The Government has introduced new legislation into the Health and Social Care Act, bringing in the most wide-ranging reforms of the NHS since it was founded in 1948.
Health and Social Care Act (Regulated Activities) Regulations 2014: Regulation 15
The intention of this regulation is to make sure that the premises where care and treatment are delivered are clean, suitable for the intended purpose, maintained and where required, appropriately located, and that the equipment that is used to deliver care and treatment is clean, suitable for the intended purpose, maintained, stored securely and used properly. Providers retain legal responsibility under these regulations when they delegate responsibility through contracts or legal agreements to a third party, independent suppliers, professionals, supply chains or contractors. They must therefore make sure that they meet the regulation, as responsibility for any shortfall rests with the provider. Where the person using the service owns the equipment needed to deliver their care and treatment, or the provider does not provide it, the provider should make every effort to make sure that it is clean, safe and suitable for use. The CQC cannot prosecute for a breach of this regulation or any of its parts, but they can take regulatory action. The CQC must refuse registration if providers cannot satisfy them that they can and will continue to comply with ‘Regulation 15’.
Note: 'Premises' and 'equipment' are defined in the regulations. The definitions make sure that the term 'premises' does not apply to the person's own accommodation where accommodation is not provided as part of their care and treatment. In addition, 'equipment' does not include equipment at the person's own accommodation, where it is not provided as part of their care or treatment.
As part of these changes, it recognised there are problems with managing medical devices that pose a risk to patient safety and result in increasing costs, and therefore more stringent requirement were brought. These requirements were interpreted by the ‘Medicines and Healthcare Products Regulatory Agency (MHRA) which then produced guidance in January 2021 entitled ‘Managing Medical Devices - Guidance for healthcare and social services organisations’. (The role of the MHRA is to protect and promote public health and patient safety. One way it does this is by regulating medical devices in the UK – ensuring they comply with the Medical Devices Regulations).
The purpose of ‘Managing Medical Devices - Guidance for healthcare and social services organisations’ is to outline a systematic approach to the acquisition, deployment, maintenance (preventive maintenance and performance assurance), repair and disposal of medical devices.
The MHRA also gives guidance on medical device training. It is intended primarily for people in hospital and community based organisations 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. Many of the principles of this guidance document may apply to all medical devices. However, not all sections may apply to implantable devices, and in vitro diagnostic (IVD) medical devices are covered in separate documents.
Medical devices play a key role in healthcare, vital for diagnosis, therapy, monitoring, rehabilitation and care. Effective management of this important resource is required to satisfy high quality patient care, clinical and financial governance, including minimising risks of adverse events. Unless medical devices are managed proactively, the same types of adverse incidents happen repeatedly. Good medical device management will greatly assist in reducing their potential for harm.
This guidance document updates and replaces previous guidelines published in:
- Managing Medical Devices - Guidance for healthcare and social services organisations - April 2015
- Managing Medical Devices. Guidance for healthcare and social services organisations DB 2006(05) November 2006
- Guidance on the safe and effective use of batteries and chargers for medical devices DB 2005(03) October 2005
Care Quality Commission
To enforce these standards, the Care Quality Commission (CQC) also issued guidance around maintenance, user training, and decontamination. CQC inspections require evidence of reliable systems, processes and practices in place to keep people safe. This includes the use and maintenance of medical equipment, and ensuring that equipment is not out-of-date. CQC inspectors will regard out-of-date equipment with the same significance as out-of-date medicines.
As part of regulation 15, out-of-date equipment could include needles, syringes, and defibrillator pads. If these are out-of-date, they are unsafe. There is the potential they could be used to administer drugs to patients or used for venepuncture.
Healthcare organisations are responsible for ensuring their medical devices are maintained appropriately: this includes maintaining and repairing all medical devices correctly, including reconditioning and refurbishment. Maintenance and repair of medical devices forms part of risk assessment activity under the Health and Safety at Work Regulations 1999 (management regulations). The Health and Safety Executive publish comprehensive guidance on risk assessment.
As employers, we're required by law to protect our employees, and others, from harm. Under the Management of Health and Safety at Work Regulations 1999, the minimum you must do is:
- identify what could cause injury or illness in your business (hazards)
- decide how likely it is that someone could be harmed and how seriously (the risk)
- take action to eliminate the hazard, or if this isn't possible, control the risk
Assessing risk is just one part of the overall process used to control risks in your workplace.
Healthcare providers should have a system in place to ensure regular and appropriate inspection, calibration, maintenance and replacement of equipment. Individual manufacturer’s guidance should be followed regarding frequency of calibration and electrical testing. Inaccurate readings from faulty or poorly calibrated machines can impact on quality of care and treatment. For example errors in blood pressure determination could result in patients receiving treatment they do not need, or increasing their clinical risk if blood pressure is underestimated.
Staff responsibilities and training: Healthcare providers must ensure they;
- know which members of staff have responsibility for medical equipment
- the intervals between equipment inspections
- the system for reporting faults
- maintain records for all medical equipment used
Healthcare professionals should have received training to operate medical equipment. They have a responsibility to check the suitability of the equipment they are using and report any faulty equipment.
The core areas of management responsibility include procurement, user training, maintenance and management, as illustrated below.
Healthcare organisations should appoint a director or board member with overall responsibility for medical device management. There should be systems in place to ensure reporting of device issues including:
- the effectiveness of the medical devices management system
- the condition and performance of medical devices including: device failures and issues; utilisation, performance, maintenance; repair and calibration history
- the execution of investment, replacement and disposal plans.
The management structure for medical devices should have clear lines of accountability up to board level. These lines of accountability should be extended, where appropriate, to include general practitioners, residential and care homes, community based services, independent hospitals providing services for NHS patients, managed care providers, Private Finance Initiative (PFI) organisations and other independent contractors.
It is important to establish who is accountable, and where there is a need for joint accountability arrangements. Healthcare organisations should appoint Medical Device Safety Officers (MDSO) or equivalent. MDSOs replace Medical Device Liaison Officers. Part of the MDSO role is to report adverse incidents to the MHRA and other official agencies. The lines of accountability should include reference to the appointment of such safety officers. Healthcare organisations should set out a long term approach and objectives for the management of their medical devices, including strategic replacement and development equipment procurement planning. This should include an overarching medical devices management strategies setting out medium to long term organisational requirements of assets taking account of cost, performance and risk across the entire equipment lifecycle. This strategic approach should also align with the responsible organisations overarching business / strategic plan.
Dr John Sandham, 2023.