Inspections of medical gas installations are a statutory obligation, not a line in the maintenance budget
2026-01-19 · Medpipe technical team
In brief. A medical gas pipeline system is a medical device within the meaning of Regulation MDR (EU) 2017/745. The obligation to keep documentation of the installation, repairs, maintenance, inspections and safety checks is imposed by Art. 63 of the Act of 7 April 2022 on medical devices. The documentation is retained for at least 5 years after the device is no longer used. The scope and frequency of inspections follow from the manufacturer's documentation and from the standard PN-EN ISO 7396-1:2016-07. Compliance with these obligations is inspected by the President of the URPL on the basis of Art. 64(1)(5).
A medical gas pipeline system is a medical device, not a building service — and this determines everything that subsequently happens with its documentation. The absence of an inspection schedule is not a saving on maintenance, but non-compliance with the Medical Devices Act.
Is a medical gas installation a medical device?
The most common organisational mistake is to put the medical gas pipeline system (SRGM) on the same list as water, sewage and ventilation — that is, to classify it as a building service. The consequences of this error remain purely formal only until the first inspection or the first adverse event.
A medical gas installation is a medical device or a system of medical devices. It is subject to:
- Regulation (EU) 2017/745 (MDR),
- the Act of 7 April 2022 on medical devices,
- the standards PN-EN ISO 7396-1:2016-07 and PN-EN ISO 7396-2:2011,
- the manufacturer's documentation.
The mere fact that a pipe runs inside a wall does not make it a building services installation. Function is decisive: a sanitary installation makes the building usable, whereas the SRGM delivers a medicinal product directly to the patient. It is the only system in a hospital that administers a drug without human involvement — without a nurse checking the label, without a pharmacist verifying the batch, without a second pair of eyes at the bedside. Between the supply source and the mask there is only a pipe, a valve, a terminal unit and the assumption that someone once checked it.
What does Art. 63 of the Medical Devices Act require?
Article 63 of the Act on Medical Devices applies to a medical device. The paragraphs are not alternatives to choose from; they form a single closed obligation.
| Provision | What constitutes | What this means for the pipeline system |
|---|---|---|
| Art. 63(1) | The device shall be properly installed, maintained and used in accordance with its intended purpose; the user is obliged to comply with the instructions for use | The scope and frequency of activities follow from the manufacturer's documentation, not from the technical department's discretion |
| Art. 63(2) | It is prohibited to put into service and use a device having defects that may create a risk to patients, users or other persons | A terminal unit that raises doubt is taken out of service, not “observed for the time being” |
| Art. 63(3) | The obligation to hold documentation of the installations carried out, repairs, maintenance, service activities, inspections, adjustments, calibrations, checks and safety controls | The entire life cycle of the installation is documented, not just the acceptance |
| Art. 63(4) | The obligation to hold documentation specifying the dates of the next inspections and checks | The schedule is part of the required documentation |
| Art. 63(5) | The documentation is retained for no less than 5 years from the date the device is withdrawn from use | The period runs from the end of use, not from the date of the report |
Para. 3: the documentation has a defined minimum content
The Act does not stop at the requirement to "hold documentation". It specifies what it must contain as a minimum: dates, details of the contractor, description, results and remarks and, where required, the qualifications of the persons performing the activities. A report without results or without identification of the contractor does not meet this requirement, even if the activity itself was performed diligently. This is also why the name of an activity has legal significance: whether it was a routine check, a periodic inspection, a repair or an upgrade determines who was allowed to perform it and what goes into the documentation (cf. inspection, maintenance, repair or modernisation).
Para. 4: the date of the next inspection is a requirement, not good practice
This is the paragraph most often overlooked in hospital practice. The documentation is to specify the dates of the next inspections and checks — for every component of the device, not collectively for "the installation". A report that describes the past but does not set out the future is incomplete within the meaning of the Act. That is why a properly drawn-up periodic inspection report contains not only the scope of activities, results, remarks, recommendations, date and details of the contractor, but also the date of the next inspection.
Para. 5: five years from cessation of use
The retention period does not run from the date the activity was performed. It runs from the moment the device ceases to be used. For an installation operated for a dozen or more years, this means an obligation to maintain a complete, continuous set of reports throughout that entire time and for a further five years after the system is withdrawn from service. A gap in that set is permanent — it cannot be reconstructed after the fact.
Who inspects the documentation of medical gas installations?
Art. 64 ust. 1 pkt 5 of the Act empowers the President of URPL to inspect entities performing activities related to the installation, maintenance, upkeep, servicing, inspection, repair or periodic safety checking of devices — at the place where those activities are performed. The inspection is therefore not conducted by correspondence and is not limited to the manufacturer. It concerns the place where work on the installation is actually carried out, and its natural subject is the documentation under art. 63 ust. 3 i 4.
