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Clinical engineering in the United Kingdom
Chapter 7
Clinical engineering in the United Kingdom Daniel Clark Clinical Engineering, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom; Faculty of Engineering, University of Nottingham, Nottingham, United Kingdom
Introduction Modern health care is ever more dominated by technology: technology has a role in hospitals and in community settings; in acute episodes and chronic care; and indeed, technology can be used to prevent people becoming unwell in the first place and help us all live longer and healthier lives. New technologies have the potential to revolutionize the way we manage health and well-being now and in the future. Research and development into new healthcare technology; the application of this technology in clinical settings and managing it to ensure it continues to work safely and effectively once deployed, requires the skills and experience of clinical engineers. The profession has grown from early days supporting pioneering research to being a vital resource supporting most healthcare provision in the UK. Despite this success, clinical engineering teams remain largely unsung heroes and need to continue to progress the profession’s profile and gain further recognition for its value to health care.
What is in a name? Well, that which we call a rose, by any other word might smell as sweet but a profession finds it hard to define its identity and raise its profile when it cannot agree on its own name. Over the years many terms have been used in the UK to describe the functions of the application of engineering to health and well-being: bioengineering, biomedical engineering, clinical engineering, medical equipment management (MES), electro-biomedical engineering (EBME), medical equipment servicing units (MESU), rehabilitation engineering, clinical instrumentation, biomechanics, and medical engineering amongst many others. The debate has not so much raged as bubbled along but today in the UK there is relatively broad agreement that two terms encompass the field: Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00007-9 Copyright © 2020 Elsevier Inc. All rights reserved.
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Biomedical engineering. The overarching term for engineers who use traditional engineering expertise to analyze and solve problems in biology and medicine, provides an overall enhancement in health care. It encompasses a range of subspecialties including biomechanics (including prosthetic devices and artificial organs); bioinstrumentation (including imaging system, sensors, and monitoring systems); biomaterials (including tissue engineering and regenerative medicine); systems physiology and physiological modeling. Clinical engineering. A separate but linked discipline, sometimes seen as a subspecialty of biomedical engineering, with a direct focus on the adoption, application, and management of healthcare technology in the clinical environment (and in the UK, predominantly in the hospital setting).
Of course, there is a dependency between and across these areas and even a degree of overlap. Moreover, the nature of these rapidly evolving fields makes definitions difficult but these two broad terms help describe the disciplines. And old habits, of course, die hard: the terms EBME, MESU, and others will still be heard in many hospitals across the UK. In general, biomedical engineering tends to the work at the more research and development end of the product lifecycle; clinical engineering at the more adopt, implement, and improve end. In general, biomedical engineers tend to work in academia, research facilities, and industry; clinical engineers in hospitals and other healthcare settings. But in all cases, engineering principles, good communications, multidisciplinary working, and a desire to improve the health and well-being of people is common. This chapter concentrates on clinical engineering in the UK and covers the early development of the field; the organization and management of clinical engineering services and the current range of services provided within the National Health Service (NHS); the standards and regulations in place covering clinical engineering services and the workforce delivering these services, their training and registration. 63
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Early years The application of technology to health care is not new. One of the earliest examples of medical device technology is a prosthetic toe that dates from about 1000 BCE (Before Common Era) and is currently on display in the Cairo Museum in Egypt. It is made from cartonnage, a sort of papier maché made using linen, glue, and plaster and demonstrates the engineering ingenuity of the time, though the Egyptians probably did not refer to the creator as a clinical engineer. Indeed, the first reported use of the term was not until much more recent times when cardiologist Cesar Caceres first coined the term (Landoll and Caceres, 1969) in 1969. A decade earlier, in 1959, a group of engineers, physicists, and physicians met at the Second International Conference of Medical and Biological Engineering, in the United Nations Educational, Scientific and Cultural Organization (UNESCO) Building, Paris to create an organization then entitled the International Federation for Medical Electronics and Biological Engineering (IFMBE). At that time there were few national biomedical engineering societies, and certainly not one for the UK, so individual workers in the discipline joined as Associates of the Federation. Later, as national societies were formed, these societies became affiliates of the Federation. The following year, the conference was held in London and served as the catalyst for the formation of a society to serve the needs of biomedical engineers in the UK and the biological engineering society (BES) was established in 1960. The name of the society reflected the aim of representing the widest possible group of multidisciplinary professionals working in the application of engineering to biological systems. In 1963, the BES was one of the first national societies to affiliate with the IFMBE and provided a focus for biomedical engineering activity in the UK. In 1995 the BES merged with the Hospital Physicists’ Association (HPA) to form what is now the Institute of Physics and Engineering in Medicine (IPEM) to create a single professional body representing the interests of physicists and engineers in medicine. In part this merger was a pragmatic marriage creating a larger and more resilient new institution to better support its professions; in part it reflected a general coming together of these teams at local level in hospitals across the NHS; but mostly this was an opportunity to integrate education, training, research, and methods of service delivery. The first hospital-based departments dedicated to engineering started to appear in the early 1970s. Before that, engineers employed in healthcare applications tended to be based in academic research facilities; within clinical departments in support of specific research programs or within medical physics departments in larger hospitals. The UK developed significant research strengths in biomedical engineering during this time developing many healthcare technologies in worldwide use today. Specific examples of these pioneers of biomedical engineering include (IPEM, n.d.): Sir Godfrey Hounsfield:
an electrical engineer who was awarded the Nobel Prize for developing X-ray computed tomography (CT) scanning; Sir Peter Mansfield: this Nobel Prize winner played a pivotal role in the development of the medical imaging using magnetic resonance imaging (MRI) and functional MRI; Professor Peter Wells CBE (Commander of the Order of the British Empire): awarded the Royal Medal in 2013, also known as the Queen’s Medal, for his pioneering work in medical ultrasound.
Organization of services and management arrangements During the same period there was an increasing dependency on medical equipment in healthcare provision and by the late 1960s and early 1970s, hospitals were becoming aware of the need to manage this equipment. Responsibility for medical equipment generally rested with the local Hospital Engineering Department (which would now be called the Estates Department) but there was the recognition that these teams—who managed fixed plant and nonmedical equipment—had neither the systems nor capacity to address the growing issue. Significant debate followed as to the best way to address the issue with two schools of thought prevailing: (1) that Hospital Engineering Departments should continue to manage all equipment, including medical equipment, and should be expanded and developed to facilitate this and (2) that biomedical engineers (including the newly termed Clinical Engineers) should establish new teams within existing Medical Physics Departments. In general, the larger hospitals that already had bioengineering activity usually based around research tended to develop services within Medical Physics Departments whereas the smaller hospitals tended to develop services within existing hospital engineers (estates) departments. This division is still apparent today with some hospitals, generally the major teaching hospitals, running engineering or scientifically led services usually out of medical physics and clinical engineering departments while the majority, generally smaller district general hospitals provide technically led services managed through estates departments.
