Response to UK Government Consultation on Statutory Healthcare Regulation
RESMAG supports and is lobbying for the statutory regulation of Rehabilitation Engineers and will be sending a response to the government consultation. Members are urged to respond to the consultation too. For information, we have provided here to members the text used which may of use to you if you decide to respond too.
RESMaG response to the Healthcare regulation: deciding when statutory regulation is appropriate – GOV.UK (www.gov.uk) DHSC open consultation (closing date 31.03.22)
For detailed consultation document, please see:
For submission of response via online form please see: Respond online
Do you agree or disagree that a qualitative and quantitative analysis of the risk of harm to patients is the most important factor to consider when deciding whether to regulate a health or care profession?
The purpose of regulation is to protect patients and the public from harm which may arise as a result of health or care professionals either not being competent to practice or not knowing the limits of their competence (or both).
Do you agree or disagree that proportionality, targeted regulation and consistency should also be considered in deciding whether to regulate a health or care profession?
Consistency is particularly important as the risk of harm may be well managed by one employer but poorly managed by another.
Do you agree or disagree that the currently regulated professions continue to satisfy the criteria for regulation and should remain subject to statutory regulation?
De-regulation would result in a reduction in standards and introduce inconsistency thereby increasing risk to patients and the public.
Do you agree or disagree that currently unregulated professions should remain unregulated and not subject to statutory regulation?
It is highly inconsistent that healthcare science practitioners/clinical technologists working in rehabilitation engineering, namely, as ‘rehabilitation engineers’, are not regulated while other professions whose interactions with patients present a similar (or lower) risk profile are regulated. For example, Clinical Scientists working in rehabilitation engineering have been regulated since the mid-2000s and, while the roles are different, the risk profiles are similar.
If you disagree, please provide any evidence in relation to the criteria outlined above that supports a proposal to include a currently unregulated profession within statutory regulation.
Regulation of healthcare science practitioners/clinical technologists working in rehabilitation engineering, namely, as ‘rehabilitation engineers’, is essential in order to protect patients/service users from the unacceptable level of risk of harm that arises from the current inherently inconsistent measures to protect patients/service users via voluntary registration given the huge variation in its implementation across (NHS, private and third sector) employers. ‘Rehabilitation engineers’ work directly with patients and, among other things, lead the prescription and provision of bespoke medical devices to meet clinical and functional needs for which they must be highly competent and demonstrate appropriate values and behaviours.
Rehabilitation Engineers work within healthcare institutions, commercial providers and the third sector providing assistive technologies. Many of the services are assistive technology services funded by NHS England, NHS Scotland, NHS Wales and Health and Social Care in Northern Ireland including Wheelchair and Special Seating services, Prosthetic and Orthotic services, Environmental Control systems and Augmentative and Alternative Communication services. The service specifications for these services require a multi-disciplinary team consisting of Clinical Scientists, Rehabilitation Physicians, Occupational Therapists, Speech and Language Therapists, Physiotherapists, Prosthetists, Orthotists, Psychologists, specialist education professionals (teachers) and Clinical Technologists/Rehabilitation Engineers. All of these professions require statutory registration EXCEPT the Clinical Technologists/ Rehabilitation Engineer even though the activities they typically carry out as specified within the service specification documents including design and manufacture of medical devices, planned preventative maintenance have an equivalent or higher risk profile than the activities performed by other members of the MDT (https://www.england.nhs.uk/wp-content/uploads/2018/08/complex-disability-equiptment-environmental-controls-all-ages.pdf, https://www.england.nhs.uk/commissioning/wp-content/uploads/sites/12/2016/03/aac-serv-spec-jan-2016.pdf, https://www.england.nhs.uk/wp-content/uploads/2017/07/wheelchairs-model-service-specification.pdf).
Rehabilitation Engineers are frequently required to work alone within Rehabilitation Centres and in the community to carry out activities such as clinical and technical assessment, designing, building and commissioning bespoke medical devices, performing repairs and modifications to medical devices, putting medical devices into service, performing planned preventative maintenance, adjusting and otherwise maintaining medical devices. This may be without direct supervision and requires robust training, skill development and competence. Statutory regulation would ensure this high level of competence is maintained in an area of activity with a high risk profile.
An understanding of quality, risk and regulatory compliance is a core part of Rehabilitation Engineering training and development. This reflects the higher risk profile of Rehabilitation Engineering activities.
The activities of Rehabilitation Engineers have a direct impact on Recommendation 2 (…seeks improvement to patient safety around the use of medical devices) and Recommendation 6 (MHRA needs substantial revision to adverse incident reporting) of The Independent Medicines and Medical Devices Safety Review (Cumberlege Report). As part of NHS service provision Rehabilitation Engineers are actively designing, specifying and manufacturing medical devices which have the potential to cause harm.
Anecdotally, Rehabilitation Engineers will be the member of the MDT who investigate safety critical incidents and report adverse incidents to the MHRA.
Rehabilitation Engineers contribute to the development of best practice, standards and the regulatory framework including medical device regulation.
Outside of healthcare institutions with often higher governance levels, the requirement for an employee to be voluntarily registered or to document competence is less common. Rehabilitation Engineers perform activities within these organisations who may not become members of trade associations and sign up for the governance of codes of conduct of these organisations. Statutory regulation of Rehabilitation Engineers, regardless of the type of organisation they work for, would ensure consistency and competence across all sectors reducing the risk to service users.