Ten check questions about the medical gas installation — and what accreditation says about it
Ten questions that can be asked without an auditor and without a service visit — a binder of documentation and one hour of the technical department's time is enough. Each of them is grounded in the Medical Devices Act or in the standard PN-EN ISO 7396-1, and the accreditation assessor will ask for the answers later as well.
The list below requires no auditor, no contractor and no service order. All you need is the technical documentation, the inspection schedule and one hour of the technical department's time. If the answer to even one question is „I don't know”, that is precisely the moment for an inspection.
Ten questions worth asking on Monday morning
- Does the hospital have an Authorised Person (AP) appointed in writing for the medical gas installation — and is it independent of the contractor performing the work?
- Is there inspection schedule with a defined due date for the next activity for each item?
- Do the inspection reports come from manufacturer's forms, or from a list compiled in-house?
- Whether after every construction, renovation or installation work in the area of the pipelines, was there carried out a full test for the presence of cross-connections?
- Were the newly commissioned operating theatres, pendants and panels subjected to testing before the first patient — with documented gas identification at every terminal unit?
- Is it functioning permit-to-work system on the medical gas pipeline system (SRGM), and are the operating theatre suite and the wards informed about the work?
- Was it checked the actual capacity of the supply sources — the main tank, the reserve tank and the emergency cylinder source — against current rather than design demand?
- Are the alarm and signalling systems periodically tested, and the results documented?
- Is the purchase of every new device connected to the installation consulted with the AP in terms of the impact on the system?
- Is the inspection documentation retained for the required 5 years and ready to be presented to the inspection authorities?
Where these questions come from
None of them is an auditor's invention. A medical gas installation is a medical device or a system of medical devices — it falls under Regulation (EU) 2017/745 (MDR) and the Medical Devices Act — and not a building service alongside water and ventilation. Hence the sources of the individual questions:
- Questions 2, 3 and 10 — art. 63 of the Act of 7 April 2022 on medical devices. Ust. 3 imposes an obligation to hold documentation of installation, repairs, servicing, inspections and safety checks, containing at minimum the dates, the contractor's details, a description, the results and remarks. Ust. 4 requires documentation specifying dates of the next of inspections and checks. Paragraph 5 — retention for no less than 5 years from the discontinuation of use of the device.
- Questions 4 and 5 — clause 12.6.3 of PN-EN ISO 7396-1:2016-07 requires proof that no cross-connections exist between pipelines of different gases or vacuum; the test is carried out in all terminal units, with only one system filled with gas at a time, and the result is recorded on form D.8. Clause 12.6.3.2.5 requires the test to be repeated in full, if any modifications have been made to the pipeline system. Not a portion — the whole. In more detail: cross-connections and gas interchange.
- Questions 1, 6 and 9 — Annex G to PN-EN ISO 7396-1:2016. The standard recommends that the AP be appointed in writing by the chief executive, possess the technical knowledge needed to understand the hazards and be independent of the contractor carrying out the work. Their tasks include issuing permits to work on the SRGM, informing the wards of planned interruptions and deciding on taking the system out of service and returning it to service. The standard also recommends consulting the AP on every purchase of equipment that will be connected to the installation. More on this: the role of the Authorised Person.
- Questions 7 and 8 — Annex F, risk analysis table: failure of a critical component, failure of the maintenance system, incorrect specification of supply sources, changes in oxygen demand arising over time. As risk control measures the standard indicates routine inspections of supply sources and alarm systems and the checking of alarms for their ability to detect failures of critical components. Responsibility for most of them is assigned to the healthcare organisation — not to the manufacturer.
The accreditation surveyor asks the same questions
Medical gas documentation works towards accreditation points. The answers from the list above feed directly into the material verified during an accreditation review:
| Standard | What it concerns | Questions from the list |
|---|---|---|
| JZ12 | emergency backup supply of power, water and medical gases | 7, 8 |
| JZ13 | scheduled inspections and maintenance of medical equipment — the pipeline system (SRGM) and its components should be included in maintenance schedules, technical passports or the equipment records system | 2, 3, 10 |
| JZ14, JZ7.1 | staff training | 6 |
| JZ8 | technical condition of the infrastructure | 4, 5 |
| FA6 | supervision of the storage of medicinal products and medical devices | 7, 9 |
| CO2 | procedures for special situations | 6, 8 |
| group BP1 | adverse events: gas failure, incorrect connection, loss of oxygen, contamination of medical compressed air, faulty alarm | 4, 5, 8 |
Three recipients of the same documentation
A register of supply sources, a schedule of checks, an emergency procedure, test reports, training records and gas quality test results are not merely technical documentation. They are evidence — and they have three different recipients:
- Accreditation surveyor — checks the existence, completeness and currency of the records against the standards listed in the table.
