Technology & Services

Medical Gas Pipelines Utility or Life Suppor t?

a report by

Jan Strybol
European Technical & Regulatory Affairs Manager for Air Products Medical explains the new CEN & ISO standard on medical gas pipeline systems (MGPS)

Since 1998, healthcare facilities and companies supplying medical gas and equipment in Europe have gained extensive experience of medical gas pipeline systems built to EN 737-31. In 2002 the equivalent ISO 7396-12 was published and in the same year the NFPA 99C3 was revised in the US. Since then, however, increased interest in pipeline systems has led to new standards that we must all understand and comply with. One of the influencing factors has been that an increasing number of pharmaceutical authorities in Europe have started to demand Marketing Authorisations for medical gases in line with Directive 2001/83/EC4. In 1998 the European Directive on Medical Devices 93/42/EEC also came into force and many countries now consider MGPS as medical devices. Furthermore, since EN 737-3 is a harmonised standard, there is presumption of compliance to the essential requirements of the Medical Device Directive when adhering to this standard. As a result of these changes, there is now an increased focus on standards within medical pipeline distribution networks. In response standardisation bodies CEN and ISO agreed to work together, under CENs lead, to write one document replacing both previous standards. The following is a description of the key requirements of this new standard, which was published for public enquiry in August 2004. Also included are details of the specific responsibilities now placed on healthcare facilities to continually improve the safety around MGPS for patients and operators.
Guarantee of Supply and Correct Product Supply

hospital or special care centre. Medical gases, such as oxygen, nitrous oxide and air as well as vacuum are used nearly everywhere in healthcare facilities. So much so that the number of terminal units in a 1,000bed hospital can run up to 4,000, fed by tens of kilometres of piping. This complex and extensive system eventually leads to a doctor and patient who expect, or rather depend upon, the right gas at the right pressure and flowrate and expect it to be available 100% of the time. Thanks to a long history of reliability of MGPS in hospitals, healthcare workers and patients have enjoyed peace of mind. The fact is most hospitals have never experienced a problem. Consider what would happen in your facility if that reliability was no longer guaranteed. The questions that need to be answered include issues of what if the MGPS failed, what if the gas to all terminal units stopped and what if the gas was the wrong product. Just because it is yet to happen at your facility, do not be lulled into a false sense of security it has actually happened at others. The reliability of the MGPS is dependent on the correct application of standards and procedures hence the new ISO standard. To ensure the continuity of supply to patients, CEN and ISO have defined the principle of single fault condition a condition that states that the system must continue to provide uninterrupted supply given any single equipment failure or abnormal circumstance. Just because it is yet to happen at your facility, do not be lulled into a false sense of security it has actually happened at others. In the real world, normal operation includes maintenance of an MGPS, so one source such as a bulk liquid oxygen tank being offline for maintenance is not considered abnormal operation. This means that a MGPS must have three sources of supply, for instance two bulk liquid oxygen tanks, plus one cylinder back-

The MGPS for medical gases and vacuum is a critical part of the medical installation and the service in a
1. 2. 3. 4.

EN 737-3: 1998 Medical Gas Pipeline Systems Part 3: Pipelines for compressed medical gases and vacuum. ISO 7396-1:2002 Medical Gas Pipeline Systems Part 1: Pipelines for compressed medical gases and vacuum. NFPA 99 C: 2002 Gas and Vacuum Systems. Dir. 2001/83/EC: 2001 Directive of the European Parliament and of the Council on the Community code relating to medicinal products for human use.

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Figure 1

line oxygen analyser cylinder back-ups, that all meet the latest standards and pharmacopoeia specification. Having defined this key principle, all other requirements for ensuring continuous supply while equipment is out of service or being maintained follow suit, in other words the need for parallel pressure regulators, by-passes and emergency and maintenance supply connections. This does not necessarily mean increased costs of installation for healthcare facilities. A carefully designed air compressor system with three smaller air compressors, or a vacuum system with six to 10 small vacuum pumps can be more cost-effective in electricity and maintenance costs than one with only two large sources of supply. Even if this approach were more expensive in terms of initial capital outlay it does not take into account the hidden cost of rework, failure, major leaks, or poor maintenance. Systems with suitable redundancy built in at the start are simpler to operate and maintain. Moreover, equipment and labour costs associated with normal operation only are discussed here, because an injury or fatality for a member of staff or a patient, as result of ineffective or wrong supply, cannot be calculated in Euros. Although in most Western countries, companies who install or maintain MGPS systems are very professional and fully understand the risks, there are still many plumbers, even in Europe, who install copper piping for medical oxygen and air to the same standard as the other part of their contract piping for water or waste fluids.
Medical Devices

