Place a Device on Four Axes Before Naming Its Category
Device Classification Worksheet
Companion to Medical Device Connectivity · Updated 2026-09-29
Use this before you evaluate or buy a device, to place it by who governs it and what it produces. Healthcare technology management (HTM), procurement, and the clinical or process owner fill it in together; “Personal and Institutional Devices Need Different Things” works it on the automated probe reprocessor. Use it the same way for any institutional device class, from an ultrasound system or a blood gas analyzer to a surgical robot, an infant incubator, or a patient lift.
Answer the three governance questions first. Then place the device on each axis. Choose the category last. Bring the department that runs the device into the room. For example, bring the laboratory for an analyzer, pharmacy for a dispensing cabinet, imaging for a scanner, and sterile processing for a washer-disinfector.
The Device Classification Worksheet: place the device on the four axes first, and name its category last as a summary of them.
| Field | What to record | Entry |
|---|---|---|
| Device | The device as the institution will know it: type, model, and the software version under evaluation | |
| 1. Who primarily operates the device? | The role that runs it day to day (patient, nurse, respiratory therapist, radiologic technologist, perfusionist, dialysis technician, pharmacy technician, sterile-processing technician, laboratory staff) | |
| 2. Whose workflow does it participate in? | The workflow and the person who owns it (medication dispensing, imaging, specimen testing, dialysis treatment, patient monitoring, endoscope reprocessing, instrument sterilization) | |
| 3. Who bears the operational consequence? | Who carries the result when the device fails, disconnects, can’t be located, can’t be updated, or can’t prove what it did | |
| Axis A: operational locus | One of: person-governed, clinician-governed, institution-governed | |
| Axis B: role | All that apply: observe, recommend, act or treat, execute a clinical process, maintain or assure clinical infrastructure | |
| Axis C: failure consequence | All that apply: inconvenience, delayed information, workflow disruption, diagnostic error, therapeutic error, patient harm, compliance or traceability failure, institutional downtime | |
| Axis D: primary digital artifact | The main one: physiological signal, patient-reported data, therapeutic action, operational event, assurance evidence | |
| Where it operates | Hospital unit, operating room, imaging suite, dialysis unit, pharmacy, clinic, sterile processing, laboratory, or the patient’s home. Location is recorded, but it never decides the category. | |
| Category | One of: Personal Signal Device, Institutional Observation Device, Institutional Action Device, Institutional Process Device |
When the axes and the category seem to disagree, go with the axes: an institution-issued monitor in a patient’s home is still institution-governed. The axes place three devices that the chapters don’t work in detail as follows:
- Chemistry analyzer: institution-governed; observes; produces specimen results. An Institutional Observation Device.
- Hemodialysis machine: clinician-governed; treats; produces a record of the treatment it delivered. An Institutional Action Device.
- Medication refrigerator: institution-governed; maintains clinical infrastructure; produces a temperature record that proves storage was safe. An Institutional Process Device.
Any institutional category puts the device under the No Connectivity, No Purchase presumption. If you can’t place a device on all four axes, don’t evaluate it yet: nobody knows who owns its failures.