DB9801

This publication was issued by the Medicines and Healthcare products Regulatory Agency (MHRA) in January 1998 and relates specifically to the management of medical equipment.

The scope of the bulletin explains the recent changes in legislation, especially with regard to the CE marking of medical devices. Definitions are provided and terms used, drawing clear distinctions between the clinically trained and technically trained staff, who are involved with the use, maintenance and supervision of medical devices.

The overall aim of this bulletin is to ensure that when a medical device is used, it is:

EEC directive 93/42/EEC

(CE marking of medical devices)

This is the most important directive as far as the majority of clinical staff are concerned. It covers devices ranging from CT scanners to hip joints. The directive came into force in January 1995, and had a transitional period which expired in June 1998. The directive is now mandatory for all manufacturers of medical devices.

This directive has now been in force since June 1998 and relates to the manufacture, safety and use of medical devices.

A definition of a medical device.

A medical device is basically any health care product which is used for a patient in the diagnosis, treatment, prevention or alleviation of illness or injury. It could be a sophisticated CT scanner, or it might equally be a hip-joint. An ecg machine is a medical device, but then so is a wooden spatula.

National Audit Report (HC475)

The Management of Medical Equipment in N.H.S. Acute Trusts in England
Ordered by The House of Commons

Overall Conclusions :

The report examines the performance of acute trusts with regard to all medical devices connected to patients. Overall, more needs to be done by Trusts to allocate clear responsibility for medical equipment at board level.

The report recommends the use of engineering management in the purchase, acceptance testing, installation, repair and maintenance of medical equipment. This should help to reduce expenditure and increase safety, thereby reducing the risk of incidents and litigation.

CE Marking

CE marking means that a manufacturer claims that his product satisfies the requirements essential for it to be considered safe and fit for its intended purpose. This means that, before applying CE marking to a device or its packaging, a manufacturer must go through one or more 'conformity assessment procedures' to confirm hat the design/ production of the device meets all the relevant requirements laid down in the directives. The stringency of these procedures depends on which directive applies and on the classification of the medical device concerned. Not all devices pose the same degree of potential risk. For the medical device directive, products will be divided into different classes of risk from class1 (low risk) to class3 (high risk) . This classification system allows the level of control applied to any particular device to be proportional to its inherent risk. All devices covered by the active implantable medical devices directive are equivalent to class 3. Class 3 devices (such as heart valves) will need to satisfy much more stringent requirements than class 1 devices (such as tongue depressors).

Active Implantable Medical Devices Directive

The active implantable medical devices directive covers all powered implants, or partial implants which are left in the human body, including heart pacemakers, implantable defibrillators, neuro-muscular stimulators and implanted drug infusion devices. Clinical investigations for these non CE marked devices must be approved by the competent authority. This directive came into effect in January 1993.

EMC Directive (89/336/EEC)

The EMC directive is a general directive which provides for protection requirements governing electromagnetic disturbance emitted by a wide range of electrical and electronic apparatus. It came into effect in Europe in January 1992. However, the EMC directive provides that, where harmonised protection requirements are subsequently set for particular types of apparatus by product specific directives, then the EMC directive ceases to apply to such types of apparatus when these other directives enter into force.

The directive has been implemented in the UK by the electromagnetic compatibility regulations 1992 (SI 1992 no.2372) Whilst medical devices were excluded from the scope of these regulations in accordance with the European guidlines on the application of EMC directive, because it was expective that the directives concerning those devices would be in place by this time, they were brought within the scope of the EMC regulations in December 1994 by the electromagnetic compatibility (ammendment) regulations 1994 (SI 1994 no.3080).

The EMC directive as amended by directive 92/31/EEC, contains transitional provisions whereby apparatus covered by it, may be placed on the market or put into service between 1 July 1992 and 31 December 1995 in accordance with national regulations in force 30 June 1992. In the UK the national regulations which were in force on 30 June 1992 and are relevant in this case, are the wireless telegraphy (control of interference for electromedical apparatus) regulations 1963 (SI 1963 no. 1895). These regulations apply to a very limited range of electromedical equipment.

Low Voltage Directive (73/23/EEC)

The low voltage directive 73/23/EEC concerning electrical equipment designed for use within certain voltage limits (known as the low voltage (LV) directive) covers equipment designed for use with a voltage rating of between 50-1000 volts for alternating current and between 75-1500 volts for direct current. It was implemented in the UK by the electrical equipment (safety) regulations 1994 (SI 1994 no.3260).

The regulations came into effect in 9 January 1995 and provide for a transitional period to 31 December 1996. The regulations do not apply to equipment for radiology and medical purposes. Accordingly the regulations will apply to, for example, items of laboratory equipment such as centrifuges and analysers which have no specifically intended medical purpose.

Quality Controls

The N.H.S. is currently carrying out a review of it's procedures to ensure the proper management of medical devices. The cost of litigation to the N.H.S. is calculated to be in the region of 7% of the annual budget (and rising) As a result, the importance of medical devices management cannot be underestimated.

The latest guidelines are part of the National Services Frameworks for the NHS. Detailed information can be found at: The NeLH National Service Frameworks Zones. Ultimately, chief executives are accountable for having in place an effective system of risk management and internal control (Under HSC 1999/123).