Clinical engineering services in the UK Over the years, the development of different management arrangements in different hospitals led to a range of service provisions across the NHS: it is probably true to say that no two hospitals provide exactly the same services. It is therefore convenient to describe UK-based clinical engineering services initially in high-level terms. Fig. 1 describes the elements that a healthcare provider (hospital) should have in place to safely and effectively manage healthcare technology. This can be broadly grouped into three themes: healthcare technology management; healthcare technology innovation; and healthcare technology applications all of which require systems of governance to ensure patient safety.
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FIG. 1 Range of clinical engineering services.
Healthcare technology governance The paramount responsibility of the clinical engineering service is to ensure good governance of technology, ensuring the organization is compliant with national regulations and standards, and ultimately that patients are kept safe. The exact mechanism through which this is delivered will vary depending on the size of the hospital and the clinical engineering service but will include systems to respond to external and internal safety alerts; services to support investigations into clinical incidents involving medical devices; system to monitor, review interpret and implement relevant legislation, regulations, standards, and best practice guidance and support for corporate, hospital-wide groups developing healthcare technology strategy and policy.
Healthcare technology management Modern health care is hugely dependent on the availability and management of the medical equipment which is, perhaps, the core function of clinical engineers. Clinical engineers will be influential in, and indeed sometimes responsible for, medical equipment resourcing: managing, or being involved in, the acquisition of new medical equipment; ensuring the needs of the patients are met; ensuring that the equipment is appropriately evaluated before
a cquisition; ensuring that equipment is compliant to appropriate legal and regulatory standards and that when delivered to site that the equipment is safe and working correctly before it is used on patients. Increasingly, clinical engineers will also manage the availability of equipment through central stores or libraries, ensuring the right equipment is available at the right time and in the right condition. Medical equipment servicing ensures that the essential performance and safety of the equipment is maintained over its lifetime helping to support optimum clinical care for patients. Clinical engineering servicing teams maintain most medical equipment and place contracts with external servicing agents where appropriate. Servicing tasks will include acceptance checks to ensure equipment is safe and working correctly when first delivered, preventative maintenance to ensure equipment continues to perform as the manufacturer intended and repairs. Often, servicing teams are grouped by equipment portfolio which, depending on the size and nature of the hospital might include: general medical equipment; theaters and anesthetics, renal; critical care; radiotherapy and radiology. A key element to healthcare technology management is maintaining and developing records. Good inventory management is not only essential to manage the current equipment base but provides valuable insight for
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replacement programs and financial management of vital hospital assets. Most clinical engineering departments use one of a number of commercially available inventory systems (databases) but, unfortunately, there is a lack of consistency and standardization as to how these inventories are used leading to difficulties in national reporting and benchmarking.
Healthcare technology innovation While genuine ‘blue sky’ research (like that of Hounsfield, Mansfield, and Wells) is rare within NHS clinical engineering services these days, Clinical Engineers nonetheless make significant contributions to medical technology innovations in various ways. Some departments still run engineering and instrumentation groups that provide a bespoke technical solution to clinical research projects. Operational pressures and finances have made these services hard to sustain. The 2017 changes to the medical devices regulations (MDR2017/745, Regulation (EU) 2017/745 of the European Parliament and of the Council, n.d.) in Europe might, perhaps counterintuitively, present an opportunity for these services because well run NHS clinical engineering teams designing devices or elements of devices under appropriate quality systems will become more attractive to NHS clinical research projects than outsourcing to commercial or academic partners. While the number of centers designing and developing new devices is small, most departments will be facilitating clinical research by supporting the introduction of new and novel technologies as part of clinical research projects. Health technology assessment (HTA) is a developing role for clinical engineers. Traditionally, clinical engineers have not been active in this relatively new discipline but increasingly their skills and experiences are being recognized as valuable in this area. Moreover, as the focus of healthcare systems becomes more and more centered on financial sustainability, the role of new technologies to support more cost-effective health care is being highlighted. Clinical engineers, with their knowledge of technology, their systems-based methods, and their analytical skills are being seen more and more as key workers in this developing field.
Healthcare technology applications Clinical engineers play both a direct and indirect role in the applications of healthcare technology. Directly, some clinical engineers will be routinely supporting clinical services by providing technical and scientific input into clinics and procedures. This often overlaps with what is traditionally referred to in the UK as physiological measurement and includes services such as audiology, ophthalmology, electro-
diagnostics, clinical neurophysiology, human performance (gait analysis), and critical care technology. In some hospitals, these technical and scientific services are provided by staff employed directly with the clinical team, in others by staff in dedicated teams within medical physics services and in some centers by clinical engineering teams. Howsoever this service is provided, the staff tend to be based locally within the clinical areas and work directly with clinical staff and patients. Another area of direct clinical support that can involve clinical engineers is nonionizing radiation. It is perhaps more common in the UK for these services—which include lasers, microwaves, ultrasound, ultraviolet, thermometry, and diathermy— to be provided by the radiation physics teams. More generally, whenever new technology is introduced into the healthcare system, clinical engineering teams are involved in supporting clinical teams and ensure they optimize its performance. This can take the form of assessing the technology and working with the clinical teams to get the configurations correct, through to helping redesign the clinical pathway to account for the new technologies capabilities. Ordinarily, once the clinical service is established, the clinical engineer reduces or ends their involvement and the routine service is provided by the clinical teams.
Rehabilitation engineering A specific mention needs to be made to rehabilitation engineering. Sometimes this service is provided by the clinical engineering team but more often this is a standalone department, usually based with the multidisciplinary rehabilitation team that also includes physiotherapists, occupational therapist, speech and language therapist, and mobility teams. Rehabilitation engineers have very similar training and skills to clinical engineers but dedicate their service toward assessing and responding to the needs of people with disabilities. They provide standard and customer-made assistive technology including specialist seating; wheelchairs; artificial limbs; electronic communicators; and robotic aids. Indirectly, clinical engineers support the application of technology by providing medical devices training and competency management which can range from fairly small training and assessment centers on a limited number of medical devices through to full proficiency management covering most equipment used in the hospital across all staff groups. Increasingly, the NHS inspection bodies (see below) are looking for evidence that clinical staff are competent to use the equipment in their areas. Clinical engineers, with their extensive experience of equipment types, are well placed to manage systems to train and assess competency.
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Managing standards, regulations, and performance Regulations At time of writing, the UK medical devices market was regulated, in common with the rest of Europe, under three principle Directives: the Medical Devices Directive (EC 93/42/ EEC); the Active Implantable Medical Devices Directive (EC 90/385/EEC), and the In-Vitro Diagnostic Medical Devices Directive (EC 98/79/EC). The UK Competent Authority—the Medicines and Healthcare products Regulatory Agency (MHRA)—acts as the regulator for the medical devices industry. The MHRA ensures that manufacturers meet UK legislation (MHRA, n.d.) by monitoring incidents, approving of clinical trials and clinical investigations, auditing of UK notified bodies, maintaining the register of manufacturers of class I medical devices, and taking compliance and enforcement action where necessary. The MHRA also produce guidance intended primarily for people working in hospitals and community-based organizations that are responsible for the management of reusable medical devices, to help them set up and develop systems that promote the use of the medical devices for safe and effective health care (Managing Medical Devices, 2014). This guidance document (and its predecessors, Managing Medical Devices, 2006; DB 2005(03), 2005) form the basis of all clinical engineering services in the UK, outlining the principles, systems, and practices required for safe and effective management of medical devices. This guidance also influences the inspection bodies in the UK with respect to medical devices management. Changes to the European legislative framework for medical devices are being implemented with the current three Directives becoming two new Regulations: Regulation on Medical Devices (EU 2017/745) and Regulation on In vitro Diagnostic Medical Devices (EU 2017/746) with transition periods of 3 years (until 2020) and 5 years (until 2022), respectively. Clinical engineering departments are likely to have to adapt their services to meet these newer requirements but again, guidance from the MHRA is expected. Additionally, of course, at the time of writing, the UK is planning to leave the European Union and as such the legislative framework is now uncertain. The expectation is that the UK will continue to follow the EU regulations under a mutual recognition agreement but the future here is still unclear.
