Medical Device Rep: OR & Hospital Knowledge

01Sterile field & OR etiquette

Reps stay outside the sterile field at all times and never touch the patient or sterile instruments. In most facilities reps do not scrub in; their role is to support verbally from outside the field — communicating with the scrub tech, opening implant packaging from a non-sterile position, and giving technical guidance without touching sterile items themselves.

02Vendor credentialing

Hospitals require device reps to be credentialed before entering clinical areas — verifying immunizations, background checks, and completed product/compliance training (OR protocol, HIPAA, adverse-event reporting). This controls facility access and is separate from any FDA requirement on the device itself.

03FDA device classes I, II, and III

Class I devices (e.g., elastic bandages, exam gloves) are lowest-risk and need only general controls. Class II devices (e.g., infusion pumps, surgical drapes) are moderate-risk and need general plus special controls. Class III devices (e.g., replacement heart valves, implanted stimulators) are highest-risk, life-sustaining or implantable devices requiring the most rigorous review.

04510(k) vs. PMA

A 510(k) submission shows a device is substantially equivalent to an already-marketed predicate device — most Class II devices use this faster pathway. A PMA (Premarket Approval) requires clinical evidence proving reasonable assurance of safety and effectiveness on its own — most Class III devices require this more rigorous pathway.

05Value Analysis Committees (VAC)

A VAC is a multidisciplinary hospital group (physicians, nurses, supply chain, finance, risk) that reviews new products before they can be purchased or used, weighing clinical value, safety, and financial impact against existing options — not just whether the device is FDA-cleared.

06GPOs and how hospitals buy

A Group Purchasing Organization (GPO) negotiates supply contracts on behalf of many member hospitals by pooling purchasing volume for better pricing. Even after VAC approves a device clinically, it may still need to fit within (or get an exception to) the hospital's existing GPO contract to actually be purchased.