Health and Social Care Act 2008; Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
Health and Social Care Act 2008: regulated activity and equipment
The Health and Social Care Act 2008 created the Care Quality Commission and requires anyone carrying on a 'regulated activity' in England to be registered with it. Dental practices carry on regulated activities such as treatment of disease, disorder or injury, diagnostic and screening procedures and surgical procedures, so they must be registered and must meet the fundamental standards set out in the 2014 Regulations.
In plain English
The Health and Social Care Act 2008 created the Care Quality Commission and requires anyone carrying on a 'regulated activity' in England to be registered with it. Dental practices carry on regulated activities such as treatment of disease, disorder or injury, diagnostic and screening procedures and surgical procedures, so they must be registered and must meet the fundamental standards set out in the 2014 Regulations.
Registration attaches to the provider, not to the building or the equipment. Equipment matters because the fundamental standards (including Regulation 12 on safe care and treatment and Regulation 15 on premises and equipment) cannot be met if the equipment used to deliver the regulated activity is unsafe, unsuitable or unmaintained.
The Act itself says little about engineering. Its practical effect is that a registered provider must be able to show, on request, that the equipment used in regulated activity is fit for purpose and looked after.
Who does what
Your responsibility as the provider
- Being registered with the CQC for each regulated activity carried on, and at each location
- Meeting the fundamental standards in the 2014 Regulations, including those that touch equipment (Regulations 12, 15 and 17)
- Having a registered manager where required, and making sure equipment responsibilities are assigned to someone in the practice
- Notifying the CQC of the events the regulations require, which can include incidents involving equipment that cause harm
- Keeping the records needed to demonstrate all of the above
What Dynamo Dental delivers directly
Dynamo Dental supports the equipment part of this for chairs and treatment units, compressors, suction systems and amalgam separators. We help practices organise relevant maintenance records and identify next actions within the agreed scope. The practice remains responsible for ensuring its regulatory duties are met.
Within that scope we provide:
- Servicing, repair and installation carried out to the manufacturer's instructions
- Reports and an asset register that give a registered manager a clear view of what is maintained and when it is next due
- Plain statements of what was done, what was found and what we recommend
- Identification of maintenance gaps we notice during a visit or a Practice Engineering Survey
Verified specialist competence, or a specialist partner
- Registration, statements of purpose and CQC notifications are matters for the provider, usually with its own compliance adviser or professional body
- Clinical equipment outside our scope (decontamination, radiography, medical gases, fixed electrical installation) needs its own competent specialist
- Where an incident involving equipment must be reported (for example to the CQC or the MHRA), the decision and the report are the provider's; we supply the engineering facts
Outside our scope
- Applying for or maintaining CQC registration on a practice's behalf
- Acting as, or advising, the registered manager on regulatory questions
- Compliance audits or mock inspections
- Any statement that a practice is 'compliant' with the Act or the Regulations
Questions
Questions on this topic
Does Dynamo Dental need to be CQC registered to service our equipment?
No. Registration applies to providers carrying on regulated activities, such as treating patients. An engineering contractor servicing equipment is not carrying on a regulated activity. What matters is that the practice, as the registered provider, can show its equipment is maintained by people with appropriate competence and that the records exist.
Which of the fundamental standards mention equipment?
Regulation 12 (safe care and treatment) requires that equipment used for care or treatment is safe for that use and is used safely. Regulation 15 (premises and equipment) requires it to be suitable, properly used and properly maintained. Regulation 17 (good governance) requires accurate, complete and contemporaneous records, including those needed to manage the regulated activity. Check the CQC's current guidance for the full wording.
Other topics
- Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 15 (Premises and equipment)CQC Regulation 15: premises and equipment
- Provision and Use of Work Equipment Regulations 1998 (SI 1998/2306)PUWER 1998: Provision and Use of Work Equipment Regulations
- Pressure Systems Safety Regulations 2000 (SI 2000/128)PSSR 2000: Pressure Systems Safety Regulations and dental compressors
- Pressure Systems Safety Regulations 2000, Regulations 8 and 9 (written scheme of examination; examination in accordance with the written scheme)Written Schemes of Examination for dental compressors
- Electricity at Work Regulations 1989 (SI 1989/635)Electricity at Work Regulations 1989 and dental equipment
- Health Technical Memorandum 01-05: Decontamination in primary care dental practices (NHS England, 2013 edition)HTM 01-05: decontamination equipment and maintenance
Not sure what records you should have?
The Practice Engineering Survey establishes what exists and what is missing, without claiming to be an audit.
- 07915 527 907
- info@dynamodental.co.uk
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