The Government introduced new legislation in 2010 impacting on medical devices, because it recognised that there are problems with managing medical devices that pose risks to patient safety and result in increasing costs.
In Figure 1, the outer circle shows the impact of new government policy on UK regulations and ultimately the Trust, and the inner circle shows the medical devices manager's responses as the person responsible for policy in this area. This new healthcare policy relates to the safe use of medical technology. As a result of this new legislation, a new regulation was approved in October 2010 as the Health and Social Care Act Regulation 16, Outcome 11, which is enforced by the Care Quality Commission (CQC) and specifically relates to the safety, and suitability, and safe use of medical devices (Care Quality Commission, 2010).
The CQC monitors compliance with the Health and Social Care Act regulations and government policy, thereby allowing the government to understand compliance and subsequently review and improve government policy.
The National Health Service Litigation Authority (NHSLA) sets the risk management standards for the National Health Service (NHSLA, 2010). The Medicines and Healthcare Products Regulatory Agency (MHRA) regulates specific medicines and healthcare products (MHRA, 2006). The European Union (EU) regulates the manufacture of medical devices (EU Commission, 1993). These are the four key external governance and regulatory areas that influence the Hospital's medical devices policy. These external influences that impact on the Hospital's medical devices policy are shown below.
Figure 2: External Governance and Regulatory Demands
If any of these four external organisations issues new standards or regulations, the Hospital must ensure the medical devices policy is updated and then implement those changes, as shown in Figure 1.
Consequently, medical devices managers must ensure that the view of these authoritative bodies are included within, and lead to an improved, robust, medical devices management policy for the Trust that will ensure medical devices are managed more safely, thereby ensuring patients have access to safe and effective good-quality medical devices. This is vital for patients and the staff operating medical devices. The Trust, with the assistance of the medical devices manager must determine which staff require training in the safe use of devices to benefit clinical care. Moreover, the patients at the Hospital expect to be treated with up-to-date, well maintained, equipment, allowing them to have the best chance of recovery.
Nurses and clinical staff want the best equipment available to do exactly that, although there is a limited amount of money available to enable regular replacement of the equipment. The management of medical equipment inventories requires professional managers who are up to date with the latest standards and regulations, and are able to act as the interface between the medical devices policy and the regulations.
- Care Quality Commission, 2010. Regulation 16 Outcome 11 Safety, availability, and suitability of equipment. [Online]
Available at: http://www.cqc.org.uk/_db/_documents/PCA_OUTCOME_11_new.doc
[Accessed Dec 2010].
- EU Commission, 1993. Medical Devices Directives. [Online]
Available at: http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices/
[Accessed 21 October 2012].
- MHRA, 2006. Managing Medical Devices: Guidance for healthcare and social services organisations,
London: Medicines and Healthcare Products Regulatory Agency. NHSLA, 2010. NHSLA Corporate. [Online]
Available at: http://www.nhsla.com/Corporate/
Author: John Sandham - March 2014