UK (NHS) healthcare inspection regimes The vast majority of health, well-being, and social care services provided to people in the UK is delivered by the NHS. A single system is in place across England and Wales, with slightly different approaches in Scotland and Northern
Ireland, but all essential an NHS provision. Additionally, there are a few smaller private and charity-based providers. All these services are subject to a single regulatory system and the principal regulatory body for all health service providers is the Care Quality Commission (CQC), an independent regulator of health and adult social care. The CQC make sure that health and social care services provide people with safe, effective, compassionate, high-quality care, and support care services to improve. They register care providers (a care provider must be registered in order to provide its services); inspect and rate services (Outstanding, Good, Requires Improvement, or Inadequate); take action to protect people (by issuing improvement notices for care providers where required or even by removing their right to provide services), and publish their findings. There is no national body with specific responsibility for inspection or regulation of clinical engineering services. Rather, these services are assessed, by the CQC, in terms of the support they provide to the clinical teams they serve. The CQC use available standards and best practice guidance when inspecting; in the case of clinical engineering, this tends to be the guidance produced by the MHRA (Managing Medical Devices, 2014). Although clinical engineering services are only a tiny fraction of everything that the CQC has to inspect, they tend to get a higher profile than their size might suggest because almost every patient episode will involve one or more medical device which can lead the inspector to ask questions about the clinical engineering teams. From April 2016 a second inspection body also took effect across the UK healthcare system. NHS Improvement (NHSi) is responsible for overseeing NHS organizations and offers the support these providers need to give patients consistently safe, high quality, compassionate care within local health systems that are financially sustainable. By holding providers to account and, where necessary, intervening, NHSi help the NHS to meet its short-term challenges and secure its future. While not strictly a regulator and without the powers to stop organizations from providing care services, they nonetheless hold significant influence over funding and their inspections, therefore, carry great weight. Like the CQC, NHSi does not specifically inspect clinical engineering services but again, because the impact of our services is so wide across all clinical teams, our roles can have a disproportionately large effect on any inspection.
Quality systems It is increasingly common for UK clinical engineering departments to operate within a quality management systems (QMS) with ISO 9001 being the primary standard. The quality management establishes the framework for how a service manages its key processes and helps ensure processes meet recognized standards, clarifying objectives and avoiding damaging and expensive mistakes. In the absence
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of a national inspection body for clinical engineering services, operating a QMS also enables departments to demonstrate their adherence to MHRA and other relevant guidance when inspected by the more generic CQC or NHSi inspectorate. Departments that manufacturer devices (which are relatively rare in the NHS) or are active in supporting design and development of medical devices also tend to be covered by ISO 13484.
Benchmarking Benchmarking can be an important part of performance management enabling different services to compare their processes and performance metrics to industry bests and to best practices from other departments. The diverse range and size of clinical engineering departments in the UK can make this challenging but the NHS National Performance Advisory Group (NPAG) support a number of benchmarking activities across many clinical engineering departments. This is not a requirement under any national regulatory or directive but supports best practice and service improvement.
Workforce Career and training pathways Clinical engineering comes under the umbrella term of healthcare science within the NHS. A career and training pathway for healthcare science is managed nationally through NHS Health Education England. Fig. 2 below shows the stages of this pathway generalized for all healthcare science professions (NHS Health Education England, 2018). The intention is that individuals can enter at one of three points as indicated on the diagram (dependent on academic qualification and experience) but can also travel up through the pathway supported by workplace and academic training programs. In theory, an individual can enter at the lowest point on the diagram and work themselves up to consult level. At the “Entry” Level, an individual might come directly from school or college or be appointed into a clinical engineering team from another career but without relevant qualifications or experience. Staff at this point would generally be referred to as Assistant Clinical Technologists or Associate Clinical Technologists. Their roles would vary depending on the department size and scope of service but might include a technical support function; basic user and technical maintenance; general workshop support roles. Clinical engineering assistants work toward vocational qualifications, often apprenticeships are used as a training route. They might also be trained through a higher-level apprenticeship, foundation degree or diploma. A national learning and development framework is being developed by Health Education England. Once implemented, the modular framework will provide a national learning structure for
assistants and associates with vocational awards and qualifications. However, this is not yet available for clinical engineering assistants and Associates. At the “Direct entry” level, an individual might come via progression from the clinical engineering assistant or associate route or might come directly from college with appropriate qualifications. Individuals might also be appointed from other careers provided they have relevant experience. Generically, this stage of the career pathway is termed the healthcare science practitioner, but within clinical engineering they are generally referred to as Clinical Engineering Technologists [or sometimes Clinical Engineering Technicians (EngTech)]. Healthcare science practitioners are now trained through NHS approved and accredited BSc honors degrees through the Practitioner Training Program (PTP) in various themes of healthcare science. Offered by a number of universities across England, the programs include academic learning and work-based training. The 50+ week work-based training element, supported by curricula, is spread over 3 years, involving broad scientific training in the first 2 years with an increasing focus on a chosen specialism during year 3. The PTP scheme is still maturing and is not generally well adopted within clinical engineering services. At the “Graduate direct entry” level, an individual usually comes post-university degree and would join the Scientist Training Program (STP). This is a 3-year program of work-based learning, underpinned by a university accredited master’s degree. Trainees are employed by an NHS hospital for the duration of the program and will be required to spend time in a range of settings, before specializing in the last 2 years of the program. Within clinical engineering, these specialisms cover Device Risk Management and Governance; Clinical Measurement; Design and Development; and Rehabilitation Engineering. The STP national recruitment process is managed by the National School of Healthcare Science. Generically, this stage of the career pathway is termed the trainee clinical scientist, but within clinical engineering they are generally referred to as trainee clinical engineers. Upon successful completion of the STP staff would become clinical engineers and be expected to join the nation register (see state registration below). Beyond this level, a further national training scheme is also available: the Higher Specialist Scientific Training (HSST). This is a 5-year program available to registered and experienced clinical scientists (including clinical engineers) who wish to train and become eligible to apply for consultant clinical scientist (including clinical engineer) posts. The program is equivalent to the standards of training undertaken by medical postgraduate trainees. Staff can join the program either as a direct entry (apply for a new post) or as an in-service entry (nominated by their current employer).
