Ophthalmic Services Guidance

Managing an outbreak of postoperative

endophthalmitis

July 2016

18 Stephenson Way, London, NW1 2HD T. 020 7935 0702

[email protected] rcophth.ac.uk @RCOphth
© The Royal College of Ophthalmologists 2016 All rights reserved

For permission to reproduce and of the content contained herein please contact [email protected]
Contents

Section page
1. Introduction 3
2. Sources of causative microorganisms 3
3. Routine prophylaxis against endophthalmitis 4
Operating theatre general measures 4
Preoperative 4
During procedure 4
Preventive measures 5
4. Treatment of cases 5
5. Active monitoring of incidence and investigation of isolated cases 5
6. How many cases comprise an outbreak? 6
7. What should raise particular concerns? 6
8. Actions once suspicions have been raised 7
9. Notification and involvement of others, raising awareness, detecting cases 7
10. Immediate actions to improve prophylaxis/prevent further cases 8
11. Investigation 8
12. Summary 9
13. Flow chart - Coping with a cluster of postoperative endophthalmitis 10
14. References 11
15. Authors 12

Date of review: July 2019

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 1. Introduction

The aim of this document is to provide advice on the identification and management of an
outbreak of post ophthalmic procedure (post-op) endophthalmitis. The guidance will
concentrate particularly on cataract surgery, but the principles and much of the detail are
applicable to other intraocular procedures including intravitreal injections. As much is
possible is based on published evidence but, in the absence of published high quality
evidence for many aspects, expert consensus has been used to make recommendations.
Acute endophthalmitis is a severe intraocular inflammation presumed to be due to entry of
microbes into the eye during the perioperative period. It is identified usually in the first two
weeks after surgery and presents as a red painful eye with severe anterior uveitis, often with
fibrin and hypopyon, and vitritis. It is not always culture positive. It is one of the most serious
postoperative complications of intraocular procedures and, despite treatment, often results
in a very poor visual outcome. The incidence in the developed world is low, approximately
0.1-0.08%, with an incidence in the UK (as determined by BOSU in 20045) of 0.14% after
cataract surgery and approximately 0.02-0.06% after intravitreal injections.
Many units may face a possible or actual cluster of cases (“outbreak”) of post-op
endophthalmitis at some point and a logical method of investigating and tackling this is key
to reducing harm to patients and minimising operational disruption to the ophthalmology
service.
A summary sheet and check list is included at the end

2. Sources of causative microorganisms

Most cases of sporadic isolated postoperative endophthalmitis arise from the patient’s own
commensal bacteria (Staphylococci and Streptococci) and are mainly (60-80%) gram positive
cocci. However, clusters of cases have a greater likelihood of arising from some particular
source of contamination and have a much greater chance of being gram negative bacteria
(Coliforms or Pseudomonas) or fungal with potentially worse outcomes.
Sources of contamination in outbreaks include:
 Contaminated intraprocedural solutions both extraocular (e.g. povidone iodine,
saline) and intraocular (e.g. irrigating fluid, intracameral drugs including
antibiotics, anti-VEGF, dyes and viscoelastic). This is the commonest source in
clusters.
 Contaminated phaco machines including tubing and phaco probes
 Inadequate ventilation systems providing poor air change rate per hour in the
operating environment
 Defective sterilisation procedures
 Miscellaneous e.g. defective, contaminated or dirty instruments
 Some have more than one source
 In approximately 20% there is no obvious or identifiable source

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 3. Routine prophylaxis against endophthalmitis

The low incidence of endophthalmitis makes it difficult to obtain robust evidence of the
efficacy of preventative measures in reducing its occurrence. Although this is not a full
guideline on how to avoid endophthalmitis, and detailed guidance and assessment of the
evidence exists within The Royal College of Ophthalmologists’ cataract guidelines and
elsewhere, there are a number of areas where there is general consensus on what is good
ophthalmic theatre practice or likely to offer a benefit:

Operating theatre general measures

 Rigorous theatre procedures including thorough hand washing, following strict
theatre discipline to maintain sanctity of preparation and sterile areas to avoid
contamination, separation of clean and dirty areas and minimization of
unnecessary theatre traffic.
 Proper environmental cleaning.
 Maintain and monitor performance (annual preventive planned maintenance –
PPM schedule) of theatre/clean room ventilation/airflow systems to appropriate
standards.
 Following manufacturers’ guidelines regarding single use of instruments.
 Follow manufacturers’ guidelines on cleaning, disinfection and sterilisation of
instruments and devices. Ensure theatres and the sterilizing unit comply with
appropriate related standards.

