Decontamination of ophthalmic instruments policy (ophthalmology)

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 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))

Regulation 15 adds the premises-and-equipment duty that this policy also engages:

All premises and equipment used by the service provider must be ... clean, secure, suitable for the purpose for which they are being used, properly used, properly maintained, and appropriately located for the purpose for which they are being used. (Reg 15(1): the six criteria)

The full text is at https://www.legislation.gov.uk/uksi/2014/2936/regulation/12 and https://www.legislation.gov.uk/uksi/2014/2936/regulation/15. 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. Premises and equipment must also be clean, secure, suitable for purpose, properly used and maintained, and appropriately located.

3. Purpose

Ophthalmic instruments are fine, delicate and reused, and the eye is intolerant of any residue left on them. Inadequate cleaning can leave detergent, enzyme or viscoelastic residues that cause toxic anterior segment syndrome (TASS), a serious sterile inflammation after surgery, and inadequate sterilisation can cause infection. This policy sets out how the Service cleans, sterilises and tracks its ophthalmic instruments so they are safe for the next patient.

The Service must verify this policy against current decontamination guidance (the relevant Health Technical Memoranda) and Royal College of Ophthalmologists guidance before adoption.

4. Sources to verify before adoption

• Health Technical Memorandum 01-01, Management and decontamination of surgical instruments: https://www.gov.uk/government/publications/management-and-decontamination-of-surgical-instruments-used-in-acute-care
• Royal College of Ophthalmologists guidance on toxic anterior segment syndrome and instrument decontamination: https://www.rcophth.ac.uk/
• MHRA guidance on reprocessing reusable medical devices and the manufacturer's instructions for each instrument: https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 12 (safe care and treatment) and Regulation 15 (premises and equipment): https://www.legislation.gov.uk/uksi/2014/2936/regulation/12

5. Scope

This policy applies to:

• every reusable instrument used in ophthalmic procedures
• single-use items, which are used once and not reprocessed
• the staff who clean, inspect, sterilise and track instruments, and the surgeons who use them

6. Single-use first

Where a single-use instrument or item is available and appropriate, it is used once and discarded, and never reprocessed. Single-use cannulae, blades and similar are not cleaned and reused. The Service keeps a record of which items are single-use.

7. Cleaning to prevent toxic anterior segment syndrome

Because residues on an instrument can injure the eye, the Service:

• cleans instruments as soon as possible after use, before viscoelastic, ophthalmic viscosurgical device or other material can dry on them
• flushes the fine lumens of cannulated instruments (for example irrigation and aspiration handpieces) thoroughly so no residue remains
• rinses instruments well after detergent or enzymatic cleaning so no detergent or enzyme residue is carried into the next case
• follows the manufacturer's instructions for each instrument, including any limits on the cleaning agents and processes that can be used

8. Inspection, sterilisation and validation

• instruments are inspected for cleanliness, damage and function after cleaning and before sterilisation, under magnification where needed
• instruments are sterilised in a validated steriliser (autoclave) operated and maintained per its instructions, with cycle records kept
• the decontamination equipment is serviced, validated and tested on the schedule the guidance and the manufacturer require, and faults take it out of use until fixed

9. Traceability

The Service can trace which instrument set was used on which patient, so that if a decontamination problem is found, the affected patients can be identified:

• each set carries a reference, and the set used is recorded against the patient and the procedure
• sterilisation cycle records are kept and linked to the sets processed in them
• where instruments are borrowed (loan sets), the Service records their decontamination status on arrival and before use, and does not use a set whose decontamination cannot be assured

10. Instruments that contact the retina or posterior segment

For instruments that contact the retina, optic nerve or posterior segment, the Service follows the current guidance on reducing the theoretical risk of transmitting prion disease (variant CJD), which may include single-use instruments or quarantine arrangements. The Service confirms the current position with its decontamination adviser before adoption.

