1. 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.
2. 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
3. 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
4. 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.
5. 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
6. 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
7. 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
8. 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.
9. 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
10. 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.
11. 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.