Czy dział techniczny szpitala może samodzielnie wykonać przegląd okresowy instalacji gazów medycznych?

Nie, chyba że jest to użytkownik dopuszczony do tego przez producenta — przegląd okresowy systemu rurociągowego do gazów medycznych wykonuje producent, podmiot autoryzowany albo użytkownik dopuszczony przez producenta. Personel techniczny szpitala może prowadzić bieżącą konserwację, ale wyłącznie w zakresie dopuszczonym przez instrukcję używania; źródłem uprawnienia jest instrukcja producenta, a nie doświadczenie działu ani analogia do innych instalacji. Działania serwisowe i naprawy są zastrzeżone dla producenta lub autoryzowanego serwisu. Dodatkowo dopuszczenie wykonawcy do pracy przy instalacji leży po stronie Osoby Upoważnionej (AP) wskazanej w załączniku G do PN-EN ISO 7396-1:2016.

Dobudowaliśmy punkty poboru na jednym oddziale — czy trzeba powtarzać badania całej instalacji?

Tak — każda modyfikacja systemu rurociągowego wymaga powtórzenia w całości badania na obecność połączeń krzyżowych, zgodnie z PN-EN ISO 7396-1:2016-07, pkt 12.6.3.2.5. Wynik badania dokumentuje się na formularzu D.8. Rozbudowa i modernizacja to czynności dla producenta lub podmiotu przyjmującego odpowiedzialność, a ich skutkiem może być powstanie nowego wyrobu w rozumieniu MDR (rozporządzenia UE 2017/745). Sama czynność również trafia do dokumentacji wyrobu.

Które czynności przy instalacji gazów medycznych musimy wpisywać do dokumentacji wyrobu, a które nie?

Wpisu wymagają zawsze: przegląd okresowy, przegląd gwarancyjny, działanie serwisowe i naprawa (ta dodatkowo z informacją do producenta) oraz modernizacja i rozszerzenie instalacji. Bieżąca kontrola prowadzona przez użytkownika lub personel oddziału wymaga wpisu tylko wtedy, gdy ujawni nieprawidłowości, a bieżąca konserwacja — jeśli tak wynika z instrukcji używania. Podstawą jest art. 63 ustawy z 7 kwietnia 2022 r. o wyrobach medycznych, który nakazuje dokumentować instalacje, naprawy, konserwacje, działania serwisowe, przeglądy, regulacje, kalibracje, sprawdzenia i kontrole bezpieczeństwa wraz z datami, danymi wykonawcy, opisem i wynikami. Sama bieżąca kontrola nie zastępuje przeglądu i nie zamyka pozycji w harmonogramie.

Inspection, maintenance, repair or upgrade — who may perform what and what goes into the documentation

Not every check is a periodic inspection, not every replacement is a repair, and not every extension is ordinary servicing. The name of the activity determines who may perform it, whether it must be entered in the documentation, and whether liability for modifying a medical device arises.

The name of the activity settles three things at once

In hospital practice, everything that happens around a medical gas installation tends to be called by a single word: "servicing". Convenient in conversation and costly in the documentation. For a medical gas pipeline system (SRGM), which is a medical device or a system of medical devices, the classification of an activity simultaneously determines three things:

who is entitled to perform it — the user, trained technical personnel, an authorised service provider or the manufacturer only;
whether a mandatory entry in the documentation arises of the device;
whether the device is being modified, and with it to assuming responsibility for the modified scope.

The legal framework is provided by art. 63 of the Act of 7 April 2022 on Medical Devices. Ust. 1 requires the device to be correctly installed, maintained and used in accordance with its intended purpose, and obliges the user to follow the instructions for use. Ust. 2 prohibits putting into operation and using a device with defects that may pose a risk to patients, users or other persons. Ust. 3 imposes on the healthcare provider the obligation to hold documentation of the installations, repairs, maintenance, servicing activities, inspections, adjustments, calibrations, checks and safety checks carried out — with dates, details of the contractor, description, results and remarks and, where required, also with the qualifications of the persons performing them. Ust. 4 adds documentation specifying dates of the next inspections and checks, while para. 5 requires all of it to be kept for no less than 5 years from the discontinuation of use of the device.

Six types of activities — table of competences and entries

Activity	Who may perform	Entry in the documentation
Routine inspection	user / ward staff	only when irregularities are found
Routine maintenance	staff trained to the extent permitted by the instructions for use	yes, if it follows from the instructions
Periodic inspection	the manufacturer, an authorised entity or a user approved by the manufacturer	yes
Warranty inspection	the manufacturer or an authorised entity	yes
Service action / repair	the manufacturer or an authorised service	yes, with notification to the manufacturer
Modernisation / extension	the manufacturer or the entity assuming responsibility for the modified scope	yes — a new device within the meaning of MDR may be created

Routine checking is not a periodic inspection

This distinction generates the most disputes during inspections. A routine check — looking at the bed-head unit, listening for hissing at the outlet, seeing whether the signalling panel shows an alarm — is a valuable activity and should be part of the ward's daily routine. But is not an inspection.