11. When a decontamination problem is found

If a cleaning, sterilisation or traceability failure is found, or a cluster of post-operative inflammation suggests TASS:

• affected instruments are taken out of use at once
• the patients who may be affected are identified through the traceability records and clinically reviewed
• the event is logged, investigated as a patient-safety incident, and the duty of candour is opened where the threshold is met
• the cause is found and fixed before the instruments return to use

Operational controls to adapt

Roles and responsibilities

• Registered Manager: owns the decontamination system, confirms it matches current guidance and manufacturer instructions, and reviews incidents and audit findings.
• Decontamination lead: keeps the validated process, equipment checks, service records, instrument tracking and staff competency evidence current.
• Clinical and theatre staff: follow the cleaning, inspection, sterilisation, storage and traceability procedure and stop use if any step is uncertain.
• Operating clinician: confirms the required sterile set is available, suitable for the procedure and traceable to the patient.
• Governance lead: reviews decontamination incidents, failed cycles, infection concerns, audit results and improvement actions.

Ophthalmic instrument decontamination procedure

1. Check single-use first. Use single-use instruments where required by policy, manufacturer instruction or prion-risk guidance.
2. Separate used instruments safely. Keep used instruments contained and labelled so staff are protected and clean and dirty flows do not cross.
3. Clean promptly and correctly. Follow validated cleaning instructions, including flushing, detergent, water quality, timing and drying where relevant.
4. Inspect before sterilisation. Check for residue, damage, corrosion, function and completeness. Remove any failed instrument from use.
5. Sterilise using the validated route. Run the approved sterilisation process, check cycle parameters and quarantine any failed cycle.
6. Store and transport sterile sets safely. Protect packaging, expiry or event-related sterility controls, and separation from used instruments.
7. Record traceability. Link each instrument set or tray to the patient, procedure, date, cycle and operator.
8. Escalate defects immediately. Open an incident for failed cleaning, failed sterilisation, missing traceability, damaged instruments, suspected TASS or infection concern.

Records and register links

The decontamination record should include:

• instrument or tray identifier, procedure, patient and date
• cleaning method, sterilisation cycle, operator and release decision
• failed-cycle, damaged-instrument, missing-traceability or quarantine decision
• equipment validation, servicing and water-quality checks where applicable
• staff training and competency record
• manufacturer instruction or single-use decision relied on
• incident, infection-control concern, risk entry or improvement action

Failed cycles, damaged instruments, missing traceability, suspected TASS and infection concerns are opened on the incident register. Repeated process gaps are reviewed through the risk register and improvement-actions register.

12. Training

Staff who decontaminate instruments are trained and assessed as competent before they work unsupervised, and are refreshed on a stated cadence. The Service records who is competent and the next refresher date.

13. Audit cadence

The Service checks, on a stated cadence, that:

• single-use items are used once and not reprocessed
• cleaning, inspection and sterilisation follow the procedure and the manufacturer's instructions
• sterilisation cycles are recorded and decontamination equipment is validated and in date
• instrument sets are traceable to patients, including loan sets
• TASS or post-operative inflammation patterns are tracked and acted on

The Registered Manager and the clinical lead review the results and record the improvement actions that follow.

14. 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
• CQC Regulation 15: Premises and equipment
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (https://www.legislation.gov.uk/uksi/2014/2936/regulation/12)
• HTM 01-01 / HTM 01-06 where applicable
• Manufacturer instructions for use (IFUs) for each instrument
• DHSC Health and Social Care Act 2008 Code of Practice on the prevention and control of infections (IPC Code)
• Royal College of Ophthalmologists guidance on toxic anterior segment syndrome and instrument decontamination
• MHRA guidance on reprocessing reusable medical devices

Related reading

• Related policy: Surgical safety checklist policy
• Related policy: Intravitreal injection safety policy
• Related policy: Infection Prevention and Control Policy
• Regulation explainer: Regulation 12 safe care and treatment

15. 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.

16. Document control

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