Preoperative
 Avoidance of intraocular procedures in patients with significant active non-ocular
infections
 Treatment of patients with blepharitis, significant lid malpositions (e.g. entropion
with lashes abrading ocular surface), infective conjunctivitis and nasolacrimal
infections prior to procedure.

During procedure
 Skin preparation with povidone iodine or chlorhexidine if allergic to povidone
iodine.
 Povidone iodine solution 5% instilled into the conjunctival sac prior to
commencement.
 Good draping technique to isolate the lid margins and lashes from the surgical
field.
 Ensuring all equipment, intraocular lenses, viscoelastics, drugs and solutions are
from a reliable source.
 Rejection of instruments which are damaged, faulty or show signs of poor
cleaning such as debris or deposits. Do not clear blocked instrument lumens e.g.
of an irrigation-aspiration cannula during the procedure as sterility may then be
uncertain.
 Excellent surgical wound construction and good wound closure.
 Avoidance of serious intraoperative complications especially posterior capsular
rupture and vitreous loss and avoidance of overly prolonged surgery.
 Prophylactic antibiotics in accordance with the RCOphth (or equivalent) surgery
and procedure guidelines where indicated. It is not currently mandated by the
College to use intracameral antibiotics in cataract surgery as long as

2016/PROF/336 4
 endopthalmitis rates are satisfactory but it is worth noting that some authors
believe it to be superior to other methods of delivery, such as topical and
subconjunctival.
 Any other procedure which, after the preparation of this guide, is shown with
good statistical support to be effective and safe.
Preventive measures
Suggested by some authors, but for which there is little consensus or evidence, include:
 Non-touch technique as far as possible, avoiding contaminating the functional
end of instruments.
 Rejection of lens implants which have inadvertently contacted the lid margins.
 Wear facemasks in theatre, especially scrub nurses and surgeons.
 Preoperative topical broad spectrum antibiotics.
 Injecting lens implants rather than folding them with forceps, in order to reduce
the possibility of contact with the lid margin.
 Single use/disposable instruments.
 Single use medications.
 Postoperative antibiotic drops (regimens vary but usually one-two weeks).

4. Treatment of cases

It is beyond the bounds of this document to detail the treatment of endophthalmitis.

However, it is important, even if briefly, to mention two important points of principle:

1. This is a condition where time is of the essence. It is crucial that cases are
diagnosed early and treated as an emergency. If there is enough clinical
suspicion of endohthalmitis, treatment should not be delayed waiting for
microbiological confirmation or the effects of a trial of steroids.

2. All units or surgeons undertaking intraocular surgery or intravitreal injections,

whether within the NHS or independent sector, have a duty to ensure their
patients can access emergency assessment and treatment of endophthalmitis.
All patients should be warned what to look out for postoperatively and given
clear information on where to go or whom to call if they are concerned. There
should be clear agreed pathways for care if a provider of the procedure is not
able to offer emergency post-procedure care.

5. Active monitoring of incidence and investigation of isolated

cases

Postoperative endophthalmitis cases should be reported to the hospital risk management

team usually via the incident reporting system. All incidents reported locally are normally
shared nationally with the National Reporting and Learning System to detect national trends.

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For cases of endophthalmitis which have arisen at another unit, the ophthalmic clinical lead
and the operating consultant of the source unit must be informed about the case by the
receiving/treating unit so that they can incident report and investigate. In the unfortunate
event that the source unit does not seem to reply/act/engage, whether NHS or independent,
the commissioner should be notified directly.
Ophthalmology audit or clinical governance meetings should include a regular complications
and morbidity slot which should consider any cases of endophthalmitis and examine any
predisposing factors or areas for action, learning or improvement.
Electronic patient records can facilitate continuous audit and surveillance, and identify even
a small rise in endophthalmitis cases or other complications which might not otherwise be
evident.
Either via electronic patient records, incident reporting or both, incidence should be
regularly monitored. Departments should have a system for identifying and acting upon any
rise in incidence or cluster of cases.
Report to the Medicines and Healthcare products Regulatory Agency, and to the
manufacturers, any problems with drugs or devices.

6. How many cases comprise an outbreak?

This is a difficult question to answer as random clusters mimicking an outbreak may occur
from time to time. With such a low background incidence, even one or two extra events
during a short time frame can raise concerns but may turn out not to be significant and may
be followed by an unusually long period with no cases so that the frequency over a longer
time frame may be within acceptable limits.
It is important to consider the possibility that more than one case in a short time frame may
have arisen from a preventable and recurring cause.