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Clinical academic career
Consultant clinical scientist
Higher Specialist Scientist Training (HSST)
Graduate direct entry Scientist Training Programme (STP) MSc Clinical science and work based programme
Statutory regulation (clinical scientist)
Clinical scientist Accredited Expert Scientific Practice
Potential equivalence and progression route
Direct entry Practitioner Training Programme (PTP) integrated BSC (Hons) Healthcare Science and statutory regulation
Biomedical scientist or accredited voluntary registration
Accredited Specialist Scientific Practice
Healthcare science practitioner
Potential equivalence and progression route
Entry Learning and development framework
Accredited voluntary registration
You can enter healthcare science at any of these levels
Healthcare science associates and assistants
Accredited Additional Scientific Practice
Source: www.dh.gov.uk
FIG. 2 Healthcare science career and training pathway.
Profile The number of staff and the roles they undertake will vary widely across clinical engineering departments depending on their size, the type, and size of the hospital they support, and the range of services they are involved with. The following is therefore merely indicative of what a typical department might look like, should such a thing exist.
Clinical engineers Generally, few in numbers—many departments will have one or two engineers and even larger departments rarely have more than 10—clinical engineers will work across all aspects of clinical engineering services. They provide support and leadership roles for most clinical engineering activities, being responsible for service delivery, practice,
and policy. They often have hospital-wide responsibility for medical devices governance and patient safety. Additionally, they often play lead roles in healthcare technology innovation, either directly through their own research or by facilitating technology-led research programs in hospitals.
Clinical engineering technologists The largest staff group, clinical engineering technologists are generally the mainstay of a clinical engineering department, predominantly working in the healthcare technology management field, and in servicing workshops, in particular. Some staff technologists, of course, will also be involved with the application of technology—particularly in clinical support roles—and others will support research and innovation activities.
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Assistant clinical engineering technologist Often seen as an entry-level role or apprenticeship, assistant technologists are an increasing staff group with clinical engineering services. Most departments try to have a small number of these roles to help future workforce requirements. However, assistant technologists provide a very useful role in themselves, often supporting the servicing functions of the department.
Equipment library staff Staff supporting equipment library functions in hospitals can be porters, assistant technologists, and supervisors. This very operational role not only involves the logistics side of ensuring equipment provision across the hospital but usually also includes basic user and technical servicing elements, particularly equipment cleaning, inspection, and battery management.
Nurses Clinical engineering services often provide training and competency management support for clinical users of medical equipment. This role might be delivered by engineers, technologists or nurses. Nurses bring clinical credibility and understanding to the role and when supported by a technical department can often enhance the service quality considerably.
Administration By the nature of their activities, clinical engineering departments have a significant need for good administration systems and business support staff. Often, this team is the essential glue that holds services together providing financial support, procurement, stock management, and record-keeping.
Health technology assessment analysts A growing role for clinical engineering HTA is making an increasing impact on health technology provision. Specialist HTA analysts remain rare in UK clinical engineering services but are likely to increase in the future.
Managers Most clinical engineering services are managed by clinical engineers or clinical engineering technologists. It is rare that a department would have a dedicated, nontechnical manager. However, larger departments often employ business managers to help with the increasing financial and contractual arrangements.
Clinical engineering certification There is no Clinical Engineering Certification scheme currently in operation in the UK. For a period in the 1980s and
1990s, attempts were made to introduce a scheme along the lines of the successful national certification schemes in the United States and Canada. However, the UK scheme never gained traction, perhaps because it tried to cover too broad a field that included clinical engineering and rehabilitation engineering, perhaps because the profession at that time was diverse and did not coalesce around the scheme or perhaps because of the higher profile and status of the generic Charter Engineer run through the Engineering Council. Whatever the reasons, by 1998 the attempt to introduce a Clinical Engineering Certification was abandoned. In the UK, the Engineering Council is charged with maintaining the register of professional engineers who are referred to as chartered engineers (CEng) and use the designator letters CEng. IPEM holds a license to assess CEng candidates for registration under the auspices of the Engineering Council. This also extends to EngTech and incorporated engineer (IEng) candidates.
State registration The Health and Care Professions Council (HCPC) is the UK regulator with responsibility for maintaining the registered of healthcare professionals who meet defined standards for their training, professional skills, behavior, and health. The HCPC replaced the Council for Professions Supplementary to Medicine (CPSM) in 2002 and currently regulates 16 professions (it does not regulate doctors, dentists, or nurses). In 2000, the profession of Clinical Scientist was formally included in this register under the Professions Supplementary to Medicines act of 1960. The term clinical scientists (which is a protected title and can only be used by professionals on the registered) is a broad group of professions and includes clinical engineers. The primary aim of the HCPC is to protect the public by ensuring that professionals, including clinical engineers, achieve and maintain appropriate standards for their training, professional skills, behavior, and health. All clinical scientists, including clinical engineers, working in the UK health service must be registered. Loss of registration means that person may no longer work in the public sector.
The register of clinical technologists (RCT) The RCT was formed in 2000 (as the Voluntary Register of Clinical Technologists) with the aim of protecting the public by advocating statutory, professional regulation for clinical technologists. However, a new approach to regulation, namely accredited registers, has been established by the UK government in preference to statutory registers and in 2012 the Health and Social Care Act extended the role of the Professional Standards Authority (PSA) to include accrediting registers of people working in health and care occupations not regulated by statute.
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The RCT has been accredited by the PSA under its Accredited Registers program since September 2015. In order to obtain accreditation, an organization must show they have met the PSA’s specific, demanding standards relating to governance, standards for registrants (including education and training), and management of the register, by way of a rigorous application process. Organizations are then reaccredited each year provided they can show they are still meeting the PSA standards.
Conclusion Clinical engineering in the UK has matured as a profession from its early days supporting academic research to being an essential service supporting healthcare provision right across the NHS. Early achievements in biomedical research, adoption of quality-based service delivery, recognition of national training schemes, and state registration have all helped to confirm the sense of identity and gain professional acceptance in the UK healthcare market. However, UK clinical engineering cannot rest on its laurels. It needs
to continue to raise its profile, to continue to develop its services and to continue to support the changing and increasing demands of an ever more technology-dependent healthcare system.
References DB 2005(03), 2005. Guidance on the Safe and Effective Use of Batteries and Chargers for Medical Devices. IPEM,WebPage:https://www.ipem.ac.uk/AboutIPEM/GovernanceofIPEM/ History.aspx. Landoll, J.R., Caceres, C.A., 1969. Automation of data acquisition in patient testing. Proc. IEEE 57 (11), 1941–1953. Managing Medical Devices, 2006. Guidance for Healthcare and Social Services Organisations DB 2006(05). Managing Medical Devices, 2014. Guidance for Healthcare and Social Services Organisations. MHRA,https://www.gov.uk/government/organisations/medicines-andhealthcare-products-regulatory-agency. NHS Health Education England, 2018. Careers in Healthcare Science, NHSCB09. Regulation (EU) 2017/745 of the European Parliament and of the Council.
