Sample policy · Ophthalmology

Decontamination of ophthalmic instruments policy (ophthalmology)

Statutory anchor: Regulation 12 (safe care and treatment), Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (SI 2014/2936). This policy also engages Regulation 15 (premises and equipment). · primary source

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

5. Scope

This policy applies to:

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:

8. Inspection, sterilisation and validation

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:

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:

Operational controls to adapt

Roles and responsibilities

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:

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:

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.

Related reading

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

Version Date Author Changes
v1.1 2026-07-14 Verivius (sample) Added role ownership, decontamination procedure, record fields, register links and related reading.
v1 2026-06-10 Verivius (sample) Initial sample template, conformed to the Verivius policy standard.

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.

What good looks like here

Written from an ex-CQC inspector's chair, but the point is safe, well-led care your team can stand behind. Each row shows what strong evidence looks like, what thin evidence looks like, and where the expectation comes from.

Decontamination is the policy where the danger is a residue you cannot see rather than a germ you can culture: the eye is so intolerant of what is left on an instrument that a trace of viscoelastic, detergent or enzyme carried into the next case can set off toxic anterior segment syndrome, a fierce sterile inflammation that arrives after an operation that went perfectly. Sterility failures add infection on top, and neither harm announces itself at the time, which is why the whole safety of the system rests on records made before anyone is hurt rather than after. The traceability trail is the part that decides everything later: when a reprocessing failure surfaces, being able to walk a given set back to a named patient is the difference between recalling the handful of people actually exposed, recalling a whole clinic because you cannot tell, and recalling nobody because the link was never kept. Instruments that touch the retina or optic nerve carry a further, rarer worry, the theoretical transmission of variant Creutzfeldt-Jakob disease, which is why the guidance points to single-use or quarantine for the posterior segment rather than ordinary reuse. None of this is visible to the person on the table, and it stays safe only while the validated cycle, the retained cycle records, the single-use discipline and the set-to-patient link are all genuinely working. The evidence here is not paperwork for an inspection; it is the proof that the next eye was thought about before the last instrument was put away.

  1. The service can name which instrument set went through which sterilisation cycle and into which patient, so that if a reprocessing failure later comes to light the people actually exposed can be found and recalled, not a whole clinic list contacted because nobody can tell who was affected, and not nobody contacted because the link was never kept. Loan and borrowed sets carry the same trail: their decontamination status is recorded on arrival and before use, and a set whose decontamination cannot be assured is not used.

    Strong evidence: The traceability record linking each set reference to the patient, procedure and date and to the sterilisation cycle it was released from, kept in line with Health Technical Memorandum 01-01, and the loan-set log recording decontamination status on receipt; the periodic decontamination audit that samples these links end to end.

    Weak evidence: The service can describe the process and produce sterilisation cycle printouts, but cannot walk a given set back to the named patient it was used on, so a recall would mean contacting everyone or no one. Loan sets go straight onto the list with nothing recorded about how, or whether, they were decontaminated before they arrived.

    What the regulator expects to see. Not a law in itself, but CQC judges you against it, so an inspector will look for it and expect a reason where you depart from it.

  2. Instruments are sterilised through the validated cycle the steriliser manufacturer and current decontamination guidance specify, and the sterile set the surgeon opens has been released against that cycle, so a set is not used on the strength that the machine 'looked fine'. The washer-disinfector and steriliser are serviced, validated and periodically tested to the schedule the guidance and manufacturer require, the cycle records are retained, and a failed cycle or a fault takes the equipment and its load out of use until it is put right.

    Strong evidence: The retained sterilisation cycle records linked to the sets they released, the service, validation and periodic test certificates for the washer-disinfector and steriliser held current, and the quarantine record for any failed cycle or faulty machine; the decontamination equipment schedule the Registered Manager reviews.

    Weak evidence: Cycle records not kept, or kept but never linked to the sets they released, so a later query cannot be answered. Service or validation certificates out of date, missing, or covering a machine that has since been moved or replaced. A failed cycle noted but the load released anyway, or a fault worked around rather than taking the machine out of use.

    A legal duty. This comes from legislation that applies to your service, so meeting it is not optional. The exact provision is cited beneath the badge.

    Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, reg 12(2)(e) (equipment safe and used safely) and reg 15(1) (premises and equipment clean, suitable, maintained and properly used). The precise validation and testing method remains manufacturer and HTM guidance.

