Equipment policy: meeting regulations

Diagnostic and therapeutic equipment is used every day by most healthcare professionals to support the treatment and care of patients. It is the responsibility of each organisation to ensure that healthcare professionals are using this equipment safely and for the purpose it was intended. The term ‘medical device’ encompasses medical devices as legally defined in the Medical Devices Regulations. This refers to an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which is intended by the manufacturer to be used for the purposes of: • Diagnosis, prevention, monitoring, treatment or alleviation of disease. • Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or physical impairment. • Investigation, replacement, or modification of the anatomy or of a physiological process. • Control of conception. A medical device does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means. This definition includes devices intended to administer a medicinal product, such as a syringe driver, or which incorporate a substance defined as a medicinal product, such as a drug-eluting stent. The delivery of safe and effective treatment in healthcare settings is dependent on the correct use of medical equipment in a range of applications. Interventions using medical equipment can optimise treatment, reduce length of stay and improve the patient experience of care. However, when used inappropriately, medical equipment carries the associated risk of causing harm to patients. It is, therefore, essential that all organisations have an overarching medical equipment policy and training programmes to minimise the risk of errors occurring.

Pressure to improve services

Healthcare organisations are constantly under pressure to improve processes and enshrine those processes within their organisational policies. The importance of policies to the individual, the department, and the organisation cannot be understated. The two core bodies that healthcare organisations in the UK are most concerned with are the National Health Service Litigation Authority (NHSLA) and the Care Quality Commission (CQC). The CQC audits against regulations approved by the UK Government. A summary of the regulations that impact on medical equipment management policy is described later in this article. The NHSLA sets risk management standards and operates an insurance scheme for member organisations. The objective of these risk management standards is to make the patient environment safer. If organisations are members of the NHSLA scheme (all NHS organisations must be members) the goal must be to reduce risk by providing evidence to the auditors that they are complying with the standards. Both the NHSLA and CQC base much of their audit criteria on information provided by the Medicines and Healthcare Products Regulatory Agency (MHRA). Many organisations struggle with changes in regulatory standards. Some organisations do not have systems in place that enable them to quickly change and implement policy. Therefore, changes made by Government may never actually get down to organisational level policy, in a reasonable timeframe. If an organisation does not have a professionally qualified person that is able to interpret the changes in regulatory standards and then update the organisational policy, then the changes required by Government will not be properly implemented. Even if the organisation does have a professionally qualified person able to interpret the changes in the standards and update the policy, this in itself does not mean the policy will be implemented.