Intravitreal injection safety 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 persons providing care or treatment to service users have the qualifications, competence, skills and experience to do so safely, (Reg 12(2)(c) (staff competence))

where equipment or medicines are supplied by the service provider, ensuring that there are sufficient quantities of these to ensure the safety of service users and to meet their needs, (Reg 12(2)(f) (sufficient equipment + medicines supply))

the proper and safe management of medicines, (Reg 12(2)(g) (medicines management))

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

Intravitreal injections, most often anti-VEGF drugs for age-related macular degeneration and diabetic macular oedema, are among the highest-volume procedures an independent eye clinic performs. The most serious complication is endophthalmitis, a sight-threatening infection inside the eye. This policy sets out how the Service gives intravitreal injections safely: the right drug in the right eye, a clean aseptic technique that lowers the risk of infection, and clear advice and follow-up so that infection is caught and treated early.

The Service must verify this policy against current Royal College of Ophthalmologists guidance on intravitreal injection and the drug manufacturers' instructions before adoption.

4. Sources to verify before adoption

• Royal College of Ophthalmologists, intravitreal injection guidance and Ophthalmic Services Guidance: https://www.rcophth.ac.uk/
• The Summary of Product Characteristics for each anti-VEGF or steroid agent used (dose, preparation, storage)
• MHRA Yellow Card scheme for adverse drug and device reactions: https://yellowcard.mhra.gov.uk/
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 12 (safe care and treatment): https://www.legislation.gov.uk/uksi/2014/2936/regulation/12
• The Service's correct patient, correct eye, correct lens policy (for the eye and drug confirmation)

5. Scope

This policy applies to:

• every intravitreal injection the Service gives, whatever the drug
• the preparation, the injection, and the aftercare
• the clinicians who inject, the nurses and staff who prepare and assist, and the staff who give and record safety-netting advice

6. The right drug, dose and eye

Before any injection the team confirms, against the clinical record and the treatment plan:

• the patient's identity, using at least three identifiers
• the eye to be injected (per the correct patient, correct eye, correct lens policy)
• the drug, the dose and the strength, checked against the prescription or protocol
• the drug's expiry, storage history and, where relevant, that it has reached the correct temperature for use

The eye, the drug and the dose are confirmed aloud immediately before injection.

7. Aseptic technique and infection prevention

The Service follows an aseptic, no-touch technique designed to lower the risk of endophthalmitis:

• the injection is given in a clean, suitable room kept for the purpose, not in a busy general area
• hand hygiene and sterile or clean gloves are used per the technique the Service adopts
• the ocular surface and lids are prepared with povidone-iodine (or an agreed alternative where the patient is allergic), left in contact for the time the evidence supports, as the single most important step in preventing infection
• a sterile lid speculum keeps the lashes and lid margin away from the needle
• single-use sterile equipment and a single-use needle are used for each injection, and the injection site avoids the patient talking or coughing directly over the field; some services use a face mask or a no-talking rule to reduce this risk
• the drug is drawn up and the injection given without the needle touching the lids, lashes or any non-sterile surface

The Service confirms its exact technique against current Royal College of Ophthalmologists guidance.

8. After the injection

• the eye is checked, and intraocular pressure is assessed or monitored where the Service's protocol requires it
• the patient is given clear safety-netting advice, in a form they can keep, on the symptoms of endophthalmitis (increasing pain, increasing redness, falling vision, increasing floaters or light sensitivity) and told to seek urgent help the same day if any occur
• the patient is told exactly how to reach urgent help, including out of hours, and that route is one that can actually assess an injected eye quickly
• the drug, dose, eye, batch or lot number, and the person who injected are recorded

9. Suspected endophthalmitis

A patient reporting pain or falling vision after an injection is treated as possible endophthalmitis until proven otherwise. The Service:

• arranges urgent same-day assessment by an ophthalmologist who can examine the eye
• has a clear, tested pathway to a vitreoretinal service for the urgent treatment endophthalmitis needs, because delay costs sight
• records the event, manages it as a serious patient-safety incident, and opens the duty of candour where the threshold is met

