HTM 01-05 decontamination policy (dental)

1. What the regulation says

Care and treatment must be provided in a safe way for service users. (Reg 12(1) (the headline duty))

assessing the risks to the health and safety of service users of receiving the care or treatment, (Reg 12(2)(a) (risk assessment))

doing all that is reasonably practicable to mitigate any such risks, (Reg 12(2)(b) (risk mitigation))

ensuring that the premises used by the service provider are safe to use for their intended purpose and are used in a safe way, (Reg 12(2)(d) (premises safety))

ensuring that the equipment used by the service provider for providing care or treatment to a service user is safe for such use and is used in a safe way, (Reg 12(2)(e) (equipment safety))

assessing the risk of, and preventing, detecting and controlling the spread of, infections, including those that are health care associated, (Reg 12(2)(h) (infection control))

The full text of the regulation is at https://www.legislation.gov.uk/uksi/2014/2936/regulation/12. Where this policy and the regulation diverge, the regulation wins.

2. Plain-English summary

Care and treatment must be provided in a safe way. The regulation lists the areas a provider must address, including risk assessment, risk mitigation, staff competence, safe premises, safe equipment, sufficient equipment and medicines, medicines safety, infection prevention and shared-care planning. Regulation 12 is central to CQC's safety expectations.

3. Purpose

This policy sets out how the Practice decontaminates reusable dental instruments, records traceability, checks equipment and audits the process. It is written for primary-care dental services that use local decontamination arrangements.

This policy is a starting template. The Practice must verify the detail against the current Health Technical Memorandum 01-05 source before adoption.

4. Sources to verify before adoption

• NHS England, Health Technical Memorandum 01-05: Decontamination in primary care dental practices: https://www.england.nhs.uk/publication/decontamination-in-primary-care-dental-practices-htm-01-05/
• HTM 01-05 PDF, 2013 edition: https://www.england.nhs.uk/wp-content/uploads/2021/05/HTM_01-05_2013.pdf
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 12: https://www.legislation.gov.uk/uksi/2014/2936/regulation/12
• CQC dental guidance and current assessment material for infection prevention and control: https://www.cqc.org.uk/guidance-providers/dentists

5. Scope

This policy applies to:

• all reusable dental instruments used at the Practice
• all clinical staff who handle, transport, clean, inspect, sterilise, store or trace instruments
• the decontamination room, clean storage areas and any surgery-level transfer process
• validation, maintenance and testing of washer-disinfectors, ultrasonic cleaners and sterilisers where used

Single-use instruments are not reprocessed. Staff dispose of them according to the Practice waste policy.

6. Step-by-step decontamination procedure

The Practice follows a documented decontamination cycle for each reusable instrument batch.

6.1 Acquisition and intake

• The Practice buys instruments from approved suppliers and records the instrument type, batch or asset reference where available.
• The Practice checks new instruments before first use and records that they are suitable for the intended dental procedure.
• Damaged, corroded or unsuitable instruments are removed from use.

6.2 Transport from surgery to decontamination area

• Used instruments are moved in a designated lidded container.
• Staff keep used instruments separate from clean instruments at all times.
• Sharps are managed under the Practice sharps policy.

6.3 Cleaning

• Staff clean instruments using the Practice-approved process, such as washer-disinfector, ultrasonic cleaner or manual cleaning where permitted by the local procedure.
• Staff follow the equipment manufacturer's instructions and the current HTM 01-05 source for the chosen cleaning route.
• Staff record failed cleaning cycles and repeat the process before inspection.

6.4 Inspection

• Staff inspect instruments under adequate lighting before sterilisation.
• Any instrument that remains visibly contaminated, damaged or unsafe is removed from the clean flow.
• The staff member records rejected instruments and the action taken.

6.5 Sterilisation

• Staff sterilise instruments only in a validated steriliser.
• Staff select the cycle that matches the instrument and packaging status.
• Staff record the cycle reference, date, time, operator and any failed cycle.

6.6 Storage

• Staff store sterile or disinfected instruments in the designated clean area.
• Packaged instruments are stored according to the current HTM 01-05 source and local procedure.
• Staff do not use instruments where packaging is damaged, wet, unsealed or past the Practice's locally verified storage period.

6.7 Traceability

• The Practice keeps instrument traceability records that connect the instrument batch, sterilisation cycle and patient record where the Practice's process requires it.
• Traceability records are kept in the decontamination log or approved digital record.
• Where traceability cannot be confirmed, the Registered Manager reviews whether the instruments can be used.

6.8 Failed cycle, contamination or traceability gap

1. Stop release and separate the batch. Mark affected instruments as not for use and keep them outside the clean flow.
2. Record the failure. Capture the equipment, cycle or batch reference, time, operator, failed check and instruments affected.
3. Assess whether anything was already used. Identify any patient, surgery or procedure linked to the affected batch and obtain clinical and infection-prevention advice where required.
4. Identify and correct the cause. Check loading, cleaning, packaging, equipment, process and staff factors. Do not return faulty equipment to use without the required checks or competent advice.
5. Reprocess only when safe. Start the full approved cycle again where the instrument and manufacturer's instructions permit it, then record the successful release decision.
6. Escalate and learn. Open an incident for a used, lost or potentially contaminated batch, consider the risk register and track corrective action through governance.