7. What should raise particular concerns?

 Analysis of the cases demonstrate a common organism especially an unusual

organism
 Analysis of the cases demonstrates the same apparent underlying cause or
concern
 Analysis of the cases demonstrates the cases related clearly to only one team
member, one surgeon, one theatre/site, one session in the week (for all of these
especially if significantly out of proportion to the relevant share of surgical
activity), a particular instrument or consumables batch number.
 Two or more cases have arisen during the same theatre list.
 A rate that is significantly over that expected in the modern era; in cataract
surgery this might perhaps be >0.4% and above; and a rate that is >0.8% should
be taken extremely seriously.
 Cluster occurring over a very short time frame e.g. days to weeks.

2016/PROF/336 6
  Some have used statistical methods or charts to ensure a sensible balance
between complacency and overkill. There are a number of methods (see
references). It is wise to involve the local microbiologist in determining the best
local method for this and even wiser to have done so proactively before any
suspected cluster rather than reactively after concerns have been raised.

8. Actions once suspicions have been raised

The degree of action will of course depend on both the rate of occurrence, any suspicious
factors and whether the problem persists. Operational factors have to be taken into
consideration but the first duty is to minimise patient harm.
Keep detailed records of all action taken and minute any meetings.
Decision as to whether or not there is an outbreak (see above) based on frequency, possible
statistical analyses and identification of common factors in the cases.

9. Notification and involvement of others, raising awareness,

detecting cases

 Alert colleagues: make them aware of the cases so far, ask if there are other
cases not yet reported, advise a high degree of suspicion and to report any
further cases.
 Ensure incident reports are completed for any cases.
 Alert the lead clinician, clinical director and the medical director.
 If receiving multiple cases from another provider, their clinical lead and medical
director must be notified and take action. If their response is deemed
inadequate, contact their commissioner.
 Involve the hospital consultant microbiologist and hospital infection team at an
early stage.
 Involve the risk team and consider notifying commissioners.
 With risk team notify MHRA and manufacturers if devices or drugs are clearly
implicated.
 Consider establishing a multidisciplinary team to manage and investigate
(ophthalmologists, nurses, theatre staff, managers, risk, microbiology, infection
control).
 Verify that patients are fully aware of postoperative danger symptoms.
 Consider resuming day two or day three follow-up if this is not normally
undertaken.
 Ask neighbouring units if they also have noticed an increased incidence of
endophthalmitis.

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 10. Immediate actions to improve prophylaxis/prevent further
cases

 Ensure that established agreed theatre procedures and preventative measures

are robust and being followed and remind staff about them.
 Cease bilateral simultaneous cataract surgery where performed
 Temporary closure of theatre(s) or provision of the procedure: give serious
consideration to cessation of all intraocular surgery in the interests of patient
safety whilst investigating the cause.

11. Investigation

1. Review cases urgently and examine:

 Patient/surgical risk factors such as blepharitis, nasolacrimal disease,
immunosuppression/diabetes, concurrent systemic infection etc, vitreous loss,
duration of surgery, postop wound leak, non-compliance with prescribed drops.
 Surgeon factors surgical and draping technique.
 Common hospital factors such as draping and procedural technique,
antibacterial prophylaxis, surgeon, nursing staff and other personnel, theatres,
solutions, drugs, viscoelastics, intraocular lenses, disposable and non-disposable
equipment, which autoclave used, on which day of the week, which position on
the list and at what time of day patients were operated. Track batch numbers of
solutions, drugs, disposables and lenses.
 Ensure there is appropriate documentation of practices, instrumentation and
drugs.
2. Note any procedure or environment which coincided with or recently preceded the
outbreak.

3. Microbiological analysis of intraocular tap samples, looking for a common organism

or subtype - fully subtype any organisms (investigation methods to determine the
source of these outbreaks use a combination of phenotypic [routine culture,
biochemical profiles of the organism, antibiotic susceptibility patterns] 8,10,17 and
molecular [e.g. 16s PCR polymerase chain reaction in culture negative
specimens/tap]).

4. Environmental considerations: building works in or nearby, poor condition of estates,

level of cleanliness, clutter and ergonomics, separation of dirty and clean areas and
condition of equipment. Confirm that the ventilation/ air-flow is appropriate and
tested in consultation with the infection control team. Check what other cases (e.g.
dirty cases) are being performed in the theatre or nearby from theatre records.

5. Microbiological sampling: may include microbiological sampling/culture from

irrigating solutions, extra and intracameral solutions and drugs, viscoelastics. Sample
phaco sets (tubing, phaco and I/A handpieces) and phaco machine, air filters and
ventilation units, and environmental swabbing of theatre areas.

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 6. Review theatre practices: independent observation of practices such as door
closures, staff movements, facemasks, drugs and instrument prep and use, solution
and drug handling etc.

