Managing Medical Devices. MHRA Guidance for health and social care organisations

In January, the MHRA published its updated guidance for managing medical devices in the UK. Below are key extracts:

1.1 Aims of the guidance

To outline a systematic approach to the acquisition, deployment, maintenance (preventive maintenance and performance assurance), repair and disposal of medical devices. It is intended primarily for people in hospital and community based organisations that are responsible for the management of 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

Where available, use a service provider or third-party repairer who complies with relevant quality system standards, such as European Standard BS EN ISO 13485: (2016)

Managing Medical Devices January 2021

8.2 Choosing appropriate maintenance and repair services

The healthcare organisation should carry out a risk-benefit analysis before finalising the specification of any maintenance and repair services. Cost alone should not be the determining factor. Where available, use a service provider or third-party repairer who complies with relevant quality system standards, such as European Standard BS EN ISO 13485: (2016) [18] or BS EN ISO 9001:(2015) [19]. These standards ensure their work is consistently of the nature and quality intended.

11 Legislation

This section gives examples of legislation that might apply to your organisation. It is not an exhaustive list.

• Consumer Protection Act 1987 (Consumer Safety and Product Liability) [13]
• Health and Safety at Work etc. Act (HASAWA) 1974 [12]
• Ionising Radiation (Medical Exposures) Regulations 2017 IR(ME)R
• Ionising Radiations Regulations 2017(IRR) [16]
• Management of Health and Safety at Work Regulations 1999
• Medical Devices Regulations 2002 (SI 2002 No 618, as amended) [5]
• Sale and Supply of Goods Act 1994 (Chapter 35) [29]
• The Common Law of Negligence: Law Reform (Contributory Negligence) Act
  1945 [15]
• The Control of Substances Hazardous to Health Regulations 2002
• The Electrical Equipment (Safety) Regulations 1994 [31]
• The Electricity at Work Regulations 1989 [11]
• The Employers’ Liability (Compulsory Insurance) Regulations 1998
• The General Product Safety Regulations 2005 [14]
• The Health and Social Care Act 2008 (Regulated Activities) Regulations 2010.
  Regulation 16 Safety, availability and suitability of equipment
• The Lifting Operations and Lifting Equipment Regulations 1998 [17]
• The Pressure Systems Safety Regulations 2000
• The Provision and Use of Work Equipment Regulations 1998
• The Waste Electrical and Electronic Equipment Regulations 2006 and The Waste
  Electrical and Electronic Equipment (Amendment) Regulations 2007 [23]
• Trade Descriptions Act 1968 [30]
• Unfair Contract Terms Act 1977 [32]

12.1 References

A non-exhaustive list of standards designated to the relevant legislation, including the UK MDR 2002, can be found here: https://www.gov.uk/guidance/designated-standards

1. Care Quality Commission. Essential standards of quality and safety. 2010
2. NHS England and MHRA. Improving medical device incident reporting and learning.
3. NHS Digital https://digital.nhs.uk/data-and-information/looking-after-information/datasecurity-and-information-governance/codes-of-practice-for-handling-information-inhealth-and-care/records-management-code-of-practice-for-health-and-social-care2016
4. MHRA. Devices in Practice
5. Medical Devices Regulations 2002 (SI 2002, No 618, as amended)
6. BS EN 62366-1:2015 Medical devices. Application of usability engineering to medical
   devices
7. BS EN 60601-1-8:2007+A11:2017, Medical electrical equipment. General
   requirements for basic safety and essential performance. Collateral Standard.
   General requirements, tests and guidance for alarm systems in medical electrical
   equipment and medical electrical systems. 2007

Key Takeaway

Whilst the updated guidance contains a lot of information, the key point is that the healthcare organisation should use a service provider or 3rd party repairer who complies with a quality system standard, such as EN ISO 13485: (2016).

About Bakare®

Bakare® is committed to delivering the best possible service and products to our customers, and our ISO 13485:2016 accreditation shows our commitment ensuring their satisfaction.

Bakare®’s ISO 13485:2016 accreditation means that our customers can be confident that the products & services we supply are safe and and of the highest-quality. It also means that we have the systems in place to catch and correct any issues before they become problems. ISO 13485:2016 sets the benchmark for quality and safety, and we are proud to meet and exceed these standards. This accreditation proves our dedication to delivering the best possible service and products to our customers, and our commitment to their satisfaction.