7. Essential-quality and best-practice-quality position

HTM 01-05 distinguishes between essential-quality requirements and best-practice-quality improvements. The Practice records its current position against both levels.

• Essential quality: the Practice must meet the essential-quality decontamination standard before this policy is adopted.
• Best-practice quality: the Practice keeps a written improvement plan for any best-practice-quality element not yet in place.
• The Registered Manager reviews the position at least annually and after any equipment, premises or process change.

The Practice must verify the current wording and test requirements in HTM 01-05 before adopting this section.

8. Autoclave validation and equipment checks

The Practice keeps an equipment file for each steriliser. The file includes:

• asset number and location
• manufacturer and model
• installation date
• planned preventive maintenance record
• validation record
• daily, weekly, quarterly and annual test records where the current HTM 01-05 source requires them
• fault reports and service engineer reports

Staff do not restate test frequencies from memory. They use the current HTM 01-05 source and the manufacturer's instructions when setting the local test schedule.

9. Responsibilities

• Registered Manager: owns this policy, ensures the Practice has suitable premises, equipment, training and audit arrangements, and signs off annual review.
• Decontamination lead: maintains the local procedure, equipment files, validation records, decontamination logs and audit schedule.
• Dentists and dental therapists: ensure instruments used in treatment have passed through the approved decontamination cycle and report any contamination or traceability concern.
• Dental nurses: carry out the decontamination cycle only after training and competency sign-off. They record cycles, checks and rejected instruments.
• All clinical staff: keep dirty and clean flows separate, follow standard infection prevention precautions and report faults immediately.

10. Recording requirements

The decontamination record should include:

• date, time, operator, equipment and cycle or batch identifier
• instruments or load, process used and release outcome
• required cycle parameters and test result from the approved local schedule
• cleaning, inspection, sterilisation and packaging exception
• failed cycle, quarantine decision, investigation, reprocessing and release authorisation
• patient or procedure traceability where required by the local process
• validation, maintenance, fault and service record reference
• rejected instrument and disposal or repair decision
• staff training or competency restriction where relevant
• linked incident, risk, audit finding or improvement action

Records are kept in the Practice's governance records and are available for internal audit, CQC review and external review where required.

11. Audit cadence

The Practice uses the following Verivius default audit rhythm unless the current HTM 01-05 source, commissioning requirement or local risk assessment requires more frequent review:

• Daily: staff complete the local decontamination process checks and record failed cycles or rejected instruments.
• Weekly: the decontamination lead reviews logs for missing entries, failed cycles, equipment faults and traceability gaps.
• Monthly: the Registered Manager or delegated clinical lead reviews a sample of instrument journeys from surgery to storage.
• Annually: the Practice completes a full decontamination audit against HTM 01-05 and updates the improvement plan.

Any audit finding is recorded as an improvement action with an owner and review date.

12. Version control and review date

The Practice keeps a controlled copy of this policy. The footer or document-control table records:

• policy owner
• version number
• date approved
• next review date
• changes made since the last version
• source material checked during the review

13. Related records

• Infection prevention and control audit
• Premises and equipment policy
• Sharps policy
• Waste-management policy
• Staff training matrix
• Equipment maintenance file
• Decontamination log

Review cadence: annual or on regulatory change, whichever sooner. Owner: Registered Manager.

14. Related policies in this pack

• Infection prevention and control policy
• Clinical waste and sharps safety policy
• Premises and equipment policy
• Incident reporting, investigation and learning policy
• Training, competency and mandatory training policy

15. Sources and further reading

This template is based on CQC's guidance for providers and managers, the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, and other topic-specific legislation and guidance listed below. It is a starting point for adaptation, not a substitute for legal, clinical, HR, safeguarding or specialist professional advice.

• CQC Regulation 12: Safe care and treatment
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (https://www.legislation.gov.uk/uksi/2014/2936/regulation/12)
• HTM 01-05: Decontamination in primary care dental practices, NHS England publication page updated 26 January 2024. Providers must check the live NHS England source before relying on detailed test frequencies, storage periods or audit tools.
• GDC Standards for the Dental Team
• Health and Social Care Act 2008 Code of Practice on the prevention and control of infections (the IPC Code)
• CQC dental guidance and current assessment material for infection prevention and control

16. When to seek further advice

Seek specialist advice where the issue involves serious harm, safeguarding, deprivation of liberty, restraint, children, professional misconduct, controlled drugs, radiation, termination of pregnancy, infection outbreak, water safety, employment dismissal, DBS barring referral, or regulatory enforcement.

17. Document control

This sample policy template was issued by Verivius. It is a template, not a substitute for legal advice or the provider's own policy-development process. Where this template and live law or regulator guidance diverge, the live source wins.