Biomedical equipment records: what they must contain

A biomedical equipment record is not a form you fill in and file away. It is the evidence that the equipment was maintained, by whom and when. In a licensing visit, it is the first thing they ask for.

What it must contain

Without quoting resolution numbers, licensing in Colombia requires you to demonstrate documented maintenance. In practice, a complete record carries:

• Identification: name, brand, model, serial number, health registration and internal asset number.
• Location and owner: service, site, and who is responsible for the equipment today.
• Technical data: voltage, power, risk classification and the accessories that go with it.
• Acquisition date, supplier and warranty status.
• Maintenance programme: preventive jobs with their frequency, and every corrective job performed.
• Calibrations and verifications, with the certificate attached where applicable.
• Event log: failures, transfers, decommissioning and component replacements.

Why the spreadsheet falls short

A spreadsheet does not fail on capacity, it fails on traceability. When the auditor asks who signed off the March preventive and with which spare part, a shared file cannot answer: anyone could edit any cell at any time and nothing is recorded.

On top of that comes the practical problem: the technician is at the client site, not in front of a computer. If the report is filled in three days later from memory, the document date and the work date do not match, and that shows.

What changes with a system

• The report is filled in on site from a phone, with the real time and the real technician.
• The dashboard flags what is overdue and what comes due in 7 and 30 days.
• The record prints complete and current, without assembling it by hand for every audit.
• Manuals and certificates live next to the equipment, not in a shared folder.

One figure from practice

With MedKeep, one of our clients manages more than 3,000 assets and more than 16,000 completed maintenance jobs. The volume is not the interesting part: what matters is that any one of those 16,000 can be traced back to who did it and what they found.