Clinical engineering in the United Kingdom Daniel Clark Clinical Engineering, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom; Faculty of Engineering, University of Nottingham, Nottingham, United Kingdom
Introduction Modern health care is ever more dominated by technology: technology has a role in hospitals and in community settings; in acute episodes and chronic care; and indeed, technology can be used to prevent people becoming unwell in the first place and help us all live longer and healthier lives. New technologies have the potential to revolutionize the way we manage health and well-being now and in the future. Research and development into new healthcare technology; the application of this technology in clinical settings and managing it to ensure it continues to work safely and effectively once deployed, requires the skills and experience of clinical engineers. The profession has grown from early days supporting pioneering research to being a vital resource supporting most healthcare provision in the UK. Despite this success, clinical engineering teams remain largely unsung heroes and need to continue to progress the profession’s profile and gain further recognition for its value to health care.
What is in a name? Well, that which we call a rose, by any other word might smell as sweet but a profession finds it hard to define its identity and raise its profile when it cannot agree on its own name. Over the years many terms have been used in the UK to describe the functions of the application of engineering to health and well-being: bioengineering, biomedical engineering, clinical engineering, medical equipment management (MES), electro-biomedical engineering (EBME), medical equipment servicing units (MESU), rehabilitation engineering, clinical instrumentation, biomechanics, and medical engineering amongst many others. The debate has not so much raged as bubbled along but today in the UK there is relatively broad agreement that two terms encompass the field: Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00007-9 Copyright © 2020 Elsevier Inc. All rights reserved.
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Biomedical engineering. The overarching term for engineers who use traditional engineering expertise to analyze and solve problems in biology and medicine, provides an overall enhancement in health care. It encompasses a range of subspecialties including biomechanics (including prosthetic devices and artificial organs); bioinstrumentation (including imaging system, sensors, and monitoring systems); biomaterials (including tissue engineering and regenerative medicine); systems physiology and physiological modeling. Clinical engineering. A separate but linked discipline, sometimes seen as a subspecialty of biomedical engineering, with a direct focus on the adoption, application, and management of healthcare technology in the clinical environment (and in the UK, predominantly in the hospital setting).
Of course, there is a dependency between and across these areas and even a degree of overlap. Moreover, the nature of these rapidly evolving fields makes definitions difficult but these two broad terms help describe the disciplines. And old habits, of course, die hard: the terms EBME, MESU, and others will still be heard in many hospitals across the UK. In general, biomedical engineering tends to the work at the more research and development end of the product lifecycle; clinical engineering at the more adopt, implement, and improve end. In general, biomedical engineers tend to work in academia, research facilities, and industry; clinical engineers in hospitals and other healthcare settings. But in all cases, engineering principles, good communications, multidisciplinary working, and a desire to improve the health and well-being of people is common. This chapter concentrates on clinical engineering in the UK and covers the early development of the field; the organization and management of clinical engineering services and the current range of services provided within the National Health Service (NHS); the standards and regulations in place covering clinical engineering services and the workforce delivering these services, their training and registration. 63
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Early years The application of technology to health care is not new. One of the earliest examples of medical device technology is a prosthetic toe that dates from about 1000 BCE (Before Common Era) and is currently on display in the Cairo Museum in Egypt. It is made from cartonnage, a sort of papier maché made using linen, glue, and plaster and demonstrates the engineering ingenuity of the time, though the Egyptians probably did not refer to the creator as a clinical engineer. Indeed, the first reported use of the term was not until much more recent times when cardiologist Cesar Caceres first coined the term (Landoll and Caceres, 1969) in 1969. A decade earlier, in 1959, a group of engineers, physicists, and physicians met at the Second International Conference of Medical and Biological Engineering, in the United Nations Educational, Scientific and Cultural Organization (UNESCO) Building, Paris to create an organization then entitled the International Federation for Medical Electronics and Biological Engineering (IFMBE). At that time there were few national biomedical engineering societies, and certainly not one for the UK, so individual workers in the discipline joined as Associates of the Federation. Later, as national societies were formed, these societies became affiliates of the Federation. The following year, the conference was held in London and served as the catalyst for the formation of a society to serve the needs of biomedical engineers in the UK and the biological engineering society (BES) was established in 1960. The name of the society reflected the aim of representing the widest possible group of multidisciplinary professionals working in the application of engineering to biological systems. In 1963, the BES was one of the first national societies to affiliate with the IFMBE and provided a focus for biomedical engineering activity in the UK. In 1995 the BES merged with the Hospital Physicists’ Association (HPA) to form what is now the Institute of Physics and Engineering in Medicine (IPEM) to create a single professional body representing the interests of physicists and engineers in medicine. In part this merger was a pragmatic marriage creating a larger and more resilient new institution to better support its professions; in part it reflected a general coming together of these teams at local level in hospitals across the NHS; but mostly this was an opportunity to integrate education, training, research, and methods of service delivery. The first hospital-based departments dedicated to engineering started to appear in the early 1970s. Before that, engineers employed in healthcare applications tended to be based in academic research facilities; within clinical departments in support of specific research programs or within medical physics departments in larger hospitals. The UK developed significant research strengths in biomedical engineering during this time developing many healthcare technologies in worldwide use today. Specific examples of these pioneers of biomedical engineering include (IPEM, n.d.): Sir Godfrey Hounsfield:
an electrical engineer who was awarded the Nobel Prize for developing X-ray computed tomography (CT) scanning; Sir Peter Mansfield: this Nobel Prize winner played a pivotal role in the development of the medical imaging using magnetic resonance imaging (MRI) and functional MRI; Professor Peter Wells CBE (Commander of the Order of the British Empire): awarded the Royal Medal in 2013, also known as the Queen’s Medal, for his pioneering work in medical ultrasound.
Organization of services and management arrangements During the same period there was an increasing dependency on medical equipment in healthcare provision and by the late 1960s and early 1970s, hospitals were becoming aware of the need to manage this equipment. Responsibility for medical equipment generally rested with the local Hospital Engineering Department (which would now be called the Estates Department) but there was the recognition that these teams—who managed fixed plant and nonmedical equipment—had neither the systems nor capacity to address the growing issue. Significant debate followed as to the best way to address the issue with two schools of thought prevailing: (1) that Hospital Engineering Departments should continue to manage all equipment, including medical equipment, and should be expanded and developed to facilitate this and (2) that biomedical engineers (including the newly termed Clinical Engineers) should establish new teams within existing Medical Physics Departments. In general, the larger hospitals that already had bioengineering activity usually based around research tended to develop services within Medical Physics Departments whereas the smaller hospitals tended to develop services within existing hospital engineers (estates) departments. This division is still apparent today with some hospitals, generally the major teaching hospitals, running engineering or scientifically led services usually out of medical physics and clinical engineering departments while the majority, generally smaller district general hospitals provide technically led services managed through estates departments.
