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In addition to items for which the technical department has continuing responsibility, the inventory should also include items such as laryngoscopes and non-clinical items such as computers and printers. Although these may not need regular maintenance they should be included in the replacement programme. Every item of equipment, including consumables, must be identified by a unique number or batch number, and its location must be recorded. This is particularly important in the case of equipment recall due to a subsequent fault. All equipment records should be held on one central record keeping system where possible, e.g. software database managed by medical engineering department. If this is not possible, adequate cross referencing between record systems must be in place. This is particularly important where equipment may be moved between sites. 7
4. Standards 4.1 Medical Devices Directive and CE marking The Medical Devices Directive of the European Union prohibits the sale of medical devices within the EU that are not CE (Conformité Européene) marked. A CE mark indicates that devices meet all essential requirements of the Medical Devices Directive and are safe and fit for their intended purpose. However, the CE mark does not indicate clinical efficacy in all circumstances, therefore user assessment is vital for any purchase. 4.2 Standards To ensure suitability for a given task, most devices are manufactured to one or more verified standards. Standards are produced by CEN, the Comité Européen de Normalisation, or European Committee for Standardization, for mechanical devices, and CENELEC for electrical devices. Many devices used by anaesthetists use electricity to get mechanical results, and have to meet standards of both organisations. ISO, the International Organization for Standardization, and IEC the International Electrotechnical Commission, produce standards for the international market. The British Standards Institution is a national member of the European Organization, and its standards have gradually been integrated with their European equivalents. 4.3 CE marking and non-medical equipment CE marks for medical devices are awarded in four categories of differing stringency. However, devices intended for nonmedical use may also bear a CE mark that is indistinguishable from those on medical devices, but they may not be suitable for use as medical devices. An example is computer equipment, including display units and recording devices, which may have electrical leakage currents which far exceed the safe levels for use near patients with external pacemakers or central lines 8
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In addition to items for which the technical department has<br />
continuing responsibility, the inventory should also include<br />
items such as laryngoscopes and non-clinical items such as<br />
computers and printers. Although these may not need regular<br />
maintenance they should be included in the replacement<br />
programme.<br />
Every item of equipment, including consumables, must be<br />
identified by a unique number or batch number, and its location<br />
must be recorded. This is particularly important in the case<br />
of equipment recall due to a subsequent fault. All equipment<br />
records should be held on one central record keeping system<br />
where possible, e.g. software database managed by medical<br />
engineering department. If this is not possible, adequate cross<br />
referencing between record systems must be in place. This<br />
is particularly important where equipment may be moved<br />
between sites.<br />
7
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