- URPL inspection — art. 64 ust. 1 pkt 5 of the Medical Devices Act empowers the President of URPL to inspect entities performing activities related to the installation, servicing, upkeep, maintenance, inspection, repair or periodic safety checking of devices — at the place where these activities are carried out. The absence of a schedule and of reports is not an operational oversight; it is non-compliance with the Act.
- Court expert witness — in a worst-case scenario the documentation is the only record of what was checked and when.
This third recipient turns up without warning. In December 2025, at one of Warsaw's hospitals, an incident occurred which is now the subject of a prosecutor's investigation with court experts appointed; the actual course of events and its causes have not been established in a binding manner and no one should prejudge liability before the proceedings are concluded. Whatever their outcome, the system's response was immediate: on 9 January 2026 the Mayor of the Capital City of Warsaw ordered inspections of installations and equipment delivering medical gases in all municipal hospitals, and the Patient Ombudsman opened an ex officio investigation. In an inspection of this kind, arrears cannot be made up — what is shown is what is in the binder on the day of the visit.
A fraction of a per mille
The cost of a periodic inspection of a medical gas installation is a fraction of a per mille of the hospital's budget. The cost of its absence can be irreversible. That is the only calculation to be made here — and this is why a periodic inspection is a clinical decision, not a line in the maintenance budget.
Frequently asked questions
After rebuilding part of the installation, is it enough to test cross-connections only on the modified section?
No — after any modification of the pipeline system the cross-connection test must be repeated in full, not only on the rebuilt section. This is required by pkt 12.6.3.2.5 of PN-EN ISO 7396-1:2016-07. The test itself is carried out at all terminal units, with only one system filled with gas at a time, and the result is documented on form D.8. The obligation applies to all construction, refurbishment and installation work in the area of the pipelines.
Can the Authorised Person (AP) be an employee of the company carrying out works on our installation?
No, they should not — Annex G to PN-EN ISO 7396-1:2016 recommends that the Authorised Person be independent of the contractor carrying out the work. The AP is appointed in writing by the chief executive and must possess the technical knowledge needed to understand the hazards. Their tasks include issuing permits to work on the medical gas pipeline system (SRGM), informing the wards of planned interruptions and deciding on taking the system out of service and returning it to service. The standard also recommends consulting the AP on every purchase of equipment that will be connected to the installation.
How long must inspection reports for medical gas installations be retained and what must they contain?
Not less than 5 years from the date the device ceases to be used — so provides art. 63 ust. 5 of the Act of 7 April 2022 on Medical Devices. Documentation of installations, repairs, maintenance, inspections and safety checks must contain at least dates, details of the contractor, description, results and remarks (ust. 3), and separately also the dates of the next inspections and checks (ust. 4). Art. 64 ust. 1 pkt 5 empowers the President of URPL to inspect those activities at the place where they are performed, so the absence of a schedule and of reports is not an economic oversight but non-compliance with the Act.
Basis
- Regulation (EU) 2017/745 (MDR).
- Act of 7 April 2022 on Medical Devices — Art. 63(3), (4) and (5); Art. 64(1)(5).
- PN-EN ISO 7396-1:2016-07 — clause 12.6.3, clause 12.6.3.2.5, Annex D (form D.8), Annex F (risk analysis table), Annex G (roles, including the Authorised Person / AP).
- Accreditation standards: JZ12, JZ13, JZ14, JZ7.1, JZ8, FA6, CO2, group BP1.
- Medical Gases in Practice, Booklet 1, 2026 edition, INMED S.A.
The topic is developed in the guide „Medical gases in practice. Volume 1" (GMWP) developed by INMED S.A. — the legal qualification of the installation, staff competences, types of service activities, tests and acceptances, and the Operational Management Documentation together with template procedures and forms. Order the GMWP guide.