  3. An item the manufacturer marks single-use is used once and discarded, never cleaned and put through a second patient, so a single-use cannula, blade or tip is not quietly reprocessed to save a set. The service keeps a record of which items are single-use, so the line between reuse and discard is held by policy rather than decided from memory at the bench.

    Strong evidence: The single-use register or catalogue naming the items designated single-use, the manufacturer instructions for use those designations come from, and the decontamination audit checking that single-use items are not reappearing in the reprocessing flow.

    Weak evidence: Items carrying the manufacturer's single-use symbol turning up in the cleaning and sterilisation flow. No list of what is single-use, so the reuse-or-discard call is made afresh at the bench each time. An audit that never looks for single-use items being reprocessed.

    The instructions from the maker of a product, device, or medicine. Following them is how the item is used safely, and for medical devices it is effectively expected.

  4. Instruments are cleaned promptly and to the manufacturer's instructions before viscoelastic or other material can dry on them, with the fine lumens of cannulated handpieces flushed through and detergent or enzyme rinsed off, so no residue is carried into the next eye, because it is residue, not only microbes, that triggers toxic anterior segment syndrome. The cleaning agents and processes stay within the limits each instrument's instructions for use set, rather than a single house method applied to every instrument.

    Strong evidence: The cleaning procedure specifying prompt cleaning, lumen flushing and thorough rinsing keyed to the manufacturer instructions for each instrument, the Royal College of Ophthalmologists toxic anterior segment syndrome guidance it is anchored to, and the periodic audit sampling cleaning against that procedure alongside tracking of post-operative inflammation patterns.

    Weak evidence: A single generic cleaning method applied to every instrument regardless of what its instructions for use allow. No step addressing lumen flushing or rinsing, so viscoelastic, detergent or enzyme residue can ride into the next case. Cleaning left until later so material dries on. No tracking of post-operative inflammation that would surface a residue problem before it became a cluster.

    The recognised standard from a professional or clinical body, such as NICE or a royal college. Not a legal duty, but the accepted mark of safe practice, and a departure needs a documented reason.

  5. For instruments that contact the retina, optic nerve or posterior segment, the service follows the current guidance on reducing the theoretical risk of transmitting variant Creutzfeldt-Jakob disease, using single-use instruments or the quarantine arrangements that guidance sets, and confirms the current position with its decontamination adviser rather than assuming ordinary reprocessing is enough. The route chosen for these instruments is recorded, not left to custom.

    Strong evidence: The recorded decision for posterior-segment instruments, single-use or quarantine, referenced to the current national guidance, and the dated confirmation from the decontamination adviser held on file.

    Weak evidence: Retina and posterior-segment instruments run through the ordinary reprocessing route with no consideration of the variant Creutzfeldt-Jakob disease position at all. A decision taken once, years ago, with no note of which guidance it rested on and no recent confirmation from a decontamination adviser.

    The recognised standard from a professional or clinical body, such as NICE or a royal college. Not a legal duty, but the accepted mark of safe practice, and a departure needs a documented reason.

  6. When a cleaning, sterilisation or traceability failure is found, or a cluster of post-operative inflammation points to toxic anterior segment syndrome, the affected instruments come out of use at once, the patients who may be affected are identified through the traceability records and clinically reviewed, and the event is investigated as a patient-safety incident with the cause found and fixed before the instruments go back into use, not the set kept in circulation while someone decides whether it matters. Where the harm threshold is met, the duty of candour to the person is opened as its own duty, separate from any statutory notification to CQC.

    Strong evidence: The incident record opening the failure, the list of patients identified from the traceability records and the clinical review of them, the root-cause finding and the recorded return-to-use decision, and the duty-of-candour record where the threshold is met; the register showing failed cycles, damaged instruments and missing traceability are opened as incidents.

    Weak evidence: A suspected reprocessing failure left in service while it is 'looked into', with no set taken out of use. No line reaching from the failure to the patients who might have been exposed, because the traceability records cannot support it. An incident closed on a cleaning point with no recorded cause and no candour consideration, so a person owed an open account of what happened is never told.

    What the regulator expects to see. Not a law in itself, but CQC judges you against it, so an inspector will look for it and expect a reason where you depart from it.

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Last verified 23 July 2026

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Last reviewed 10 June 2026