10. Recording and reporting

• every injection is recorded with the drug, dose, eye, batch or lot number and injector
• suspected drug or device reactions are reported through the MHRA Yellow Card scheme
• endophthalmitis cases and injection-related harm are logged, investigated and reviewed for patterns (for example a cluster pointing to a batch, a room or a technique)

Operational controls to adapt

Roles and responsibilities

• Registered Manager: owns the injection-safety system and makes sure incidents, infection concerns and audit findings are reviewed.
• Injecting clinician: confirms indication, consent, drug, dose, eye, aseptic technique, aftercare advice and urgent escalation route.
• Medicines lead or nominated clinician: checks storage, cold-chain or room-temperature requirements, batch records, expiry, drug selection and recall action.
• Clinical support staff: prepare the room and patient, support identity and eye checks, give approved aftercare information and escalate post-injection symptoms immediately.
• Governance lead: reviews endophthalmitis concerns, wrong-drug or wrong-eye incidents, follow-up failures and improvement actions.

Intravitreal injection procedure

1. Confirm indication and treatment plan. Check the diagnosis, eye, drug, dose, interval, consent and whether the patient is fit for injection that day.
2. Check drug and eye. Match patient, eye, drug, dose, batch, expiry and prescription or protocol before preparation and again before injection.
3. Prepare aseptically. Follow the approved room, hand hygiene, antisepsis, draping, eyelid and no-touch technique.
4. Inject and monitor. Record the injection, immediate tolerance, any complication and whether intraocular pressure or other checks are required.
5. Give safety-netting. Explain symptoms requiring same-day urgent contact, including increasing pain, reduced vision, redness or discharge.
6. Provide urgent response. Treat suspected endophthalmitis, retinal detachment, severe inflammation or sudden vision loss as urgent and direct the patient to the agreed emergency route.
7. Record and review. Link drug batch, consent, eye, aftercare, complication and follow-up records. Open incidents for wrong-drug, wrong-eye, infection concern, delayed response or missing traceability.

Records and register links

The intravitreal-injection record should include:

• indication, eye, injection number or treatment interval and consent status
• drug, dose, batch, expiry, storage status and prescriber or protocol authority
• patient identity, allergy and contraindication checks
• aseptic preparation, antiseptic used and immediate tolerance
• aftercare advice and emergency contact route given
• follow-up plan, monitoring or urgent review decision
• suspected infection, wrong-drug, wrong-eye, medicine-storage issue, recall action or improvement action

Wrong-eye, wrong-drug, suspected infection and urgent-response failures are opened on the incident register. Medicine-storage risks, repeat process gaps and recall actions are tracked through the risk register and improvement-actions register.

11. Training and competency

A clinician gives intravitreal injections only after training and a check that they can do it safely, and the Service repeats the competency check on a stated cadence. Staff who prepare drugs or assist are trained in the aseptic technique and the safety-netting advice. The Service records who is competent and the next refresher date.

12. Audit cadence

The Service checks, on a stated cadence, that:

• the eye, drug and dose were confirmed and recorded for every injection
• povidone-iodine antisepsis and the aseptic technique were applied
• safety-netting advice and a working urgent route were given and recorded
• endophthalmitis cases and rates are tracked, reported and reviewed, with improvement actions completed

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

13. 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
• Royal College of Ophthalmologists intravitreal injection guidance
• Health and Social Care Act 2008 IPC Code of Practice
• CQC medicines optimisation guidance; NICE medicines guidance; MHRA alerts
• MHRA Yellow Card scheme for adverse drug and device reactions
• The Summary of Product Characteristics for each agent used
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (https://www.legislation.gov.uk/uksi/2014/2936/regulation/12)

Related reading

• Related policy: Correct patient, correct eye, correct lens policy
• Related policy: Consent for ophthalmic procedures policy
• Related policy: Decontamination of ophthalmic instruments policy
• Related policy: Medicines Management Policy

14. 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.

15. 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.