The conclusion from comparing the two provisions is unambiguous: the absence of an inspection schedule and inspection reports is not an economic oversight that can be accounted for in terms of savings. It is non-compliance with the Act — one that can be established regardless of whether the installation happens to be working correctly at the time.
Why this is not a line item in the maintenance budget
A budget line can be negotiated, deferred to the following year and prioritised against other expenditure. A statutory obligation is subject to none of these operations. A periodic inspection of a medical gas installation does not compete for funds with a roof refurbishment — it competes solely with the decision not to perform an activity required by law.
A register of supply sources, an inspection schedule, test reports and training records are not merely technical documentation. They are evidence: for a URPL inspection, for accreditation surveyors and — in the worst case — for a court-appointed expert. The cost of a periodic inspection amounts to a fraction of a per mille of a hospital's budget. The cost of its absence can be irreversible.
An illustration of the mechanism, not a determination of the cause
In December 2025, at one of Warsaw's hospitals, an incident occurred that placed this problem at the centre of public debate. A patient in the 14th week of pregnancy came in for a planned, minor gynaecological procedure; during anaesthesia she was given an oxygen mask, her condition deteriorated rapidly, and after more than ten days of hospitalisation at another facility the patient died. According to unofficial media reports, the cause was said to be an incorrect connection of medical gases in the anaesthesia pendant following a recently completed refurbishment. It must be emphasised in the strongest terms: the prosecutor's office is conducting the investigation, court experts have been appointed, and the actual course of events and its causes have not been established in a binding manner. No one should prejudge liability before the proceedings are concluded.
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. Regardless of the findings in this particular case, an inspection comes after the event — and asks for documents that had to be created earlier. If there is any doubt whether they were created, it is worth starting with ten check questions about the medical gas installation.
Frequently asked questions
Who determines the scope and frequency of medical gas installation inspections — the hospital's technical department?
The scope and frequency of activities follow from the manufacturer's documentation, not from the discretion of the technical department. A medical gas pipeline system is a medical device or a system of medical devices, so art. 63 ust. 1 of the Act of 7 April 2022 on Medical Devices applies to it: the device must be correctly installed, maintained and used in accordance with its intended purpose, and the user is obliged to follow the instructions for use. The installation is moreover subject to Regulation (EU) 2017/745 (MDR) and to the standards PN-EN ISO 7396-1:2016-07 and PN-EN ISO 7396-2:2011.
A terminal unit raises doubts, but the installation as a whole works — may we keep using it until the next scheduled periodic inspection?
No — a terminal unit that raises doubts is taken out of service, not "kept under observation until" the next inspection. Art. 63 ust. 2 of the Act on Medical Devices prohibits putting into operation and using a device with defects that may pose a risk to patients, users or other persons. A medical gas installation is the only system in a hospital that administers a drug without human involvement: between the supply source and the mask there is only a pipe, a valve and a terminal unit, with no nurse checking the label and no second pair of eyes at the bedside.
The medical gas installation works without any faults — can an inspection still find non-compliance?
Yes — the absence of a schedule and of inspection reports is non-compliance with the Act on Medical Devices, which can be established regardless of whether the installation happens to be working correctly at the time. Art. 64 ust. 1 pkt 5 of the Act empowers the President of URPL to inspect entities performing activities related to the installation, maintenance, upkeep, servicing, inspection, repair or periodic safety checking of devices — at the place where those activities are performed. The inspection is not conducted by correspondence, is not limited to the manufacturer, and its natural subject is the documentation under art. 63 ust. 3 i 4. The register of supply sources, the inspection schedule, the test reports and the training records also constitute evidence for accreditation surveyors.
Basis
- Regulation (EU) 2017/745 (MDR)
- Act of 7 April 2022 on Medical Devices — Art. 63(1)–(5), Art. 64(1)(5)
- PN-EN ISO 7396-1:2016-07
- PN-EN ISO 7396-2:2011
- Medical Gases in Practice, Booklet 1, 2026 ed., INMED S.A. — legal classification of the installation, types of service activities, Operational Management Documentation
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.
The scope of the audits and inspections we carry out is described here: audits of medical gas installations.
Prepared by: the technical team of Małgorzata Dopierała, Damian Czyczyro and Przemysław Kostera — Medpipe Sp. z o.o., design, audits and inspections of medical gas installations. This article is based on the guide „Gazy medyczne w praktyce. Zeszyt 1” (Medical Gases in Practice, GMWP), INMED S.A.