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Healthcare Industry Representative (HCIR)
NO Certification requirement for Medical Device Representatives who set up Surgery and attend Surgery.
Vendor Credentialing is a Voluntary ANSI guideline 90% of the Hospitals today follow. This was established by industry without the guidance of Public Health. It starts with the term HCIR.
Association of National Electrical Manufacturers Association, Consortium for Universal Healthcare Credentialing (C4UHC) have designated the term Healthcare Industry Representative (HCIR). The following are considered HCIR’s:
• Clinical Education Specialist
• Home Care Provider
• Social Services
• Supplier Sales Representative
• Bio-Medical Technician
• Mortician
• Construction Worker
• Delivery Personnel
• Non-employee Maintenance
• Contract Lobor
• Supplier Executive
• Hospice Staff
• Durable Medical Equipment Staff (DME)
HCIR
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The term designated to describe Representatives that visit Hospitals and have the potential to attend surgery as described in the document ANSI/NEMA SC1-2020:
“ACCESS TIER 3 or “Level 3” – Defined as sterile or restricted areas where non-employee access is allowed, but supplier representatives or non-employee is required to have specific healthcare provider permission and may require oversight by medical staff and administration.
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E.g., Procedural patient care spaces such as operating rooms or catheterization labs.”
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ANSI/NEMA SC1-2020 Page 4
THERE IS NO MENTION OF STERILE PROCESSING WHERE A MEDICAL DEVICE REPRESENTATIVE (MDR) STARTS THE PROCESS TO SETUP UP TRAYS OR SETS FOR SURGERY.
Vendor Credentialing
Established by the Association of National Electrical Manufacturers Association, Consortium for Universal Healthcare Credentialing (C4UHC) and 47 Voting Members of Committee.
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Due to copywrite of document ANSI/NEMA SC1-2020 we are unable to share the document however it can be purchased/downloaded via the button below.
While Ansi Approved the Standard for Vendor Credentialing with the approved ANSI/NEMA SC 1-2019, ANSI/NEMA SC 1-2020 is titled the American National Standard for Supplier Credentialing in Healthcare. The document remains unclear as to a guideline or Standard. The document states the following:
“There are some accreditation organizations’ Standards that apply to all individuals in a healthcare provider facility. However, because there are currently no national Standards, laws or regulations, healthcare providers have their own requirements and processes. As a result, to credential their employees (supplier representatives), Suppliers shall engage in duplicative efforts with no tangible benefit and at a high cost to the United States healthcare system. In addition, supplier representatives may be subjected to equal or sometimes greater scrutiny thasn healthcare provider employees, even though supplier representatives have minimal to no direct contact with patients. Moreover, suppliers and supplier representatives are often required to send sensitive personal data to many third parties.”
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ANSI/NEMA SC1-2020 Page iii
Due to copywrite issues we can only provide the link below.
MEDICAL DEVICE REPRESENTATIVES – Are currently NOT CERTIFIED however they SELL > ARRANGE LOGISTICS > SETUP FOR SURGEY > ATTEND SURGERY > BILL THE HOSPITAL for instruments, implants, and device used.
MDR
Hospital
Manufacturer
While not a hospital employee they are a liaison between the Hospital and the manufacturer. An MDR can be a W2 or a 1099 employee; today we are seeing a mix of both.
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This creates the following issues:
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Does a hospital truly know if the MDR is truly educated on the product it represents?
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What insurance covers the W2 or 1099 for the product used?
The Role of the Medical Device Representative is not clearly defined.
State and National Standards and Processes have not been established. It is the goal of the National Association of Medical Device Representatives (NAMDR) along with the National Board of Certified Medical Device Representatives (NBCMDR) to work with the Department of Public Health to move forward and make this profession Patient Safe. Educational requirements and Certification need to be a standard for patient safety. Certification holds individuals to a higher standard.
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The Surgical Team of Surgeons, Anesthesiologists, Nurses, Surgical Technicians and in some states Central Processing Technicians are required to be Certified. DME (Durable Medical Equipment such as wheelchairs, braces, crutches) requires certification to be sold.
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However, Medical Device Representatives who sell, Pacemakers, Hips, knees, spine, and orthopedic implants... set up, attend surgery, and have a direct impact on the surgery are not required to be Certified.
