Who in the hospital is responsible for the medical gas installation — the Authorised Person (AP) and Annex G
Annex G to PN-EN ISO 7396-1:2016 does not leave the question „who is responsible for this" unanswered — it defines eight roles and places one of them at the centre. The Authorised Person (AP) decides who may work on the installation and when the system returns to service, and the standard recommends consulting them on every purchase of equipment connected to the installation.
The question „who in the hospital is responsible for the medical gas installation" is often treated as rhetorical. In practice it has one specific answer, written down in Annex G to PN-EN ISO 7396-1:2016, and if the hospital cannot name a person, this does not mean that the responsibility is dispersed — it means that it has not been assigned.
Eight roles from Annex G
The standard describes the responsibility structure on the healthcare facility's side as a set of distinct functions. These are not posts within the meaning of the organisational rules — they are roles that someone has to actually perform.
| Designation | Role according to Annex G |
|---|---|
| EM | chief executive officer |
| FEM | facility technical director |
| AP | Authorised Person |
| CP | competent person |
| QC | quality controller |
| DMO | designated medical staff member |
| DNO | a designated nursing staff member |
| DP | designated person |
Separating these roles makes practical sense: one person is responsible for the organisational decision (EM), another for maintaining the facility (FEM), another represents the clinical side (DMO, DNO), and another is responsible for quality (QC). There is, however, only one point where these threads come together.
Authorised Person (AP) — a function, not a title
The AP is the role around which the standard builds supervision of the medical gas pipeline system (SRGM). Annex G sets out several recommendations for it that are worth reading literally.
Appointment in writing
The standard recommends that the AP be appointed in writing by the chief executive officer. This is not formalism for the auditor. A verbal „the technical department handles that" does not create a body that issues permits to work, suspends operation and signs off the decision to restart. The letter of appointment is at the same time the document showing that the hospital has built this mechanism at all.
Technical competence
The AP is to possess the technical knowledge needed to understand the hazards associated with operating the system. This is a functional condition: a person who does not understand why cutting a pipeline in the ceiling of the adjacent room is a critical event cannot assess a permit-to-work application.
Independence from the contractor
The most frequently omitted requirement and at the same time the most important: the AP must be independent of the contractor carrying out work on the installation. Assigning this role to an employee of the company that is currently carrying out the refurbishment of the operating theatre suite destroys the whole point of the arrangement — the contractor would then be signing off on its own work. A root cause analysis published by AHRQ, concerning a terminal unit labelled as oxygen but connected to nitrous oxide, pointed directly, among other things, to unclear division of responsibility for supervising and accepting completed maintenance work. This is exactly the gap the AP is meant to close.
Permits to work and informing the wards
The AP's tasks include issuing permits to work on the SRGM and informing the wards of planned interruptions of supply. The importance of this mechanism is shown by the case from Japan of 23–24 December 1987: two deaths in adjacent operating theatres after the oxygen and nitrous oxide pipelines had been swapped. The hospital was rebuilding the adjacent theatre, the installation of new ventilation ducts in the ceiling forced the medical gas pipelines to be cut, the pipes were neither labelled nor colour-coded, and after the works were completed no tests were carried out at the terminal units of the operational theatre next door — and the anaesthesiology department was not informed of the works. The case became the direct impetus for the introduction of Japanese standards for medical gas installations.
The AP is also responsible for labelling terminal units that are faulty or require supervision, and for ensuring that work is carried out only by trained staff or approved contractors holding a quality management system certificate of the appropriate scope. The question of who may perform which activity at all, is therefore settled before work starts, not after the fact.
Shutdown and return to service
This is the strongest power of the AP: the decision to shut the system down and the decision to return it to service. The practical question is always the same — on what basis the AP signs the approval for a theatre to go back into use. The standard answers in pkt 12.6.3: it must be proven that no cross-connections exist between pipelines of different gases or vacuum, by testing all terminal units with only one system filled with gas at a time. Point 12.6.3.2.5 requires repeat the test in full if any modifications are made to the pipeline system. The result is documented on form D.8. Without this report the AP's decision to put the system back into service has nothing to rest on — this is described in more detail in the entry on cross-connections and gas interchange.
Consulting every purchase
Annex G recommends consulting the AP every purchase of a medical device that will be connected to the installation — so that the system's design specification continues to be met. This requirement translates directly into the work of the public procurement department. An installation designed for specific parameters is not an infinite resource; successive devices add up to a load that no one has recalculated. In October 2021 Szpital Południowy in Warsaw faced insufficient capacity of the vaporisers under a load many times exceeding the installation's original design assumptions — crisis intervention by the voivode, delivery of a tank from strategic reserves and construction of an additional oxygen line were required.
