“Everything in life has some risk, and what you have to actually learn to do is how to navigate it.” -Reid Hoffman
The above quote holds true for any surgical procedure whether minor or major. The biggest fear of any surgical intervention is that of infection postoperatively. Infection can occur in the best of hands and also in the most modern operating rooms. Cataract surgery is one of the most common intraocular surgeries performed in India and around 90% of postoperative endophthalmitis occurs after cataract surgery. 1
Acute endophthalmitis is severe intraocular inflammation presumed to be due to the entry of microbes into the eye during the perioperative period. It is identified usually in the initial weeks after surgery and could present as a red painful eye with severe anterior uveitis, often with fibrin and hypopyon, and vitritis. It is one of the most serious postoperative complications of intraocular procedures and, despite treatment, often results in a very poor visual outcome.2
The incidence of postoperative endophthalmitis ranges from as low as 0.02% to as high as 0.8% across the globe. 3-7 Whereas the incidence across India of clinical acute post-cataract endophthalmitis was from 0.04% to 0.15%, and the incidence of culture-positive endophthalmitis was from 0.02% to 0.09%. 8
The occurrence of infection is multifactorial. Causative factors vary from patient factors to operating room environment to consumables used in surgery to patient compliance and their hygiene post-surgery. Many institutes, mostly those doing mass surgeries may at some point have faced a cluster of cases of postoperative endophthalmitis. As such a clear definition of clusterendophthalmitis does not exist but it is stated as five or more cases of endophthalmitis occurring on a particular day from a single operating room of one center in a study published by Malhotra et al. 9
The new All India Ophthalmic Society (AIOS) guidelines state a Cluster Infection as the occurrence of two or more infections in a single day from one theatre or the occurrence of repeated postoperative infection.10 However, one or two extra events of single cases within a short time frame should raise an alarm.
In India, there are timely incidents of cluster endophthalmitis in spite of the rigorous efforts taken to avoid the same. In December 2015, the Badwani district of Madhya Pradesh had 32 patients reporting with endophthalmitis after undergoing cataract surgeries in a camp set up. In July 2016 similar incident happened to Minto Hospital in Bangalore where 24 patients have affected post-cataract surgery. In January 2019 seven patients have affected post-cataract surgery in a hospital in Mumbai. In August 2019 ten patients operated for cataract had postoperative endophthalmitis in the Indore city of Madhya Pradesh.
The occurrence of Postoperative Endophthalmitis is disastrous to the surgeon, the institute, and to the patient and his/her quality of life. It costs all of them their peace of mind and a good night’s sleep. The surgeons and the Hospital Management strive continuously to avoid such mishaps but these incidents can still occur how much ever efforts are put in. In such situations, each institute/ Surgeon should have a certain protocol regarding what to do and what not to do.
What should raise concerns?
- A common underlying causative factor.
- Cases related to a particular team member, a particular surgeon or staff member, a particular operating room in a large setup.
- A commonly isolated organism, especially an unusual one
- Cases operated with consumables of the same batch.
- Cases related to the instrumentation from the same autoclave load.
- Cases reporting over a short time frame like within days. 2
What all authorities should be notified?
- Inform the Hospital Authorities namely:
- The Medical Director
- The Retina department
- Higher Management like Administrators, Managing Trustees
- Counselors and patient Coordinators
- Inform the colleagues regarding
- The cases examined so far in a routine OPD.
- Whether any other cases reported to them.
- Report any suspicious case.
- Meticulous examination of all follows up patients.
- A higher degree of suspicion in cases of suggestive symptoms.
- Inform the staff and the registration counter to pay attention regarding the complaints of the follow-up patients and to label them as “urgent” so that their examination is speeded up.
- The reception area personnel to be advised to be patient and cordial over the phone with the postoperative patients calling to make appointments.
- Hospital Infection team, Microbiologist, and the Sterilization department.
- If the patients are coming from another institute, notify the hospital authorities of that center.
- State and district Health authorities.
- State Ophthalmic society and the All India Ophthalmic Society.
- The Legal cell / Lawyer of the institute.2
Who all to address and what to say?