7. Review surgical techniques and IOL handling.

8. Assess that all equipment and disposables are functional and used according to
manufacturer’s instructions, are in date and appropriately serviced. Confirm single
use where instruments are so designated.

9. Assess efficacy of cleaning and sterilization processes, in particular examine how

reusable hollow bore equipment lumens are rinsed or cleaned. Arrange for
professional assessment of the hospital sterilizing service. Look actively by examining
instruments for damage or debris and blocked lumens.
Address the specific cause if one is found
Actions when a specific cause cannot be found
 Review and revise current prophylaxis protocol and re-examine and if possible
improve any other relevant preop, intraoperative and postoperative care and
theatre activities.
 Consider introducing extra prophylaxis measures (see above) e.g. intracameral
antibiotics
 Consider an external review by a neighbouring unit or The Royal College of
Ophthalmologists.

12. Summary

Units should have robust protocols for endophthalmitis prevention, and methods to monitor
the incidence. It is important to identify a significant rise in incidence and analyse and learn
from sporadic cases. The discovery or suspicion of an outbreak of endophthalmitis should
prompt a rapid, systematic and open investigation to attempt identification and remedy of
any possible cause. Patient safety is paramount and may involve temporary cessation of
intraocular procedures.

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13. Flow chart - Coping with a cluster of postoperative
endophthalmitis

• Incident report all cases

• Review cases for risks and causes; suspicion if common factors (e.g.
surgeon, theatre, batch number, isolate, instruments)
Is there a • Regularly assess incidence, use agreed system as cut off for action
cluster? •  suspicion if very high rate or cluster over very short time

• Notify/involve colleagues - ophthalmology, CG/risk, infection control,

microbiology, management
• Make patients aware of symptoms and provide easy emergency postop
access
Notification • Consider resuming early follow-up

• Consider cessation all surgery/procedures

• Cease bilateral simultaneous cataract surgery if performed
Immediate • Ensure all know and follow current prophylaxis regime
measures

• Review cases check all aspects for risks and common factors
• Check theatre environment, cleanliness, airflow/ventilation system
• Microbiological sampling equipment, theatre, drugs, solutions
• Review and obey theatre discipline and correct operating practices
• Ensure equipment/devices up to date, used properly, maintained well
• Check instrument cleaning and sterilisation procedures
• Keep detailed records of investigations and actions
Investigation • Eliminate specific cause if found
• Revise and improve prophylactic measures
• Introduce intracameral antibiotics
• Consider external review from other unit or College

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14. References

1. Endophthalmitis after intravitreal Injection: prevention and management.

Wykoff C, Flynn HW. Retina 2011;31:633-5.
2. American academy of Ophthalmologists Intravtireal statement 2015.
http://www.aao.org/clinical-statement/intravitreal-injections--november-2008
3. Endophthalmitis after intravitreal injections: incidence, presentation,
management, and visual outcome. Dossarps D, Bron AM, Koehrer P, et al. Am J
Ophthalmol 2015;160:17-25.
4. Intravitreal Injections at the Massachusetts Eye and Ear Infirmary: analysis of
treatment indications and post injection endophthalmitis rates. Englander M,
Chen TC, Paschalis Ei et al. Br J Ophthalmol 2013;97:460-465
5. Surveillance of endophthalmitis following cataract surgery in the UK.
Kamalarajah S, Silvestri G, Sharma N, Khan A, Foot B, Ling R, Cran G, Best R. Eye
2004; 18: 580-7.
6. Monte–Carlo simulation of random clustering of endophthalmitis following
cataract surgery. Sparrow JM. Eye 2007; 21: 209–213.
7. The use of control charts in monitoring postcataract surgery endophthalmitis.
Chiam PJT, Feyi-Waboso A. Eye 2009;23:1028-31.
8. A statistical approach to an outbreak of endophthalmitis following cataract
surgery at a hospital in the West of Scotland. Allardice GM, Wright EM, Peterson
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98:639-49.
10. Endophthalmitis isolates and antibiotic sensitivities: a 6-year review of culture-
proven cases. Benz MS, Scott IU, Flynn HW, Unonius N, Miller D. Am J
Ophthalmol 2004;137:38-42.
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Menikoff JA. Ophthalmology 1991;98:1769-75.
12. Bacterial endophthalmitis prophylaxis for cataract surgery: an
13. evidence-based update. Ciulla TA, Starr MB, Masket S. Ophthalmology
2002;109:13-26.
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15. Antibiotic prevention of postcataract endophthalmitis: a systematic review and
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 19. An investigation into postoperative endophthalmitis and lessons learned.
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15. Authors

The Royal College of Ophthalmologists’ Quality and Safety group, Chair Mrs Melanie
Hingorani FRCOphth

July 2016

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