P_CS_09 Medical Devices
The term "medical device" covers a wide range of products used every day in primary and community care settings. Devices include items such as needles, syringes, infusion pumps, endoscopes, examination gloves, dressings, walking sticks, and blood glucose meters. In other words, any instrument, apparatus, appliance, material or health care product, excluding drugs, used for, or by, a patient or service user for: -
- Diagnosis, prevention, monitoring, treatment or alleviation of disease.
- Diagnosis, monitoring, treatment, or alleviation of, or compensation for, an injury or impairment.
- Investigation, replacement, or modification of the anatomy or of a physiological process.
- Control of conception.
Medical devices will be procured, used, maintained, serviced, and decontaminated in accordance with national best practice as detailed by the MHRA, the National Health Service Litigation Authority [NHSLA], the Care Quality Commission and other national guidance as appropriate, e.g. HTM 01-05.
Most health care professionals, to support the care and treatment of patients, use medical devices and equipment every day. The objective of this policy is to provide a framework for the management of medical devices and minimise related hazards, to ensure that staff are properly trained and competent in the use of medical devices, that devices are maintained in a safe and reliable condition and recorded on a central database/inventory.
Risk assessments must be undertaken to identify any hazards associated with medical devices and steps taken to eliminate these risks. Where they cannot be eliminated they must be reduced to a minimum and appropriate control measures identified.