Clinical engineering services in the UK Over the years, the development of different management arrangements in different hospitals led to a range of service provisions across the NHS: it is probably true to say that no two hospitals provide exactly the same services. It is therefore convenient to describe UK-based clinical engineering services initially in high-level terms. Fig. 1 describes the elements that a healthcare provider (hospital) should have in place to safely and effectively manage healthcare technology. This can be broadly grouped into three themes: healthcare technology management; healthcare technology innovation; and healthcare technology applications all of which require systems of governance to ensure patient safety.
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FIG. 1 Range of clinical engineering services.
Healthcare technology governance The paramount responsibility of the clinical engineering service is to ensure good governance of technology, ensuring the organization is compliant with national regulations and standards, and ultimately that patients are kept safe. The exact mechanism through which this is delivered will vary depending on the size of the hospital and the clinical engineering service but will include systems to respond to external and internal safety alerts; services to support investigations into clinical incidents involving medical devices; system to monitor, review interpret and implement relevant legislation, regulations, standards, and best practice guidance and support for corporate, hospital-wide groups developing healthcare technology strategy and policy.
Healthcare technology management Modern health care is hugely dependent on the availability and management of the medical equipment which is, perhaps, the core function of clinical engineers. Clinical engineers will be influential in, and indeed sometimes responsible for, medical equipment resourcing: managing, or being involved in, the acquisition of new medical equipment; ensuring the needs of the patients are met; ensuring that the equipment is appropriately evaluated before
a cquisition; ensuring that equipment is compliant to appropriate legal and regulatory standards and that when delivered to site that the equipment is safe and working correctly before it is used on patients. Increasingly, clinical engineers will also manage the availability of equipment through central stores or libraries, ensuring the right equipment is available at the right time and in the right condition. Medical equipment servicing ensures that the essential performance and safety of the equipment is maintained over its lifetime helping to support optimum clinical care for patients. Clinical engineering servicing teams maintain most medical equipment and place contracts with external servicing agents where appropriate. Servicing tasks will include acceptance checks to ensure equipment is safe and working correctly when first delivered, preventative maintenance to ensure equipment continues to perform as the manufacturer intended and repairs. Often, servicing teams are grouped by equipment portfolio which, depending on the size and nature of the hospital might include: general medical equipment; theaters and anesthetics, renal; critical care; radiotherapy and radiology. A key element to healthcare technology management is maintaining and developing records. Good inventory management is not only essential to manage the current equipment base but provides valuable insight for
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replacement programs and financial management of vital hospital assets. Most clinical engineering departments use one of a number of commercially available inventory systems (databases) but, unfortunately, there is a lack of consistency and standardization as to how these inventories are used leading to difficulties in national reporting and benchmarking.
Healthcare technology innovation While genuine ‘blue sky’ research (like that of Hounsfield, Mansfield, and Wells) is rare within NHS clinical engineering services these days, Clinical Engineers nonetheless make significant contributions to medical technology innovations in various ways. Some departments still run engineering and instrumentation groups that provide a bespoke technical solution to clinical research projects. Operational pressures and finances have made these services hard to sustain. The 2017 changes to the medical devices regulations (MDR2017/745, Regulation (EU) 2017/745 of the European Parliament and of the Council, n.d.) in Europe might, perhaps counterintuitively, present an opportunity for these services because well run NHS clinical engineering teams designing devices or elements of devices under appropriate quality systems will become more attractive to NHS clinical research projects than outsourcing to commercial or academic partners. While the number of centers designing and developing new devices is small, most departments will be facilitating clinical research by supporting the introduction of new and novel technologies as part of clinical research projects. Health technology assessment (HTA) is a developing role for clinical engineers. Traditionally, clinical engineers have not been active in this relatively new discipline but increasingly their skills and experiences are being recognized as valuable in this area. Moreover, as the focus of healthcare systems becomes more and more centered on financial sustainability, the role of new technologies to support more cost-effective health care is being highlighted. Clinical engineers, with their knowledge of technology, their systems-based methods, and their analytical skills are being seen more and more as key workers in this developing field.
Healthcare technology applications Clinical engineers play both a direct and indirect role in the applications of healthcare technology. Directly, some clinical engineers will be routinely supporting clinical services by providing technical and scientific input into clinics and procedures. This often overlaps with what is traditionally referred to in the UK as physiological measurement and includes services such as audiology, ophthalmology, electro-
diagnostics, clinical neurophysiology, human performance (gait analysis), and critical care technology. In some hospitals, these technical and scientific services are provided by staff employed directly with the clinical team, in others by staff in dedicated teams within medical physics services and in some centers by clinical engineering teams. Howsoever this service is provided, the staff tend to be based locally within the clinical areas and work directly with clinical staff and patients. Another area of direct clinical support that can involve clinical engineers is nonionizing radiation. It is perhaps more common in the UK for these services—which include lasers, microwaves, ultrasound, ultraviolet, thermometry, and diathermy— to be provided by the radiation physics teams. More generally, whenever new technology is introduced into the healthcare system, clinical engineering teams are involved in supporting clinical teams and ensure they optimize its performance. This can take the form of assessing the technology and working with the clinical teams to get the configurations correct, through to helping redesign the clinical pathway to account for the new technologies capabilities. Ordinarily, once the clinical service is established, the clinical engineer reduces or ends their involvement and the routine service is provided by the clinical teams.
Rehabilitation engineering A specific mention needs to be made to rehabilitation engineering. Sometimes this service is provided by the clinical engineering team but more often this is a standalone department, usually based with the multidisciplinary rehabilitation team that also includes physiotherapists, occupational therapist, speech and language therapist, and mobility teams. Rehabilitation engineers have very similar training and skills to clinical engineers but dedicate their service toward assessing and responding to the needs of people with disabilities. They provide standard and customer-made assistive technology including specialist seating; wheelchairs; artificial limbs; electronic communicators; and robotic aids. Indirectly, clinical engineers support the application of technology by providing medical devices training and competency management which can range from fairly small training and assessment centers on a limited number of medical devices through to full proficiency management covering most equipment used in the hospital across all staff groups. Increasingly, the NHS inspection bodies (see below) are looking for evidence that clinical staff are competent to use the equipment in their areas. Clinical engineers, with their extensive experience of equipment types, are well placed to manage systems to train and assess competency.
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Managing standards, regulations, and performance Regulations At time of writing, the UK medical devices market was regulated, in common with the rest of Europe, under three principle Directives: the Medical Devices Directive (EC 93/42/ EEC); the Active Implantable Medical Devices Directive (EC 90/385/EEC), and the In-Vitro Diagnostic Medical Devices Directive (EC 98/79/EC). The UK Competent Authority—the Medicines and Healthcare products Regulatory Agency (MHRA)—acts as the regulator for the medical devices industry. The MHRA ensures that manufacturers meet UK legislation (MHRA, n.d.) by monitoring incidents, approving of clinical trials and clinical investigations, auditing of UK notified bodies, maintaining the register of manufacturers of class I medical devices, and taking compliance and enforcement action where necessary. The MHRA also produce guidance intended primarily for people working in hospitals and community-based organizations that are responsible for the management of reusable medical devices, to help them set up and develop systems that promote the use of the medical devices for safe and effective health care (Managing Medical Devices, 2014). This guidance document (and its predecessors, Managing Medical Devices, 2006; DB 2005(03), 2005) form the basis of all clinical engineering services in the UK, outlining the principles, systems, and practices required for safe and effective management of medical devices. This guidance also influences the inspection bodies in the UK with respect to medical devices management. Changes to the European legislative framework for medical devices are being implemented with the current three Directives becoming two new Regulations: Regulation on Medical Devices (EU 2017/745) and Regulation on In vitro Diagnostic Medical Devices (EU 2017/746) with transition periods of 3 years (until 2020) and 5 years (until 2022), respectively. Clinical engineering departments are likely to have to adapt their services to meet these newer requirements but again, guidance from the MHRA is expected. Additionally, of course, at the time of writing, the UK is planning to leave the European Union and as such the legislative framework is now uncertain. The expectation is that the UK will continue to follow the EU regulations under a mutual recognition agreement but the future here is still unclear.
