4.1 The safety of medical devices in the UK is the responsibility of the Medical Devices Agency (MDA) under the Medical Devices Regulations. Devices which have a Comité Europa (CE) marking on their products have been assessed to be safe and fit for purpose, when used in accordance with their instructions for use.
Medical devices which are not CE marked cannot be placed on the European market and therefore cannot be used by NHSScotland.
4.2 By definition, a safer device incorporates engineering controls to prevent needlestick injuries, before, during or after use through built in safety features (UNISON, 2000). The term "safer device" is broad and includes many different types of needle. The common feature is that they aim to reduce the risk of needlestick injuries to those using the device. The majority of safer devices have not been rigorously evaluated in clinical practice, although there are US studies which show the effectiveness of some devices.
4.3 A decision to select the most suitable product for a particular clinical need must rest with individual Trusts, through their appropriate risk assessment process. The Health Technology Board for Scotland in conjunction with the MDA should establish a programme to evaluate the clinical and cost effectiveness of safer devices as a matter of urgency.
4.4 There are currently only a limited number of safer devices available on the market in the UK that have CE markings and these do not cover all clinical situations. The Group and the MDA are not aware that any of these devices have been subject to systematic evaluation in clinical practice within the NHS workplace or what their failure rate might be. It has not been possible to make recommendations regarding particular devices due to the lack of information about their effectiveness and application. However, given the awareness of healthcare staff of the devices and the availability of some devices, the group have identified a number of US-based websites providing guidance on how to assess effectiveness of new devices. UNISON also issues a regularly updated list of manufacturers with products available in the UK.
4.5 Evidence from the United States suggests that effectiveness levels of safer needles range from 29-89 %. This means that healthcare workers are still at risk when using these devices and good practice needs to be followed at all times. For this reason it is essential that all staff are made aware that the use of safer devices does not automatically mean that all risk is eradicated. NHSScotland Organisations considering safer devices should first test and evaluate them.
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Recommendation 23 |
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Recommendation 24 |
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Recommendation 25 |