Why this is not an internal procedure but a legal obligation
A medical gas installation is a medical device or a system of medical devices — it is subject to Regulation (EU) 2017/745 (MDR) and to the Act of 7 April 2022 on Medical Devices. Art. 63 ust. 1 requires the device to be correctly installed, maintained and used in accordance with its intended purpose, ust. 2 prohibits putting into operation and using a device with defects that may pose a risk to patients, users or other persons, and ust. 3 i 4 impose the obligation to keep documentation of the installations, repairs, maintenance, inspections and safety checks carried out, together with the dates of the next activities. The documentation is retained for not less than 5 years from the date the device ceases to be used (ust. 5). The President of URPL is moreover empowered to inspect the entities performing those activities at the place where they are performed (art. 64 ust. 1 pkt 5).
The AP's decision to shut down the installation is therefore the operationalisation of the prohibition under art. 63(2), and the documentation of their actions — evidentiary material.
Illustration of the risk mechanism
In December 2025 an incident occurred in one of Warsaw's hospitals, after which, on 9 January 2026, the Mayor of the City of Warsaw ordered an inspection of medical gas installations and delivery equipment in all municipal hospitals, and the Patient Ombudsman opened an ex officio investigation. The proceedings are being conducted by the prosecutor's office, experts have been appointed, and the actual course of the event and its causes have not been established in a binding manner. No one should prejudge liability before the proceedings are concluded. We cite this case solely as the reason why the question of the AP has returned to the agenda of hospital management.
The common denominator of documented cases from decades ago — Melbourne 1983, Japan 1987, the AHRQ analysis — is, by contrast, known and unchanging: work on the installation after which the tests were not repeated. The AHRQ analysis additionally pointed to an unclear allocation of responsibility for supervising and accepting completed maintenance work.
Three verification questions
- Does the hospital have an AP appointed in writing for the medical gas installation — and is it independent of the contractor performing the work?
- Is it functioning permit-to-work system on the pipeline system, and are the operating theatre suite and the wards informed of the works?
- Is the purchase of every new device connected to the installation consulted with the AP in terms of the impact on the system?
If the answer to any of them is "I don't know", that is not a gap in the documentation. It is a gap in the chain of responsibility that the standard described precisely so that a court-appointed expert would not have to reconstruct it later.
Frequently asked questions
Can works on medical gas pipelines be performed by any installation company selected in a tender?
No — work on a medical gas pipeline system (SRGM) is to be carried out only by trained personnel or by approved contractors holding a quality management system certificate of the appropriate scope. The Authorised Person (AP), appointed in writing by the chief executive, is responsible for ensuring this and for issuing the permit to work. The AP is also to be independent of the contractor carrying out the work — assigning this role to an employee of the company refurbishing the installation would mean that the contractor signs off on its own work.
After which works must the installation tests be repeated and in which document is the result recorded?
The test is repeated in full after any modifications to the pipeline system — this is required by point 12.6.3.2.5 of PN-EN ISO 7396-1:2016. In accordance with point 12.6.3, it must be proven that no cross-connections exist between pipelines of different gases or vacuum, by testing all terminal units with only one system filled with gas at a time. The result is documented on form D.8, and the decision to return the installation to service is taken by the Authorised Person (AP).
How long must a hospital retain the documentation of the installation, repairs and inspections of the medical gas installation?
Not less than 5 years from the date the device ceases to be used. A medical gas installation is a medical device or a system of medical devices, so the Act of 7 April 2022 on Medical Devices (art. 63 ust. 3 i 4) imposes an obligation to keep documentation of the installations, repairs, maintenance, inspections and safety checks carried out, together with the dates of the next activities. The President of URPL has the power to inspect the entities performing those activities at the place where they are performed.
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 — Annex G (roles EM, FEM, AP, CP, QC, DMO, DNO, DP), clauses 12.6.3 and 12.6.3.2.5, form D.8
- Medical Gases in Practice, Volume 1, 2026 edition, INMED S.A.
- Source materials for the events cited: Anesthesia Patient Safety Foundation (APSF), Fatal Pipeline Accidents Spur Japanese Standards; M. Pauling, C. M. Ball, Delivery of Anoxic Gas Mixtures in Anaesthesia, 2017; AHRQ WebM&M, Hypoxic Gas Supply from Cross-Connected Pipelines
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.