Medical Device Representatives (NAMDR), particularly concerning patient safety.
The Certification Gap
Presently, certification is required for Pharmaceutical Representatives and Durable Medical Equipment (DME) representatives (such as those dealing with wheelchairs and bone stimulators). Yet, no such certification exists for MDRs who deal with high-risk devices like pacemakers, human tissue, and orthopedic implants, despite their direct involvement in surgical settings.
​
Medical device companies typically focus on educating representatives about product usage and sales techniques. However, there is a lack of formal education and certification regarding surgical case setup and tray management—a significant patient safety issue considering these representatives are non-hospital and non-certified employees.
NAMDR's Proposed Solution
To address these critical gaps, NAMDR proposes the following enhancements to the current system:
-
National REP™ Registration Number: to link the multiple Vendor Credentialing systems together.
-
HCIR Certificate: In line with ANSI/NEMA SC 1-2020 standards.
-
Certified Medical Device Representative (CMDR) Certification: A new certification specifically for MDRs.
These certifications aim to integrate seamlessly into existing Vendor Credentialing systems without imposing additional costs on healthcare facilities. By establishing rigorous certification standards and updating educational requirements, NAMDR seeks to ensure that MDRs contribute positively to patient outcomes and uphold the highest standards of professionalism and safety.
Future Vision
The certification for Medical Device Representatives is a recent development, and NAMDR's initiative represents a forward-thinking approach to enhancing patient safety and care quality. By paving the way for a future where Certified Medical Device Representatives operate within a well-defined, safe, and impactful framework, NAMDR aims to foster excellence and collaboration in the medical field.
​
The proposed certifications will ensure that MDRs are well-equipped to handle the complexities of surgical environments, ultimately leading to better patient outcomes and a safer healthcare system. Through these efforts, NAMDR aspires to set a new standard in the medical device industry, prioritizing patient safety and professional integrity above all.
Currently, healthcare organizations operate with independent policies regarding how Healthcare Industry Representatives (HCIRs) function within their facilities. Vendors are identified as non-hospital employees, and the ANSI/NEMA SC 1-2020 standard is the only guideline for Vendor Credentialing, addressing vendor access requirements for Tier 1, 2, and 3 locations. Medical Device Representatives (MDRs), a subset of HCIRs, are classified as Tier 3, granting them access to sterile areas within healthcare facilities. While ANSI/NEMA SC 1-2020 focuses on vendor access to facilities, it does not provide guidelines or standards for Medical Device Representatives who set up and attend surgical procedures as non-hospital employees. The National Association of Medical Device Representatives (NAMDR) recognizes this unmet need, emphasizing a focus on patient safety.
​
Currently, there are certification requirements for Pharmaceutical Representatives and Durable Medical Equipment (DME) representatives (wheelchairs, bone stimulators). However, there are no certification requirements for Medical Device Representatives who sell devices like pacemakers, human tissue, hips, and knees, despite their significant role in healthcare facilities, including setting up and attending surgeries. This gap highlights the need for specific standards and certification processes to ensure the safety and efficacy of medical device representatives' involvement in surgical procedures. While medical device companies may focus on education related to sales and proper use, today there are no requirements and education for surgical case setup and tray management. This is a significant patient safety issue for non-hospital and non-certified employees managing inventory, and reporting outcomes ensure ongoing support and continuous improvement.
​
Proper procedures for removing surgical trays from healthcare facilities ensure decontamination, secure packaging, and accurate documentation. Loaner surgery trays must be removed within 48 hours, while consignment trays should be restocked within 24 hours.
By choosing NAMDR-certified MDRs, customers are assured of quality and reliability, with highly trained and certified representatives adhering to stringent standards. Commitment to the highest standards of patient care and safety, ethical conduct, and professional behavior in all interactions, full compliance with relevant regulations and guidelines, and streamlined processes for surgical tray management, human tissue handling, and post-surgery responsibilities are guaranteed. Investing in NAMDR-certified Medical Device Representatives means partnering with professionals who are committed to excellence, safety, and ethical practices. Our guidelines ensure that MDRs are well-prepared to support healthcare facilities effectively, contributing to improved patient outcomes and operational efficiency.
