Module guide · Operations

Equipment

A registry of every biomedical asset drives everything else: scheduled maintenance and calibration, custody checkouts, incident/adverse-event reporting with FDA MedWatch filing, manufacturer recalls, and a vendor directory.

Overview Dashboard Asset registry Asset detail Maintenance Checkouts Incidents Recalls Vendors Reports Import/export Good practices

What this module is for

A broad clinical/admin group can view and work most of the module; the Vendors directory and bulk Import/Export are management-only.

Who uses it

Nurses, physicians, IT admins, nurse managers, charge nurses, safety officers, quality, compliance, department heads, directors, and admins can register assets, schedule maintenance, check equipment in/out, and report incidents/recalls. Vendors and Import/Export are limited to safety officers, quality, compliance, department heads, directors, and admins.

Where to find it

Open Equipment from the sidebar. A dashboard, plus Asset Registry, Maintenance, Checkouts, Incidents, Recalls, Vendors, Reports, and Import/Export.

1
Register the asset
Tag, category, manufacturer, department, risk level, and PM/calibration/electrical-safety intervals if it needs them.
2
Keep it maintained
Preventive, corrective, calibration, and safety-test work orders run against the PM interval you set.
3
Track custody
Check equipment out to a staff member or patient with a due-back time; overdue loans surface as their own worklist.
4
Respond to problems
Log incidents (with FDA MDR filing if a patient was harmed) and manufacturer recalls, then close them out with root cause and remediation.

A few terms you'll see throughout

PM is preventive maintenance. MDR is an FDA MedWatch Medical Device Report, filed when a device incident involved patient harm. A Class I recall is the FDA's most serious tier, reasonable probability of serious harm or death.

Dashboard

A fleet-wide command center: counts, financials, and open compliance alerts.

Stat tiles

Field	What it means
Total Assets, In Use, Available, Under Maintenance
Quarantined, Missing, Decommissioned
Compliance Flags	Sum of overdue PM, calibration, electrical-safety tests, open recalls, open sentinel events, and unfiled MDRs. Red if greater than zero.
Total Asset Value, Maintenance Cost YTD, Active/Overdue Checkouts

Up to 10 open Compliance & Safety Alerts are listed with severity, equipment, and message, each clicking through to that asset.

Asset registry

The searchable master list of every biomedical asset the hospital owns.

Filters

Field	What it means
Search, Status, Category, Department, Risk Level
PM Overdue, Calibration Overdue, Warranty Expiring Soon	Checkbox toggles.

"Register Equipment" form

Field	What it means
Asset Tag, Equipment Name, Category, Manufacturer*
Serial Number, Model Number, UDI-DI, Description
Department, Location Detail, Vendor, Assigned Staff
Purchase/In-Service Date, Purchase Cost, Warranty Expiry
PM Interval (days), Risk Level	Risk defaults to Medium.
Requires periodic calibration, Requires electrical safety test (NFPA 99)	Checkboxes; each reveals its own interval field.
Mobile asset, Shared asset, Notes

Available —

In Use / Reserved —

Under Maintenance / Awaiting Repair —

Quarantined / Missing —

Decommissioned —

Asset detail

One asset's full file: identification, custody, compliance schedule, and five history tabs.

Tabs

Field	What it means
Overview	Identification, location/custody, lifecycle/financials, and the PM/calibration/electrical-safety compliance schedule. Edit and Decommission (reason required, irreversible from the UI) live here.
Maintenance	This asset's work-order history, with Schedule Work Order and Start/Complete actions.
Checkouts	Custody history, with Check Out (only while Available and not already checked out) and Return.
Incidents	This asset's malfunction/adverse-event log, with Report Incident, File MDR, and Close with CAPA.
Recalls	This asset's recall history, with Register Recall, Acknowledge, and Mark Remediated.
Status History	Read-only timeline of every status change, who made it, and why.

Maintenance

The fleet-wide work-order queue: preventive, corrective, calibration, and safety-test jobs.

