Standards

To ensure suitability for a given task, any device must be manufactured according to verified standards.

Health-care professionals are by no means the first group to recognize and demand the need for consistent, universal standards in the equipment and materials they work with; in other industries this process dates back many years. An essential requirement for mass distribution of goods is certifiable manufacturing specifications. Industrial standards grew less from a need for safety and more for reasons of commerce, but the potential to advance safe manufacture and use of equipment was soon exploited. During the early industrial revolution, widely used items were custom-built by many manufacturers. The chaos this caused, when trying to put different components together, led to the birth of the standard setting body. The first of these, the British Standards Institute (BSI), began work in 1901 specifying dimensions of rails and steel plate, and now encompasses a wide range of standards from heavy engineering to good employment practice. Attempts at international standardization commenced soon after in the electrotechnical field and culminated ultimately in the establishment of a new body: the International Organization for Standardization based in Geneva, which started work in 1947 (in the spirit of standardization, the abbreviation ISO is retained across all languages). The ISO will be familiar to many anaesthetists as the body that resolved the seemingly random sizes of breathing system connectors (Fig. 28.2) into the universal system we have today (Fig. 28.3).

Figure 28.2 A selection of connectors from older breathing systems showing the lack of uniform dimensions. (Compare with Fig. 28.3.)

Figure 28.3 Modern ‘ISO’ connectors. A. Tracheal tube connector with 15 mm/22 mm diameter fittings. B. Gas scavenging connector with 30 mm diameter fitting.

These organizations produce the standards, but do not enforce them: in the majority of cases the application of standards is voluntary. Organizations can, however, provide independent inspection of products covered by a standard: a process termed conformity assessment. In the UK, BSI also has a conformity assessment function as well as being a standards body. Where BSI carries out such an assessment and a product meets the appropriate standards, the manufacturer may be entitled to affix the familiar BSI Kitemark to its product as a sign of manufacturing conformity (Fig. 28.4).

Figure 28.4 British conformity assessment: a reproduction of the BSI Kitemark taken from a drain cover.

The ISO has also published generic standards for quality management systems. This is the ISO 9000 family of standards (ISO 9001, ISO 9002, ISO 9003). Manufacturers and many other organizations and businesses may choose, as a marker of quality, to be certified by an independent organization as meeting the requirements of the appropriate ISO 9000 standard. This should not be confused with conformity assessment of the finished product.

CE marking

As the EU expands and integrates, there is a need for harmonized conformity assessment of the many goods passing across the borders of member states. Items deemed to require this are described in a number of directives; all medical devices are encompassed within three directives. Within each directive, essential requirements specify the standards for each item. A manufacturer confirms compliance with the essential requirements of a directive by placing the CE (Conformité Européene) mark on their product, once they have followed and complied with an appropriate conformity assessment route (Fig. 28.5). There are certain exceptions from CE marking for ‘custom made’ and investigational devices. Apart from these exceptions, any item specified within a directive cannot be sold within the EU without a CE mark. Regardless of which member state authorizes the manufacturer to place the mark, the item can be marketed in all member states, thus marking achieves both product regulation and compliance with the EC single market. It is inherent in the regulations that products imported from outside the EU are subject to the same set of rules.

Figure 28.5 CE marks on two items of anaesthetic equipment; the lower mark also has a number with it to identify the notifying body employed for part of the conformity process.

Competent authorities and notified bodies

CE marking is of great importance to the health-care sector. Following the incorporation of the Medical Devices Directives, it is now a legal requirement for all medical devices purchased for use in the UK to have a CE mark. A major role for the MHRA is to oversee this process; it is, therefore, termed the Competent Authority for the UK, with other European countries having similar organizations. Exchange of information between Competent Authorities ensures a common approach throughout Europe. Hence, in essence, the MHRA is the UK arm of a large pan-European organization responsible for regulating medical devices. The directives and the standards within are produced by mutual agreement of EU member states, possibly incorporating standards from organizations such as the BSI or ISO (see above). The manufacturer is ultimately responsible for placing the mark and verifying that their product meets essential requirements. For simple low-risk items, the manufacturer can directly place the CE mark. More complex devices, such as pacemakers, require detailed independent verification and certification by an independent organization, termed a Notified Body, who then issue certification to allow the placing of the CE mark. A flow chart illustrates how the system works and where the MHRA may be involved (Fig. 28.6).

Figure 28.6 The process of placing a CE mark on a medical device, and the interrelationships of various agencies (EU, European Union; CAs, Competent Authorities; GHTF, Global Harmonization Task Force; NCAR, National Competent Authority Report, a term coined by GHTF for international reports; FDA, Food and Drug Administration of the USA; TGA, Therapeutic Goods Administration, Australia; HC, Health Canada; MHLW, Ministry for Health Labour and Welfare, Japan).

The implications of this whole process, for the anaesthetist in particular, and for those involved in producing and modifying medical devices, are discussed in greater detail elsewhere.¹ Although recently passed into UK law, it may only be a short time before a CE mark is detectable on every piece of medical equipment in UK hospitals. CE marks are of course not limited to medical devices; other directives stipulate a wide range of marketed products from detonators to jet skis, though not pedalos!

Global harmonization

As well as its role in Europe, the MHRA is active on the wider international scene participating in the Global Harmonization Task Force (GHTF) along with Australia, Canada, the USA, other European countries and Japan. The work of the GHTF is to harmonize the more important regulatory aspects of medical devices, such as nomenclature and surveillance and vigilance protocols. The value of such work is evident, but it also provides a starting point for developing countries, allowing them to adopt standards that are time-consuming and difficult to set initially and are already in place around the world.