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Certification holds an individual to a higher level. Proper education is needed along with CME education.
The Following ASSOCIATIONS acknowledge HCIR’s in the Operating Room but do not mention the FACT Medical Device Representatives setup for the Surgery they attend...
1.5 Billion is the estimated Cost to Healthcare – which has already been incurred by the system…
Currently, there are Multiple Vendor Credentialing companies.
Currently, there is no single Certification, Standard/Process, or single Hospital Vendor Passport for Vendor access. Below is the estimated cost to Healthcare from the Consortium for Universal Healthcare Credentialing.
Reference Information - 2015 updates
Reference 1
$1.5 Billion - Cost to the industry considering 60% utilization
Assumptions:
(1) 90+% of HCOs apply credentialing requirements
(2) 5,754 hospitals, American Hospital Association statistic
(3) Estimated 500,000 - HCIRs in Vendor Credentialing Systems nation-wide
(4) Estimated labor efforts​
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240 hours per hospital/campus/year to manage a compliant program
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40 hours per year - average time HCIR spends on credentialing based on industry surveys
(5) $- is the average annual expense per HCIR in fees and medical testing
(6) Bureau of Labor Statistics job codes
a. 41-4011 fully burdened salary
b. 12-1023 fully burdened salary
(7) Cost estimates do not include staff training, system implementations, or administrative overhead
Medical Device Representatives and companies must pay for multiple Vendor Credentialing companies as there is no National Standard. We believe this has already increased the cost of Health Care by the established and Hospital accepted Vendor Credentialing.
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Our Concern at the NBMDR is that hospitals have been told and accepted Vendor Credentialing as a National Standard for HCIRs with no mention of the subset of HCIRs that are Medical Device Representatives (MDR). Currently, there are no National, State Local Definitions of the responsibilities of a Medical Device Representative. Currently, no standards or processes exist for Medical Device Representatives who are not only in the Surgical suites of Hospitals and Surgery centers but also arrange logistics and setup for the surgery they attend. While Medical Device is highly regulated, amazingly, MDRs who sell pacemakers, to hips and knees are not required to be certified but DME salespeople who sell crutches, braces, and wheelchairs are. Even Pharmaceutical Representatives are required to be CNPR Certified.
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We question if Public Health is aware of the significant role MDRs play in Public Health.
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​NAMDR and NBCMDR wants to move forward learn from the past and collaborate to define and educate safe standards.
How NON-Certified Medical Device Representatives Currently Setup for Surgery
Currently, Non-Certified Representatives set up and attend surgery! The ANSI NEMA SC 1-2020 discusses Class 3 HCIRs who need access to sterile procedure areas – specifically OR Surgery, Cardiac Cath Labs.
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There is no mention of Central Processing where Medical Device Representatives check in surgical trays for surgery. This has gone on for years…
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Certification and CME education is required and must be the Standard.
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We at the NAMDR ask the question is and has this been a patient safe solution? While we are not interested in looking backward, we do want to move forward and do the following:
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Find a Patient Safe Solution
Define the Role of the Medical Device Representative
Set the Standard and Process to follow Nationally
We would like to work with Public Health at the State and Local Levels to finish what Vendor Credentialing did not achieve.
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We hope the following associations can support our efforts:
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Department of Public Health
The Joint Commission
DNV
How instruments arrive for surgery – Why education and Certification must be a requirement!
Patient Safety – infection prevention…
A MDR sets up for either LOANER or Consignment Surgery
This is a sample setup form used by most hospitals for an MDR to set up loaner/consignment cases for the surgery they will attend.
Loaner surgery – instruments/implants/devices are borrowed from a manufacturer (on loan) for a single or multiple surgical cases at a hospital or surgery center. Then returned to the manufacturer. MDR will bill the hospital for the items used.
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​Consignment - instruments/implants/devices are borrowed from a manufacturer (on loan) for a set period to be used and stored at a hospital or surgery center. MDR will bill the hospital for the items used.
Is there a link between loaner surgery and higher infection rates?
Multiple Medical Device Representatives attending Surgery.
We at the NAMDR have a Patent Pending Telehealth solution to help reduce the number of people in the surgical suite from the MDR perspective.
“Several studies have stated that an increased number of people in the OR increases not only the risk of infection but also the risk of intraoperative complications due to distractions during the surgery.”