​
Healthcare organizations currently follow independent policies for Healthcare Industry Representatives (HCIRs) within their facilities. Vendors are recognized as non-hospital employees, guided by the ANSI/NEMA SC 1-2020 standard, which outlines vendor access requirements for Tier 1, 2, and 3 locations. Medical Device Representatives (MDRs), a subset of HCIRs classified as Tier 3, have access to sterile areas within healthcare facilities. However, ANSI/NEMA SC 1-2020 does not provide specific guidelines or standards for MDRs who set up and attend surgical procedures. The National Association of Medical Device Representatives (NAMDR) sees a significant unmet need here, emphasizing patient safety.
Currently, certification requirements exist for Pharmaceutical Representatives and Durable Medical Equipment (DME) representatives, but not for Medical Device Representatives who sell critical devices like pacemakers, human tissue, hips, and knees. This lack of certification highlights the need for standards to ensure MDRs' involvement in surgical procedures is safe and effective. Medical device companies focus on sales and proper use education, but there are no standardized requirements or education for surgical case setup and tray management, posing a significant patient safety issue for non-hospital and non-certified employees.
The National Association of Medical Device Representatives (NAMDR) is committed to excellence, safety, and ethical practices, ensuring improved patient outcomes and operational efficiency.
Guidelines Provided by NAMDR
These guidelines can be implemented in part or whole for Healthcare facility policy or educational requirements to existing Vendor Credentialing.
Guideline to Define the Role of a Medical Device Representative
Guidelines for Medical Device Representatives: Certification and REP Number Requirement
Post-Surgery Guidelines for Medical Device Representatives (MDRs)
Guidelines for Surgical Tray Removal from a Healthcare Facility
Educational Guideline for Certified Medical Device Representative (CMDR) Certification
Guideline on Separation and Use of Medical Devices for Cadaver Procedures
Guideline for Medical Device Representatives Bringing Custom Instruments for Surgical Cases
Guideline on Managing Medical Device Representative Consignment Stock (Trunk Stock)
Telehealth Guidelines for Medical Device Representatives (TeleREP) Attending Surgeries
Guideline for Medical Device Representatives Managing Sterile Packaged Implants
Guideline for Medical Device Representatives and Personal Protective Equipment (PPE)
Guidelines for Medical Device Representatives: Attendance and Roles During Surgical Cases
Guideline on Medical Device Billing for Medical Device Representatives
Guideline on Instructions for Use (IFU) Registry for Medical Device Representatives
Guideline on Implant Removal Registry
Guideline for Medical Device Representative Apprenticeship Program
Guideline for Medical Device Representative Mentor Program
Guideline for Healthcare Facilities to Allow Clinical Observation for Medical Apprenticeships
Guideline for National VAC Submission Process for Hospital Vendors
Guidelines for Hospital Vendor Credentialing: Reporting Requirements to Patient Safety Organizations (PSOs)
Social Media Guidelines for Medical Device Representatives in Healthcare Facilities
Guideline for Medical Device Incident Reporting and MAUDE Filing
Guideline for Medical Device Implant Record and Traceability for Implants, Human Tissue, and Biologics
Guidelines for Medical Device Representatives Conducting Sales Activities in Healthcare Facilities
Guidelines for Medical Device Representatives: Submitting to the Hospital Value Analysis Committee (VAC)
Guidelines for Medical Device Representatives (MDR): "By Invitation Only" Access to Healthcare Facilities
Guidelines for Medical Device Representatives: Educating the Surgical Team Post-VAC Approval and Invitation Process
Guidelines for Medical Device Representatives (MDR): Surgical Tray Management
Guidelines for Medical Device Representatives: Ready For Surgery Process
Guidelines for Medical Device Representatives Managing Human Tissue
Guidelines for Transmission Control for Medical Device Representatives
Guidelines for Medical Device Representatives on Medical Device Coding for Reimbursement
Guideline for Hospitals Using Accredited Vendor Credentialing to a National Standard