Figure 2

The majority of European countries have defined, or at least consider, MGPS as Medical Devices (MD) according to the EU Directive 93/42/EEC5. The Belgian medical device authorities have defined MGPS as MDs, based on Article 12, which describes the conditions for a system or procedure pack. The Co-ordination of Notified Bodies Medical Devices (NB-Med) which has published its consensus statement S/06/98 reinforces this. The Italian authorities audit MGPS manufacturers against the Directive and no tenders are granted without CE marking. In contrast, the UK has set up its own Quality Assurance system and standard requirements ISO 9000 and HTM 20226 guidelines to which

up, three cylinder banks, two air compressors with cylinder back-up or three vacuum pumps. Furthermore, any more complex equipment must have automated redundant back-ups, for instance, Air Products medicinal air blending system with dual on-

5. Dir. 93/42/EEC: 1993 Counsel Directive concerning medical devices. 6. HTM 2022:1994 Medical gas pipeline systems.

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Medical gas pipelines utility or life suppor t?

suppliers and installers of a MGPS have to comply prior to being granted a contract. However, since medical gas pipelines deliver medicinal gases for patient use, it is essential that adverse events arising in the delivery of these gases are reported and acted upon within the European regulatory system. This control will only be enforced when MGPS are regulated by the same competent authorities and directives that control other MDs such as anaesthetic and respiratory equipment. A pure quality system or guideline cannot guarantee the user and supplier that this obligation meets materio-vigilance requirements. Other reasons why CE marking of MGPS means a safe and reliable system for patients and operators needs to be considered: the directive is the best formal process, ensuring that the MGPS is installed to the standard; incidents most often occur during and after changes: the management of change is part of the directive requirements; MGPS systems are installed for many years long term compliance to ISO 7396-1 is best achieved and audited against the directive; many specific components of current MGPS are already medical devices, e.g., terminal units, pressure/flow regulators only the copper tubing and a few other components are not yet, but the directive includes these in Article 12; by applying risk assessment during the design and installation phases of a MGPS, components that are not necessarily medical gas pipeline specific, such as medical supply units (such as bed head trunking) are more effectively covered when part of an entire CE marked system; the quality of installation can be measured against one directive and one standard, instead of a set of local specifications; and the commissioning, validation and verification procedures are standardised and are therefore more cost effective and easier to audit. The main advantages of defining MGPS as medical devices are four-fold: one directive replaces the need for a combination of national, industry and healthcare standards; the requirement for a dedicated quality assurance (QA) system ISO 134857 which also includes a traceability system; the availability of an international approved standard EN ISO 7396-1 to audit against, both for authorities and healthcare facilities; and the mandatory reporting of materio-vigilance incidents.
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Figure 3

Figure 4

7. ISO 13485: 2003 Medical Devices Quality management systems Requirements for regulatory purposes.

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Figure 5

there is another new annex entitled Risk Assessment Procedure and Check List; and it states that the manufacturer is required to provide the user of the MGPS with user instructions.
User Requirements

It is no surprise that we see an additional emphasis on the user requirements for medical devices. Until now, these are only summarised in the instructions for use of the equipment or installation. EUROM VI8 recently proposed to the European Commission in its standard Use of Medical Devices Improving Safety and Performance of March 2004, the introduction of responsibilities for the user in the European Directive 93/42/EEC. The prEN ISO 7396-1 reads: The manufacturer of the complete system or the manufacturers of each component of the medical gas pipeline system (i.e. supply systems, monitoring and alarm system and pipeline distribution system) shall provide the healthcare facility with instructions for use. The manufacturer(s) of each component of the medical gas pipeline shall provide operational management information to the healthcare facility to enable it to draft its Operational Management Document. The system manufacturer(s) shall provide instructions to the healthcare facility for recommended maintenance tasks and their frequency and a list of recommended spare parts.
Risk and Operational Management

prENISO7396-1: Pipelines for Compressed Medical Gases and Vacuum

prENISO7396-1 also features, including:

has

some

major

new

three sources of supply are required for the continuity of supply; one or more reserve source(s) can be installed anywhere on the pipeline distribution network, enhancing safety for the patient; both supplier, installer and user are required to apply risk management principles for capacity and location of the sources of supply and the number of full cylinders held in storage; extensions of a MGPS are more clearly described; for double-stage systems (i.e. where pressure is regulated in two steps) duplex press regulators are required for all applications; the section on testing requirements has been made more practical; the typical drawings are simplified to allow a maximum flexibility for manufacturers in meeting each customers needs; there is new annex specifying operational management requirements, which incorporates some previous annexes such as emergency guidelines;
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Probably the most important changes for the healthcare facility in the prEN ISO 7396-1 are annexes F and G, giving recommendations for healthcare managers and their staff on the risk management and operational management requirements of MGPS systems.
Risk Management

Each healthcare facility has its own specific layout for its MGPS. Moreover, the capacity of the sources of supply should be calculated for the specific needs of the healthcare facility the different requirements for medical gases and vacuum require a local study to ensure continuation of supply of the correct product.

8. EUROM VI: European Federation of Precision Mechanical and Optical Industries. Group VI - Medical Technology.

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Medical gas pipelines utility or life suppor t?

