Members
Chair : Prof.John Sandham
1.Iain Threlkeld
2.Martin Smith
3.Janet Leeson
4.Andrew Wagstaff
5.Caroline Finlay
6.Andrew Frost
1.1 Regulated Activities
The Health and Social Care Act 2008 (Regulated Activities) requires that medical equipment used in health and social care services is safe, suitable, and used correctly:
- Safety: Equipment must be safe for use and used safely.
- Suitability: Equipment must be suitable for its intended purpose.
- Correct use: Equipment must be used in accordance with the manufacturer’s technical specifications and guidance.
- Availability: There must be enough equipment to meet the needs of service users and ensure their safety.
- Comfort and independence: Equipment should promote the comfort and independence of service users.
- Maintenance: Equipment must be properly maintained.
- Cleanliness: Premises and equipment must be clean.
- Location: Premises and equipment must be appropriately located.
The Provision and Use of Work Equipment Regulations 1998 (PUWER) also apply to equipment in health and social care services. PUWER requires that equipment is: right for the job, used safely by trained people, and maintained so it remains safe.
Managing Medical Devices – Guidance for health and social care organisations
The purpose of this document is to outline a systematic approach to the acquisition, deployment, maintenance (preventive maintenance and performance assurance), repair and disposal of medical devices.
https://assets.publishing.service.gov.uk/media/6089dc938fa8f51b91f3d82f/Managing_medical_devices.pdf
CQC Regulation 15: Premises and equipment
The equipment that is used to deliver care and treatment is clean, suitable for the intended purpose, maintained, stored securely and used properly.
https://www.cqc.org.uk/guidance-providers/regulations/regulation-15-premises-equipment
Regulation 12: Safe care and treatment
https://www.cqc.org.uk/guidance-providers/regulations/regulation-12-safe-care-treatment
Providers must assess the risks to people’s health and safety during any care or treatment and make sure that staff have the qualifications, competence, skills and experience to keep people safe.
Responsible Director
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.
https://www.ebme.co.uk/articles/management/equipment-standards-guidance-and-legislation
