Clinical engineering
Compliance assurance The ‘Health and Social Care Act’ regulates medical devices. Guidance is provided by the Medicines and Healthcare Products Regulatory Agency (MHRA), and compliance is monitored externally by the Care Quality Commission (CQC). Internally, the Trust should understand what is being bought, and how it is used, maintained, and reported. Internal compliance audits should be carried out and reported through the governance team to the executive board. A toolkit to provide Trusts with evidence of the compliance within their Trusts is now available.
Service and maintenance Safe and reliable planned preventative maintenance (PPM) and servicing of the medical equipment portfolio is a cornerstone of healthcare delivery. The Trust board should be assured that maintenance is being carried out in accordance with the regulations. Modern clinical technology management databases are capable of producing excellent dashboards to provide that assurance.
Original equipment manufacturer (OEM) contract management It is important to efficiently rationalise and manage OEM service contracts, delivering economies of scale and best value, with a single point of contact to reduce your management overhead.
Training - a key element for improved patient care International data shows that user errors are one of the main causes of incidents
involving medical equipment. Training of users is, therefore, a fundamental element for the correct and safe utilisation of medical equipment. Moreover, skilled users make better use of their equipment, increasing productivity and reducing failures and maintenance needs. Training and (continuing) education are important components of standardisation, to ensure safety. Any programmes standardising medical practices, and the use of medical devices, could include training curricula, including credentialing methods for the post- training period (e.g. every half year). Implementing such measures as part of an
overall clinical technology management strategy will help to reduce errors and improve care. The investment in the clinical engineering workforce is also recognised as an essential requirement to ensure that the profession retains and recruits the appropriately trained engineering professionals and technicians to deliver these services in an increasingly technology-led environment.
Cyber security The NHS has recognised the importance of the health of the connected medical devices and the new Data Security and Protection Toolkit encourages all Trusts to ensure compliance. The expectation is that all organisations that have access to NHS patient data or systems must use the toolkit to provide assurance that they are practising good data security. Also, new software components have been
added to medical equipment, such as Health Level Seven or HL7, which refers to a set of international standards for transfer of clinical and administrative data between software
Figure 6
applications used by various healthcare providers. Hospitals and other healthcare provider
organisations typically have many different computer systems used for everything from billing records to patient tracking. All these systems should communicate with each other (or “interface”) when they receive new information, or when they wish to retrieve information, but, at present, not all of them do. HL7 defines a series of electronic messages to support administrative, logistical, financial as well as clinical processes.
Cyber security is also vital to ensure patient data is not compromised. Companies such as Cynerio are working with leaders in clinical technology management and NHS Trusts to put in diagnostic and management solutions to address these current issues. The reporting and management of cyber security needs to be included in the clinical technology management to the executives. Clinical technology management is therefore a combination of multiple inputs and is the terminology used to manage medical devices and report to hospital boards on its health and compliance.
Strategic opportunities to drive improvements l Full asset management: a complete one-stop clinical technology management solution, can bring together management, procurement, maintenance, planning and training for all medical equipment.
l Compliance assurance: regular audits should provide executive assurance that technology is being maintained / managed; users should be effectively trained in accordance with MHRA guidance to meet CQC regulations.
l Review to improve: reducing downtime and ensuring the right equipment is in the right place at the right time.
Figure 7 40
www.clinicalservicesjournal.com I September 2023
l Equipment library services: these enable more efficient sharing of resources and new ways of working that will cover day-to-day
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