- The Hospital staff and technicians who assist in routine day-to-day activities: Explain to them what has happened, its seriousness, and its implications. They should be told to be patient with their relatives and the patient. The staff should be explained the need to clean and sanitize OPD instruments and appliances like slit lamps, torches, lenses etc after every use. The need for sterile OPD instruments, sterile cotton, gauzes and ear buds is to be emphasized. The graveness of the situation is to be explained well so that they can be of assistance and do not prove a hindrance.
- Junior Doctors, Residents, and Students: Though they are from a medical background, they are relatively inexperienced to handle such situations which can have serious repercussions if handled with inexpertise. They should be taught how to and what to examine in such patients. Doses and modes of the drugs are to be taught to them. The importance of cleaning of the patient’s eye should be emphasized. Junior doctors are likely to be overburdened with paperwork, maintaining files, and reports still they need to be patient and cooperative with the patients and relatives. Any relative who is misbehaving needs to taken care of with a calm and composed attitude and the senior doctor should be notified regarding the same.
- Patients and Relatives: The patients and relatives should be counseled with composure as to the diagnosis, management, and prognosis of the situation in a reassuring way and making sure they are not scared or stressed about the event. On the other hand, the guarded nature of prognosis should not be hidden and should be clearly discussed with them. Compliance regarding the medications should be emphasized. The need for prolonged treatment and an increased amount of procedures should be explained so that the patient is mentally prepared. Regular follow-ups even after the discharge should be emphasized right from the beginning.
- Media: Media is expected to be involved in such situations and sometimes political altercations can occur. It’s always better that a senior person from the hospital management who has fair medical knowledge should correspond with media personnel. All their questions are to be answered openly and wisely. Questions regarding the prognosis are to be answered in a reassuring and confident way while not losing composure and temper. A particular time is supposed to be allotted to them and it should be made clear that they won’t be entertained any time of the day. Questions regarding visual outcomes should not be encouraged. The head of the medical team allotted to deal with media should convey to the public via media regarding what has happened, what management is going on, why the vigorous but necessary steps are taken, and what could happen if treatment is not taken properly. There should be no blame game (eg. Blaming a doctor or an institute for such an event) and medical decorum should be maintained. 7
- Contact all the patients operated on the same day or in the same operating room. Ask for any symptoms and schedule a follow up visit immediately.
- All the further operative procedures to be postponed after duly explaining the reason for postponement to the patients.
- Operation theatre to be sealed till further clearance.
- All the residual materials, drugs and devices used are to be noted, isolated and to be kept ready fir analysis. Incase the drugs or solutions are discarded items from the same batch are to be kept at ready.11
Documents to be kept ready:
- Case files of the patients including details such as demographic data, preoperative evaluation, intraoperative details, and postoperative details. Intraoperative details also include the batch number of materials used, sterilization details, IOL, and other devices used and OT staff and assistants present during surgery. The files will have detailed assessment notes, investigations, and treatment course on follow-ups.
- Surgery register from operation theatre which has details of the patients, the sequence of the patients operated, number of the patients operated in the session /day, surgeon and assistant details, the sterilization details for each individual surgery.
- Autoclave register.
- Culture reports and swab details of the OT complex register.
- AC maintenance register.
- Cleaning and fumigation register.
- Batch numbers and details from the hospital stores of the consumables used in that session/day.
- Phaco tubings sterilization, maintenance, and change record.
- Details of the intraocular lenses used.
What is the ideal Checklist of peri-operative protocols? 10
- Fasting blood sugar
- Blood pressure
- Fitness from physician or Anesthetist required.
- Ocular examination – No infection of lids or adnexa& surroundings, Sac syringing and any other contact procedure to be avoided on the day of the surgery.
- Broad-spectrum preoperative topical antibiotics
- Povidone-iodine 5% drops before surgery.
2. Operative Measures:
- Written informed consent
- Any personnel with any kind of infection should not be allowed in the OT.
- Cleaned and washed OT dress and Slippers.
- Street slippers and dress not allowed. Separate slippers for bathroom.
- Washing, gowning, gloving as per standard protocols
- Hand washing with betadine/chlorhexidine scrub for 3 minutes.
- OT etiquettes and a “No-Touch” technique to be followed strictly.
- Sterile gloves to be changed per case.
- Surgeon/assistant is not supposed to come out in OT gown
- Cap and mask should cover all the hair and nose and mouth respectively.
- Note the batch number of all consumables.
- Inspection against the light for all solutions and fluids.