Figure 6

Annex F in the draft standard gives a list of the most important potential risks that need to be assessed and managed. The procedure for managing risk is to eliminate it as far as possible by design, in other words, to make the system inherently safe. If this is not entirely possible, then the next step is to define procedures and training to control the remaining risks to an acceptable level. By assigning risk levels, the frequency of occurrence and the severity of the risk, one can rank the risks and deal with them in the appropriate manner. As a supplier Air Products is frequently called upon to assess and manage these risks to the highest safety level practically possible. Annex F gives a list of typical critical items that may impact on the safety of the MGPS and the quality of the gases delivered. The typical risk assessment checklist provided should be used by both the manufacturer of the MGPS and the healthcare facility during design, installation, commissioning and operation and on-going operation and monitoring of the MGPS.
Operational Management

facilitys buildings, requiring input from many different people, can only be safely managed when all aspects of operational management are described in detail in an Operational Management Document. Furthermore they should be led and supported by the senior management of the facility. Annex G represents best operating management practice for the operation of the MGPS. The primary objective of this annex is to assign responsibilities to ensure the provision of safe and reliable MGPS and its efficient operation and use and maintain patient safety through continuity of supply. This objective will only be achieved if the medical and nursing users and estates staff participate in the introduction of an operational policy designed to minimise the hazards likely to arise from misuse of the system. This annex also looks at issues of operational management including statutory requirements, functional responsibilities, operational procedures, training and communications, cylinder and sources of supply management, preventative maintenance and repair and risk assessment, giving definitions and working practices throughout. It is intended for use by operational managers, engineers, quality controllers, technicians, finance officers and other professionals involved in the dayto-day running of a MGPS. One of the objectives of this annex is to clarify the requirements of the operational management system for healthcare staff and any contractors involved, prior to its initial use or after any modifications.

When the MGPS is in use, the system needs to be continuously maintained and repaired. Very often in healthcare facilities the MGPS system is continuously modified, extended or simply upgraded for the growing number of patients or new applications of medical gases and vacuum. These types of changes on such a large system as the MGPS, which runs throughout the healthcare

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The operation of existing installations should also be assessed for compliance with the standard and this annex. A plan for upgrading existing systems should be prepared on the basis of risk management, ensuring that patient safety is maintained throughout the process. Managers will need to liaise with medical colleagues and take account of other published guidance in order to assess the system for technical shortcomings. Annex G also identifies the distinct functions that need to be exercised and the responsibilities that go with them. These describe the individuals role in connection with the MGPS, but are not intended to be prescriptive job titles. Indeed, some of the personnel referred to may not be resident staff, but people employed by outside bodies and working on contract. The key personnel with specific responsibilities for the MGPS within the operational policy are: executive manager; facilities engineering manager; authorised person; competent person; quality controller; designated medical officer; designated nursing officer; and designated person.

The document should state the procedures to be followed and the personnel who need to be consulted before a new item of medical equipment is connected to the MGPS. Special attention should be paid to the change of supply system or the introduction of an oxygen concentrator system for supplying oxygen to the MGPS.
The Way Forward

Now that there are directives that follow a new approach, in other words they do not give a detailed list of specific requirements, but lay down broad basic principles and refer to standards for the detailed specifications, the exact compliance to these standards to satisfy authorities, notified bodies and customers needs to be even more focused upon. The CE marking of medical devices has dramatically reduced the barriers that some approval organisations and even local authorities have put in place to increase or safeguard their influence. For instance in the past they have done this by preventing equipment or services being launched without their own tests and approval or adding additional rules that override all others. Organisations such as CEN, the European Committee for Electrotechnical Standardization (CENELEC), ISO and the International Electrotechnical Commission (IEC) now cooperate more often and more closely. Other similar major players, like the American Society for Testing and Materials (ASTM) and NFPA, still remain at the side of evolution towards globalisation of standards. Authorities too, are communicating more with each other and are forming true international working groups, with the aim of defining the safest possible practices for their communities. Borders and barriers are, if not removed, then at least defined as more flexible and less restraining. Sandwiched between all these stakeholders who are jostling for position we find the companies, and of course the consumers, each forming closer federations, to protect their interests. Nevertheless, this overall movement towards globalisation, ever-increasing control, more stringent requirements and higher investment in resources, can only result in continuous innovation, better services, and ultimately, safer products.

In all cases however, it is essential to identify an authorised person who is responsible for the day-today management of the MGPS. This person should ensure that the MGPS is operated safely and efficiently and decide whether an MGPS should be put into or taken out of service.
Operational Management Document

The operational management requirements for operating the MGPS should be detailed in an operational management document. It should include the following documented procedures for:
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control of documents and records; training and communication; emergency; change of management; permit-to-work; preventative maintenance; repair; sources of supply management; cylinder storage and handling; medical equipment purchase; and managing contractors.

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