Care Quality Commission Guidelines

Outcome 11: Safety, availability and suitability of equipment

What do the regulations say?

Safety, availability and suitability of equipment
16.—(1) The registered person must make suitable arrangements to protect service users and others who may be at risk from the use of unsafe equipment by ensuring that equipment provided for the purposes of the carrying on of a regulated activity is—
(a) properly maintained and suitable for its purpose; and
(b) used correctly
(2) The registered person must ensure that equipment is available in sufficient quantities in order to ensure the safety of service users and meet their assessed needs.
(3) Where equipment is provided to support service users in their day to day living, the registered person must ensure that, as far as reasonably practicable, such equipment promotes the independence and comfort of service users.
(4) For the purposes of this regulation
(a) “equipment” includes a medical device; and
(b) “medical device” has the same meaning as in the Medical Devices Regulations 2002.Source: Regulation 16 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010.

Outcome - What should people who use services experience?

People who use services and people who work in or visit the premises:
●● Are not at risk of harm from unsafe or unsuitable equipment (medical and non-medical equipment, furnishings or fittings)
●● Benefit from equipment that is comfortable and meets their needs

This is because providers who comply with the regulations will:
●● Make sure that equipment:
–– is suitable for its purpose
–– is available
–– is properly maintained
–– is used correctly and safely
–– promotes independence
–– is comfortable
●● Follow published guidance about how to use medical devices safely.

Prompts for all providers to consider

The following prompts relate to all registered providers unless otherwise stated. The term ‘equipment’ always includes ‘medical devices’.

Ensure equipment is adequate

11A People are safe because, where equipment is provided or used as part of the regulated activity, the equipment is:
●● Available in sufficient quantities to meet the needs of people who use the service
●● Safe to be used
●● Suitable for its stated purpose
●● Compliant with all relevant laws
●● Installed, used and maintained correctly with reference to the specifications, manufacturer’s instructions, legislation and appropriate guidance from expert bodies
●● Properly maintained, tested, serviced and renewed under a recorded programme
●● Stored safely and securely to prevent theft, damage or misuse

11B People’s needs are met because staff using any equipment do so in a way that has regard to their dignity, comfort and safety and promotes their independence by:
●● Actively listening to their preferences and thoughts about the equipment they need and how it is used.
●● Supporting the person to understand how and why the equipment is being used.
●● Taking care in the way they use the equipment to make sure the person is comfortable and safe.
●● Using the equipment in a way that ensures the person’s privacy and dignity.

Manage risk through effective procedures about equipment suitability

11C People are safe because, where equipment is provided as part of the regulated activity, there are clear procedures followed in practice, monitored and reviewed.
Wherever necessary these include:
●● Identification, assessment and review of risk.

●● Where risks are identified, a plan for how these are to be managed.
●● How the equipment is maintained and used.
●● Ensuring that all staff involved in using the equipment have the competency and skills needed, and where this is not possible, know what to do to ensure the people remain safe.
●● How staff will know what to do when a person who uses services refuses to allow use of the equipment.
●● The arrangements for adverse events, incidents, errors and near miss reporting. These should encourage local and, where applicable, national reporting, learning and promoting an open and fair culture of safety.
●● The training of people who use services about any equipment they are given to use themselves.
●● Best interest meetings with people who know and understand the person using the services to ensure that treatment and care are taken that reflect the person’s best interest.
●● What will happen in the event of electricity, water or gas supply failure, or other emergencies, that affect the equipment used to meet the needs of people who use services.

11D Where people who use services receive care, treatment or support that involves the use of medical devices, the provider has:
●● Clear procedures that are followed in practice, monitored and reviewed for the use of medical devices. Wherever they are required these procedures include:
–– implementing guidance issued by experts or professional bodies in relation to the medical devices used
–– acting on alerts from an expert or professional body or a product manufacturer.

11E People who use services receive care, treatment and support from a service that:
●● Takes into account relevant guidance, including that from the Care Quality Commission’s Schedule of Applicable Publications (see appendix B).

Providing personalised care through the effective use of medical devices

11F People who use services receive care, treatment and support that:
●● Ensures the medical devices used to meet their needs are:
–– not reused if they are manufactured for single use only
–– only modified in line with manufacturer’s instructions or guidance
–– only purchased if they meet the necessary legal requirements
–– available when they are required for use
–– supplied with the necessary technical information so that the risk of using them incorrectly is minimised
–– permanently installed where appropriate, in accordance with manufacturer’s requirements and published guidance
–– only used by the person, or by staff, once they know how to use and operate them correctly
–– monitored while being used and action taken if they do not appear to be working correctly
–– routinely maintained in line with the manufacturer’s instructions and by people who are competent to do so
–– repaired when they break down by people who are competent to do so
–– disposed of or recycled, safely and securely.

Additional prompts for specific service types

In addition to the prompts for all providers above, the following prompts relate to specific service types. Please refer to “Step 2: Select your service types” on page 13, to make sure that you identify which service types apply to you.

11G When equipment is used in a person’s own home:
●● Staff address any concerns in a timely manner where they have identified problems around the safety of the equipment.

11H People who use services receive care, treatment and support that:
●● Ensures equipment required for resuscitation or other medical emergencies is available and accessible for use as quickly as possible. Where the service requires it, this equipment is tamper proof.

Source: The Care Quality Commission (CQC) guidelines - ‘'Guidance about compliance: Essential standards of quality and safety'

© Care Quality Commission 2010

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