The lack of universal consent in health care can be startling. Manufacturers cannot agree the simplest things: the best colour to paint oxygen cylinders (ISO R 32/BSS 1319, first published in 1955, specified colours for medical gas cylinders – the fact that the standards have not been internationally adopted illustrates the voluntary nature of standards), and nor can we agree how to diagnose death.⁶

UK consumer advisory role

The wider role of the MHRA on the European and international scene has a direct impact on the working life of the anaesthetist. Work by the National Audit Office in 1999 on equipment purchase and maintenance in the UK revealed deficiencies and inconsistent practice. The MHRA has issued comprehensive guidance documents^7,8 to address this. Other bodies also provide advice for anaesthetists responsible for purchasing, maintaining and using medical devices within the UK and Ireland.⁹ National audit has been initiated under the auspices of the Controls Assurance Support Unit (CASU) to whom trusts are obliged to provide regular audit returns, based on details within the MHRA recommendations.

Adverse incident reportage

Problems with medical devices for one reason or another are common. Adverse incident reporting generates a large amount of information from various sources. Collating, analyzing and disseminating this data is a major role carried out by the MHRA. Concerns about medical devices arrive through a wide network:

Medical device-related adverse incidents are also reported to other bodies, such as the National Patient Safety Agency (NPSA). Data provided to the NPSA are sourced from anonymous critical incident reporting and analyzed to detect trends and identify areas to improve practice. Unfortunately, such overlap between authorities can be counter-productive; for example, NPSA data cannot be traced to source, and thus faulty equipment reports cannot be explored further with the reporter. Ideally, all medical device-related adverse incidents should be reported to the MHRA primarily and then additionally to other authorities as and when it is thought necessary: it may be insufficient to depend on channels of communication between organizations after the report is received. Electronic reporting by all parties is encouraged; the Manufacturers’ On-line Reporting Environment (MORE) enables rapid communication of alerts from companies. Adverse incident reports are investigated according to the level of risk and incident frequency. The investigation may lead to design changes and/or improved advice to users.

Safety advice

Information is disseminated in a number of formats to every UK hospital via its liaison officer. From 2003, the previous Hazard Notice, Device Alert, Safety Notice and Pacemaker Technical Note were replaced by a single format of notice: the Medical Device Alert. Details of the device concerned, the problem, who to distribute to, who must take action and what action to take are all included. Each alert is assigned one or more of the following categories:

Since 2004, a new system, the Safety Alert Broadcast System (SABS), sends out alerts by e-mail and requires a liaison officer to send confirmation of receipt and subsequent action. SABS may also contain alerts from the NPSA, NHS Estates and patient safety specific guidance from the Department of Health (Fig. 28.7). The advice contained within safety alerts is not enforceable, but should be viewed as reflecting best practice. As such, a decision not to heed all or part of a warning may require a robust defence.

Figure 28.7 The function of SABS, the Safety Alert Broadcast System. DH, Department of Health. NPSA, National Patient Safety Agency.

Trusts must have in place a system ensuring appropriate and timely dissemination of alerts and are obliged to take action by the deadlines dictated in the alert; failure to do this and to ensure that subsequent practice does not regress may result in repetition of harmful incidents and unnecessary injury.¹⁰ With increasing complexity of medical devices, particularly in the electrotechnical field, sudden failure remains a risk no matter how robust the design. In reporting such incidents, the importance of maintaining an intuitive manual back-up system is continually emphasized.¹¹

Other MHRA publications

The anaesthetist’s role

The main aim of incident reporting is to identify the potential for harm before actual harm occurs. The importance of prompt reporting and prompt action on device alerts is self-evident. Health-care workers in the UK are encouraged to report any device failure to the MHRA who aim to recognize patterns of problems or particularly serious isolated issues worthy of action. There is a natural tendency to under-report adverse incidents, particularly when the practitioner perceives some element of personal responsibility. This undermines the value of a system that is not seeking to apportion blame, but to learn from such problems and to direct manufacturers or practitioners in such a way that safe use of all devices is maximized. Reports can be communicated to the MHRA on-line, by e-mail, telephone, fax or post (see Appendix 2).

The reader may wonder whether anaesthetists feature with greater frequency in reports of equipment misuse and failure than other specialists. Certainly anaesthetists work in a device rich environment, but are generally well-trained and examined in the correct function and application of a wide range of equipment and are aware of the consequences of device failure or abuse. Just occasionally items neither directly connected to administration of anaesthesia nor operated by an anaesthetist can present us with a major problem.¹³ Continued vigilance is required from us and from our colleagues, to provide the information necessary to alert others to potential hazard from an increasingly complex array of medical equipment. The application of safety and conformity marks to an item does not mean it is incapable of being dangerous given incorrect use or unanticipated malfunction (Fig. 28.8). The MHRA provides an invaluable resource, aiming to promote the safe and effective use of medical devices within the UK and beyond.

Figure 28.8 A cause of equipment failure. Occlusion of anaesthetic breathing systems with extraneous items has been reported many times.

Acknowledgements

The author would like to thank the following people for their support: Miss Katie Taylor BA MIMI, Medical Photographer, QVH; Clive Bray BSc (Pharm) MSc MRPharmS and Tony Saint BSc MSc, both of the Medicines and Healthcare products Regulatory Agency.

Appendix 1

Appendix 2