Walk into any of your ORs during a total joint procedure tomorrow morning and look around the table.
The surgeon is licensed, credentialed, and privileged. There’s a defined list of what they may do in your facility, anchored to verified qualifications. Your anesthesia providers, nurses, and surgical technologists practice under the same architecture.
Then there is the healthcare industry representative—the person whose technical guidance shapes how the implant system, the navigation platform, or the robot is used in this patient. That person stands in your restricted environment under a different system entirely: vendor credentialing that verified documents and granted access.
So everyone at the table is verified for what they do—except the person guiding the technology.
This is not a criticism of vendor reps, many of whom are deeply experienced and rigorously trained by their manufacturers. Rather, it is an observation about architecture.
Product knowledge is not job competency in a healthcare environment. Currently, no license, no privileges, and no accredited portable certification attests to the rep’s competency for your surgical workforce.
This gap belongs to the system, not to the individuals working inside it. Operationally, however, it lands on you as the perioperative leader.
Perioperative leaders already know the tools available today, because you enforce them. Vendor credentialing—now standardized under ANSI/NEMA SC 1-2020, the American National Standard for supplier credentialing—verifies identity, immunizations, background screening, training attestations, and insurance, and organizes access around facility tiers. It solved a real problem, and it did what it was scoped to do.
But look at what the tiers actually are: a map with no destinations. SC 1-2020 defined where a representative may go—public areas, patient care areas, restricted and procedural environments. However, no standard has ever defined the work that is performed in each of those places or the competency each task requires.
Credentialing answers the question “May this person enter, and where?” But it has never answered the question “What is this person qualified to do once inside?”
The clinical side of the room shows why that second question matters. A license means something because a defined scope of practice sits underneath it; privileges mean something because they delineate a specified body of work. Document verification without an underlying task definition establishes eligibility to enter a building—but it does not establish readiness to perform the work.
Even the consensus standards that touch this workforce leave a seam. ASTM F565, the standard practice for care and handling of orthopedic implants and instruments, enumerates hospital receiving personnel, central supply, OR personnel, and surgeons—but expressly excludes producer-level handling from its scope.
The individual who transports the loaner set, reconciles it against the manifest, delivers the processing instructions your SPD depends on, and returns to support the case appears in the standards literature as a residual clause: “occasionally other individuals.” A share of the handling your schedule depends on every day is performed by a role that exists as a footnote.
Consider an ordinary week in surgical services. Loaner sets for Monday’s spine case arrive Sunday night, received by a shift that was not told they were coming. Sterile processing calls at 5:40 a.m. because one tray’s IFU cannot be located and the count sheet describes a different revision of the set. The representative covering the morning case is not the one who delivered the trays, because coverage changed overnight, and everything the first person knew about those specific sets exists in their head and their text messages. A borrowed set from across town appears at the dock with no record of when it was decontaminated, or by whom.
None of these people failed. Each was doing their job as the current system defines it—which is to say, as no system defines it.
When something goes wrong, it does not land in the manufacturer’s data. Surgical site infections are counted, publicly reported, and reflected in payment and ratings. Whether the implant trays arrived in time to be processed properly appears in no measure anywhere. The outcome is measured to two decimal places, while the inputs are not measured at all.
Under the CMS Conditions of Participation, the governing body answers for services furnished under contract or arrangement, and the QAPI [Quality Assurance and Performance Improvement] program must analyze the failures. Operationally, that means perioperative leadership absorbs the risk of a role it never defined and cannot verify.
Every answer we can currently get about the readiness of the vendor rep workforce takes the same form. “Trained,” says the manufacturer. “Ready,” says the employer. “Experienced,” says the representative. These are attestations—declarations made by parties with an interest in the answer. They may all be true, but healthcare accepts attestation from no one else at the table.
Attestation declares competence. Certification tests it through an independent third party against a standard everyone can read.
Professions solve this problem the same way every time—with a job task analysis (JTA). This is the accepted research method for establishing what a role actually consists of, including the discrete tasks performed, the knowledge and skills each requires, and the competencies expected of an entry-level practitioner. It is the evidence base under every credible certification exam and competency framework in healthcare, revalidated on a defined cycle.
Perioperative nursing has one. Surgical technology has one. Sterile processing has one. The workforce that moves manufacturer-supplied devices into and out of our procedural environments has never had one.
That is now changing. The Healthcare Workforce Access Standards Commission (HWASC), a standards developer accredited by the American National Standards Institute (ANSI), has launched the National Healthcare Industry Representative (HCIR) Job Task Analysis initiative to define, for the first time, the role of the healthcare industry representative—the non-hospital professional who accesses healthcare facilities to perform service work in support of patient care.
The clearest example is the medical device representative who takes the surgeon’s order, arranges the loaner sets, delivers them, supports setup, and provides technical guidance on the products during the case. The JTA convenes a balanced panel of subject matter experts to draft the task inventory, followed by a national practitioner survey that rates each task for frequency, criticality, and consequence of error.
The validated inventory is intended to serve as the foundation for accredited, portable personnel certification under ISO/IEC 17024—the same species of instrument the rest of the perioperative team already practices under.
A validated task inventory has standalone value for a perioperative leader regardless of what follows it. It is something you can write vendor policy against, orient new representatives against, structure competency conversations around, and answer a surveyor with.
Today, every facility answers the “what may this person do” question alone, differently, at every door. A national definition replaces a thousand local improvisations.
Here is the part that should concern perioperative leaders most: a JTA is only as credible as the panel that conducts it. Manufacturers can describe how representatives are trained. Representatives can describe what they do. But only the people who run perioperative departments observe the entire arc—the request, the arrival, the processing, the case, the return—across every vendor, every service line, and every shift. The perioperative manager possesses the singular vantage point from which the whole timeline is visible.
If perioperative leaders do not help define this role, the definition will still be written, predominantly by the parties who already attest to it. That would reproduce exactly the weakness the effort exists to cure. Balance requires the facility’s voice, and in the procedural environment, the facility’s voice is that of perioperative leadership.
Perioperative leaders have spent decades professionalizing everything within their walls: credentialing, competencies, counts, time-outs, structured handoffs.
The last undefined role in the surgical environment is not inside those walls. It walks through them, several times a day, carrying the trays upon which the surgical schedule depends. Defining that role is overdue, and it is finally happening. It will be better if the people accountable for the room are in the room where it is written.
The National HCIR Job Task Analysis is conducted as an independent, psychometrically guided subject matter expert process. Perioperative leaders who are interested in serving as Founding Subject Matter Experts can email info@hwasc.org with the subject line “Founding Subject Matter Expert Application,” or visit the HWASC website to learn more. Participation is open to all directly and materially affected parties.
Peter Daigle is executive director of the Healthcare Workforce Access Standards Commission (HWASC), a standards developing organization accredited by the American National Standards Institute (ANSI). HWASC develops voluntary consensus standards addressing workforce access, competency, and patient safety at the interface between medical device manufacturers and healthcare facilities. Contact Mr. Daigle via email at info@hwasc.org.