It does not cover opening the device, measurements, adjustments or any activity requiring tools and the manufacturer's technical documentation. Consequently, it does not satisfy the obligation arising from art. 63 ust. 3 i 4 and does not close the item in the schedule. A hospital whose "inspections" column contains only records from ward rounds formally has no documented inspections.

Routine maintenance has a limit set by the manual

Routine maintenance may be carried out by trained personnel, but only within the scope permitted by the instructions for use. The manufacturer's instructions are the only source of authorisation here — not the technical department's experience, not an analogy with another installation in the building. If the instructions require the activity to be recorded, the entry is mandatory.

A report on the manufacturer's forms, not on an in-house checklist

The periodic inspection is carried out on the basis of the manufacturer's instructions and its inspection forms. The list of inspection activities should come from the manufacturer's documentation and should not be replaced by a generic list drawn up independently by the hospital, the building contractor or an unauthorised service company. A report based on such an „in-house list” does not prove that what the manufacturer deemed necessary to check was in fact checked.

The inspection report contains at least:

scope of the work performed,
results,
comments and recommendations,
date of performance,
contractor details,
date of the next periodic inspection.

The last item is often skipped, yet it is the one that directly implements art. 63(4). A report without a date for the next activity closes a single event but does not create a schedule — and the supervisory authority asks about the schedule.

Typical scope of inspection activities

The scope follows from the documentation of the specific device, but the core is repeatable and includes, among others:

leak testing of the internal gas installation of bed-head units and pendants,
checking the tightness, the gas-specific keying and the technical condition of the terminal units,
routine check of alarm functions,
monitoring of operating parameters and of supply source alarms.

The terminal unit, flexible hose, valve, seal and crimped fitting are wear parts. Their condition is assessed during the periodic inspection — not at the moment of failure.

Repair and modernisation: where servicing ends

Servicing and repair belong to the manufacturer or an authorised service provider, and the documentation entry is supplemented by a notification to the manufacturer. Upgrading and extending the installation go further: they are carried out by the manufacturer or by an entity that assumes responsibility for the modified scope, and the consequence may be the emergence of a new device within the meaning of MDR 2017/745 — of Regulation (EU) 2017/745. This is not an accounting formality: the addressee of responsibility for the conformity of the system changes.

Every modification of the pipeline system also triggers a testing obligation. PN-EN ISO 7396-1:2016-07, clause 12.6.3.2.5, requires repetition in full tests for the presence of cross-connections if any modifications are made to the system; the result is documented on form D.8. This is described in more detail in the entry on cross-connections and gas interchange.

Who authorises the contractor to start work

Classifying an activity is of no use without someone who applies it. Annex G to PN-EN ISO 7396-1:2016 assigns this to the Authorised Person (AP): they issue permits to work on the SRGM, inform the wards of planned interruptions, decide on taking the system out of service and returning it to service, and are responsible for ensuring that the work is carried out only by trained personnel or approved contractors holding a quality management system certificate of the appropriate scope. This role is discussed in the post on the Authorised Person (AP) and Annex G.

It is worth remembering that the scope of activities is also subject to external inspection. Art. 64 ust. 1 pkt 5 of the Act on Medical Devices 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.

Frequently asked questions

Can the hospital's technical department carry out the periodic inspection of the medical gas installation on its own?

No, unless it is a user authorised to do so by the manufacturer — a periodic inspection of a medical gas pipeline system is performed by the manufacturer, an authorised entity or a user authorised by the manufacturer. The hospital's technical staff may carry out routine maintenance, but only within the scope permitted by the instructions for use; the source of the authorisation is the manufacturer's instructions, not the department's experience or an analogy with other installations. Servicing activities and repairs are reserved for the manufacturer or an authorised service provider. In addition, admitting a contractor to work on the installation is the responsibility of the Authorised Person (AP) indicated in Annex G to PN-EN ISO 7396-1:2016.

We have added terminal units on one ward — do the tests of the entire installation have to be repeated?

Yes — every modification of the pipeline system requires the cross-connection test to be repeated in full, in accordance with PN-EN ISO 7396-1:2016-07, pkt 12.6.3.2.5. The test result is documented on form D.8. Extension and upgrading are activities for the manufacturer or for an entity assuming responsibility, and they may result in a new device within the meaning of the MDR (Regulation (EU) 2017/745). The activity itself is also entered into the device documentation.

Which activities on the medical gas installation must we enter in the device documentation and which not?

An entry is always required for: a periodic inspection, a warranty inspection, a servicing activity and a repair (the latter additionally with notification to the manufacturer), as well as an upgrade and an extension of the installation. A routine check carried out by the user or ward staff requires an entry only if it reveals irregularities, and routine maintenance — if the instructions for use so provide. The basis is art. 63 of the Act of 7 April 2022 on Medical Devices, which requires installations, repairs, maintenance, servicing activities, inspections, adjustments, calibrations, checks and safety checks to be documented together with dates, details of the contractor, description and results. A routine check alone does not replace an inspection and does not close the item in the schedule.

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 — clause 12.6.3.2.5, form D.8 (Annex D), Annex G (roles, including the AP)
Gazy Medyczne w Praktyce, Zeszyt 1, 2026 ed., INMED S.A. — types of service activities, staff competences, 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.