UK (NHS) healthcare inspection regimes The vast majority of health, well-being, and social care services provided to people in the UK is delivered by the NHS. A single system is in place across England and Wales, with slightly different approaches in Scotland and Northern
Ireland, but all essential an NHS provision. Additionally, there are a few smaller private and charity-based providers. All these services are subject to a single regulatory system and the principal regulatory body for all health service providers is the Care Quality Commission (CQC), an independent regulator of health and adult social care. The CQC make sure that health and social care services provide people with safe, effective, compassionate, high-quality care, and support care services to improve. They register care providers (a care provider must be registered in order to provide its services); inspect and rate services (Outstanding, Good, Requires Improvement, or Inadequate); take action to protect people (by issuing improvement notices for care providers where required or even by removing their right to provide services), and publish their findings. There is no national body with specific responsibility for inspection or regulation of clinical engineering services. Rather, these services are assessed, by the CQC, in terms of the support they provide to the clinical teams they serve. The CQC use available standards and best practice guidance when inspecting; in the case of clinical engineering, this tends to be the guidance produced by the MHRA (Managing Medical Devices, 2014). Although clinical engineering services are only a tiny fraction of everything that the CQC has to inspect, they tend to get a higher profile than their size might suggest because almost every patient episode will involve one or more medical device which can lead the inspector to ask questions about the clinical engineering teams. From April 2016 a second inspection body also took effect across the UK healthcare system. NHS Improvement (NHSi) is responsible for overseeing NHS organizations and offers the support these providers need to give patients consistently safe, high quality, compassionate care within local health systems that are financially sustainable. By holding providers to account and, where necessary, intervening, NHSi help the NHS to meet its short-term challenges and secure its future. While not strictly a regulator and without the powers to stop organizations from providing care services, they nonetheless hold significant influence over funding and their inspections, therefore, carry great weight. Like the CQC, NHSi does not specifically inspect clinical engineering services but again, because the impact of our services is so wide across all clinical teams, our roles can have a disproportionately large effect on any inspection.
Quality systems It is increasingly common for UK clinical engineering departments to operate within a quality management systems (QMS) with ISO 9001 being the primary standard. The quality management establishes the framework for how a service manages its key processes and helps ensure processes meet recognized standards, clarifying objectives and avoiding damaging and expensive mistakes. In the absence
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of a national inspection body for clinical engineering services, operating a QMS also enables departments to demonstrate their adherence to MHRA and other relevant guidance when inspected by the more generic CQC or NHSi inspectorate. Departments that manufacturer devices (which are relatively rare in the NHS) or are active in supporting design and development of medical devices also tend to be covered by ISO 13484.
Benchmarking Benchmarking can be an important part of performance management enabling different services to compare their processes and performance metrics to industry bests and to best practices from other departments. The diverse range and size of clinical engineering departments in the UK can make this challenging but the NHS National Performance Advisory Group (NPAG) support a number of benchmarking activities across many clinical engineering departments. This is not a requirement under any national regulatory or directive but supports best practice and service improvement.
Workforce Career and training pathways Clinical engineering comes under the umbrella term of healthcare science within the NHS. A career and training pathway for healthcare science is managed nationally through NHS Health Education England. Fig. 2 below shows the stages of this pathway generalized for all healthcare science professions (NHS Health Education England, 2018). The intention is that individuals can enter at one of three points as indicated on the diagram (dependent on academic qualification and experience) but can also travel up through the pathway supported by workplace and academic training programs. In theory, an individual can enter at the lowest point on the diagram and work themselves up to consult level. At the “Entry” Level, an individual might come directly from school or college or be appointed into a clinical engineering team from another career but without relevant qualifications or experience. Staff at this point would generally be referred to as Assistant Clinical Technologists or Associate Clinical Technologists. Their roles would vary depending on the department size and scope of service but might include a technical support function; basic user and technical maintenance; general workshop support roles. Clinical engineering assistants work toward vocational qualifications, often apprenticeships are used as a training route. They might also be trained through a higher-level apprenticeship, foundation degree or diploma. A national learning and development framework is being developed by Health Education England. Once implemented, the modular framework will provide a national learning structure for
assistants and associates with vocational awards and qualifications. However, this is not yet available for clinical engineering assistants and Associates. At the “Direct entry” level, an individual might come via progression from the clinical engineering assistant or associate route or might come directly from college with appropriate qualifications. Individuals might also be appointed from other careers provided they have relevant experience. Generically, this stage of the career pathway is termed the healthcare science practitioner, but within clinical engineering they are generally referred to as Clinical Engineering Technologists [or sometimes Clinical Engineering Technicians (EngTech)]. Healthcare science practitioners are now trained through NHS approved and accredited BSc honors degrees through the Practitioner Training Program (PTP) in various themes of healthcare science. Offered by a number of universities across England, the programs include academic learning and work-based training. The 50+ week work-based training element, supported by curricula, is spread over 3 years, involving broad scientific training in the first 2 years with an increasing focus on a chosen specialism during year 3. The PTP scheme is still maturing and is not generally well adopted within clinical engineering services. At the “Graduate direct entry” level, an individual usually comes post-university degree and would join the Scientist Training Program (STP). This is a 3-year program of work-based learning, underpinned by a university accredited master’s degree. Trainees are employed by an NHS hospital for the duration of the program and will be required to spend time in a range of settings, before specializing in the last 2 years of the program. Within clinical engineering, these specialisms cover Device Risk Management and Governance; Clinical Measurement; Design and Development; and Rehabilitation Engineering. The STP national recruitment process is managed by the National School of Healthcare Science. Generically, this stage of the career pathway is termed the trainee clinical scientist, but within clinical engineering they are generally referred to as trainee clinical engineers. Upon successful completion of the STP staff would become clinical engineers and be expected to join the nation register (see state registration below). Beyond this level, a further national training scheme is also available: the Higher Specialist Scientific Training (HSST). This is a 5-year program available to registered and experienced clinical scientists (including clinical engineers) who wish to train and become eligible to apply for consultant clinical scientist (including clinical engineer) posts. The program is equivalent to the standards of training undertaken by medical postgraduate trainees. Staff can join the program either as a direct entry (apply for a new post) or as an in-service entry (nominated by their current employer).