"Schedule Work Order" form

Field	What it means
Equipment, Type, Scheduled Date*	Type: Preventive, Corrective, Regulatory Inspection, Recall Remediation, Electrical Safety Test, Calibration, Software Update, Performance Verification, Decontamination, Incoming Inspection, or Decommission.
Technician, Vendor Name, Vendor Ticket #, Problem Description, Notes

Lifecycle: Scheduled → Start → In Progress → Complete. Completing requires Work Performed, and captures parts/labor cost, a test result, a certification number, the next due date, downtime, and whether follow-up is required.

Checkouts

Custody tracking, with the fleet-wide screen focused on chasing down overdue loans.

"Check Out Equipment" form

Field	What it means
Equipment, Checked Out By, Due Back*
Patient, Destination Department, Purpose, Condition Out, Notes

Returning requires who received it back and its Condition In. The fleet-wide Checkouts screen lists only currently-overdue loans as a follow-up worklist, with a Return button per row.

Incidents

Malfunctions and adverse events, with sentinel-event flagging and FDA MedWatch (MDR) filing.

"Report Incident" form

Field	What it means
Equipment, Incident Date/Time, Title, Description, Severity, Type*	Severity: Low, Moderate, High, Critical. Type: Malfunction, Near Miss, Adverse Event, Property Damage.
Patient Involved, Patient harm occurred	Checking harm reveals a required Patient Harm Description field.
In use at time of incident, Sentinel event	Checkboxes; "in use" defaults checked.

File MDR appears only once patient harm is recorded; Close with CAPA requires a Root Cause and CAPA Actions before the investigation can close.

Recalls

FDA and manufacturer safety recalls, acknowledged and remediated per asset.

"Register Recall" form

Field	What it means
Equipment, Recall Class, Title, Reason, Issued Date*	Class I is the FDA's most serious tier.
FDA Recall #, Manufacturer Ref #, Required Action, Response Deadline
Remove from service immediately	Checkbox.

Lifecycle: Open → Acknowledge → In Remediation → Mark Remediated (requires a Remediation Description). Class I recalls are highlighted red throughout.

Vendors

The biomedical service-provider directory, management-only.

"Add Vendor" form

Field	What it means
Vendor Name*
DBA Name, Tax ID, NPI
Primary Contact (name/phone/email), Support/Emergency Phone, Support Email, Address
Service Types, Authorized Brands	Comma-separated lists.
Emergency Response SLA (hours), Routine Response SLA (hours)
Preferred vendor	Checkbox, shown as a star on the vendor card.

Each vendor card shows how many registered assets are linked to it, a quick view of dependency.

Reports

Fleet-wide analytics: composition, compliance posture, and cost trends.

Panels

Field	What it means
Compliance stat tiles	PM/Calibration/Elec. Safety Overdue, Unfiled MDRs (30d), Open Recalls, Open Sentinel Events, Warranty/Contracts Expiring (90d), all red-highlighted when nonzero.
Maintenance Cost Trend (12 mo)
Fleet by Status, Category, Risk Level	Bar charts.
Full compliance alert list	Every open alert, untruncated (unlike the dashboard's top-10).

Per-asset maintenance history can be exported to CSV from here by searching the asset, or from the asset's own Maintenance tab.

Import/export

Bulk CSV registry operations, management-only.

Download Template gives the expected columns; Choose CSV File imports immediately on selection and reports imported/skipped/error counts, with a per-row error table when something fails. Export Equipment CSV downloads the full registry.

Good practices

Set PM and calibration intervals at registration, not later

The Compliance Flags tile and every overdue report depend on those intervals being set from day one.

Chase overdue checkouts from the fleet-wide Checkouts screen

It's scoped to just what's overdue, a faster worklist than filtering the full custody history per asset.

File the MDR as soon as patient harm is confirmed

It only becomes available once harm is recorded on the incident, and FDA MedWatch reporting has its own regulatory timeline.

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