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Clinical academic career
Consultant clinical scientist
Higher Specialist Scientist Training (HSST)
Graduate direct entry Scientist Training Programme (STP) MSc Clinical science and work based programme
Statutory regulation (clinical scientist)
Clinical scientist Accredited Expert Scientific Practice
Potential equivalence and progression route
Direct entry Practitioner Training Programme (PTP) integrated BSC (Hons) Healthcare Science and statutory regulation
Biomedical scientist or accredited voluntary registration
Accredited Specialist Scientific Practice
Healthcare science practitioner
Potential equivalence and progression route
Entry Learning and development framework
Accredited voluntary registration
You can enter healthcare science at any of these levels
Healthcare science associates and assistants
Accredited Additional Scientific Practice
Source: www.dh.gov.uk
FIG. 2 Healthcare science career and training pathway.
Profile The number of staff and the roles they undertake will vary widely across clinical engineering departments depending on their size, the type, and size of the hospital they support, and the range of services they are involved with. The following is therefore merely indicative of what a typical department might look like, should such a thing exist.
Clinical engineers Generally, few in numbers—many departments will have one or two engineers and even larger departments rarely have more than 10—clinical engineers will work across all aspects of clinical engineering services. They provide support and leadership roles for most clinical engineering activities, being responsible for service delivery, practice,
and policy. They often have hospital-wide responsibility for medical devices governance and patient safety. Additionally, they often play lead roles in healthcare technology innovation, either directly through their own research or by facilitating technology-led research programs in hospitals.
Clinical engineering technologists The largest staff group, clinical engineering technologists are generally the mainstay of a clinical engineering department, predominantly working in the healthcare technology management field, and in servicing workshops, in particular. Some staff technologists, of course, will also be involved with the application of technology—particularly in clinical support roles—and others will support research and innovation activities.
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Assistant clinical engineering technologist Often seen as an entry-level role or apprenticeship, assistant technologists are an increasing staff group with clinical engineering services. Most departments try to have a small number of these roles to help future workforce requirements. However, assistant technologists provide a very useful role in themselves, often supporting the servicing functions of the department.
Equipment library staff Staff supporting equipment library functions in hospitals can be porters, assistant technologists, and supervisors. This very operational role not only involves the logistics side of ensuring equipment provision across the hospital but usually also includes basic user and technical servicing elements, particularly equipment cleaning, inspection, and battery management.
Nurses Clinical engineering services often provide training and competency management support for clinical users of medical equipment. This role might be delivered by engineers, technologists or nurses. Nurses bring clinical credibility and understanding to the role and when supported by a technical department can often enhance the service quality considerably.
Administration By the nature of their activities, clinical engineering departments have a significant need for good administration systems and business support staff. Often, this team is the essential glue that holds services together providing financial support, procurement, stock management, and record-keeping.
Health technology assessment analysts A growing role for clinical engineering HTA is making an increasing impact on health technology provision. Specialist HTA analysts remain rare in UK clinical engineering services but are likely to increase in the future.
Managers Most clinical engineering services are managed by clinical engineers or clinical engineering technologists. It is rare that a department would have a dedicated, nontechnical manager. However, larger departments often employ business managers to help with the increasing financial and contractual arrangements.
Clinical engineering certification There is no Clinical Engineering Certification scheme currently in operation in the UK. For a period in the 1980s and
1990s, attempts were made to introduce a scheme along the lines of the successful national certification schemes in the United States and Canada. However, the UK scheme never gained traction, perhaps because it tried to cover too broad a field that included clinical engineering and rehabilitation engineering, perhaps because the profession at that time was diverse and did not coalesce around the scheme or perhaps because of the higher profile and status of the generic Charter Engineer run through the Engineering Council. Whatever the reasons, by 1998 the attempt to introduce a Clinical Engineering Certification was abandoned. In the UK, the Engineering Council is charged with maintaining the register of professional engineers who are referred to as chartered engineers (CEng) and use the designator letters CEng. IPEM holds a license to assess CEng candidates for registration under the auspices of the Engineering Council. This also extends to EngTech and incorporated engineer (IEng) candidates.
State registration The Health and Care Professions Council (HCPC) is the UK regulator with responsibility for maintaining the registered of healthcare professionals who meet defined standards for their training, professional skills, behavior, and health. The HCPC replaced the Council for Professions Supplementary to Medicine (CPSM) in 2002 and currently regulates 16 professions (it does not regulate doctors, dentists, or nurses). In 2000, the profession of Clinical Scientist was formally included in this register under the Professions Supplementary to Medicines act of 1960. The term clinical scientists (which is a protected title and can only be used by professionals on the registered) is a broad group of professions and includes clinical engineers. The primary aim of the HCPC is to protect the public by ensuring that professionals, including clinical engineers, achieve and maintain appropriate standards for their training, professional skills, behavior, and health. All clinical scientists, including clinical engineers, working in the UK health service must be registered. Loss of registration means that person may no longer work in the public sector.
The register of clinical technologists (RCT) The RCT was formed in 2000 (as the Voluntary Register of Clinical Technologists) with the aim of protecting the public by advocating statutory, professional regulation for clinical technologists. However, a new approach to regulation, namely accredited registers, has been established by the UK government in preference to statutory registers and in 2012 the Health and Social Care Act extended the role of the Professional Standards Authority (PSA) to include accrediting registers of people working in health and care occupations not regulated by statute.
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The RCT has been accredited by the PSA under its Accredited Registers program since September 2015. In order to obtain accreditation, an organization must show they have met the PSA’s specific, demanding standards relating to governance, standards for registrants (including education and training), and management of the register, by way of a rigorous application process. Organizations are then reaccredited each year provided they can show they are still meeting the PSA standards.
Conclusion Clinical engineering in the UK has matured as a profession from its early days supporting academic research to being an essential service supporting healthcare provision right across the NHS. Early achievements in biomedical research, adoption of quality-based service delivery, recognition of national training schemes, and state registration have all helped to confirm the sense of identity and gain professional acceptance in the UK healthcare market. However, UK clinical engineering cannot rest on its laurels. It needs
to continue to raise its profile, to continue to develop its services and to continue to support the changing and increasing demands of an ever more technology-dependent healthcare system.
References DB 2005(03), 2005. Guidance on the Safe and Effective Use of Batteries and Chargers for Medical Devices. IPEM,WebPage:https://www.ipem.ac.uk/AboutIPEM/GovernanceofIPEM/ History.aspx. Landoll, J.R., Caceres, C.A., 1969. Automation of data acquisition in patient testing. Proc. IEEE 57 (11), 1941–1953. Managing Medical Devices, 2006. Guidance for Healthcare and Social Services Organisations DB 2006(05). Managing Medical Devices, 2014. Guidance for Healthcare and Social Services Organisations. MHRA,https://www.gov.uk/government/organisations/medicines-andhealthcare-products-regulatory-agency. NHS Health Education England, 2018. Careers in Healthcare Science, NHSCB09. Regulation (EU) 2017/745 of the European Parliament and of the Council.