- Microbiological work up and approval for each batch of consumables should be done.
- A new set of instruments for each patient should be used and the details regarding its sterilization should be duly noted.
- If the wound integrity is in doubt do not hesitate to put sutures.
- Intracameral antibiotics, subconjunctival antibiotics are to be used at the discretion of the surgeon.
3. Patient Hygiene before surgery:
- Proper hot water bath along with the head bath
- Wear clean and washed OT dress with a cap, mask, and foot covers.
- Surgery to be postponed in case of discharge or congestion
- Paint with 5% povidone-iodine on the skin and periorbital area before draping.
- 5% povidone-iodine solution to be instilled in the conjunctival sac before surgery.
- Isolate the lid margins and lashes.
- Explain to every patient about the Dos and Don’ts post-surgery after the discharge.
- Hygiene must be emphasized. Cleaning of the eyes is to be taught.
- Instillation of the medication is to be taught and demonstrated.
- First, follow up to be done preferably within the first 24 hours.
- Subsequent follow up on 3rd or 7th day followed by a 1 month follow up, depending on the hospital protocol.
- Visual acuity with pinhole should be recorded in each visit along with the examination findings on each visit.
5. Sterilization protocols:
- OT layout has to have a protective zone followed by a clean zone followed by a sterile zone and a disposal zone.
- OT to be fumigated at the end of the day.
- Disinfective mopping and cleaning of the OT
- Regular AC maintenance and cleaning.
- Sterilization of the instrument after every single use either by ETO or autoclave or flash autoclave.
- Chemical indicators to be used
- Biological indicators tests should be done every 1 or 3 months
- Registers/records to be maintained of each and every step of sterilization.
- Air swabs and surface swabs to be taken and sent for microbiology evaluation.
“Effort is never wasted, even when it leads to disappointing results. For it always makes you stronger, more educated, and more experienced.”
IN A NUTSHELL
- Preferably a separate examination area dedicated to this cluster of patients is to be created away from the main OPD area.
- A different ward is to be dedicated to these patients. The ward and OPD units dedicated for the purpose should be such that they don’t interact with the other preoperative patients or amongst themselves thereby instilling the fear of similar complications in them.
- A person from the hospital management should be made as a coordinator so that the patients/ relatives can share the problems or needs and thus makes the running of the mission smooth and successful.
- Only the senior-most doctors heading the team should talk to the patients and relatives regarding the visual outcomes, procedures, and prognosis.
- From among the team of doctors, only one doctor should be assigned to interact with the media, preferably someone who is confident, calm, and most importantly polite.
- Answer to the point and talk as less as possible while dealing with media. 7
- Endophthalmitis is a psychologically and mentally disturbing situation for the relatives and patients so do not lose cool with them while answering their questions, however silly or insignificant they might be.
- Never blame the parent institute (where the incident has happened) or the surgeon for the situation especially, even if the patient repeatedly utters bitter words for the same.
- Don’t discuss amongst colleagues while the examination is going on or during procedures, as sometimes patients might pick up some random words from your conversation and make an unnecessary fuss about it later on.
- Never compare the outcomes of two patients in front of relatives or media.
- It is better to avoid answering questions pertaining to the outcome of the procedures or the final visual outcome.
- Never avoid the media completely as they play an important role is conveying general details to the public. Avoidance can be taken and projected in a negative sense. 7
The incidence of postoperative endophthalmitis has decreased over time due to the raised standards and modernization of the infrastructure. 9 Improved practices and protocols during the perioperative period have given us an upper hand in combating this nightmarish situation. Prevention is always better than cure, but when unfortunate incidents happen it’s always better to row your boat out of rough waters rather than panicking and making the situation worse.12 Protocols and checklists help in handling the situation in an organized manner. In case the situation goes out of hand, it can have severe repercussions and mental disharmony, on the patients as well as the surgeon or institute. A quote by Joshua J. Marine says “Challenges make life interesting and overcoming those makes life meaningful.” Dealing with cluster endophthalmitis is one such challenge in an ophthalmologist’s life but here, by establishing some Do’s and Don’ts, we can try to make it relatively trouble-free and less stressful, and control the wrath of the entire circumstances.
- Verbraeken H. Treatment of postoperative endophthalmitis. Ophthalmologica 1995; 209:165-71.
- The Royal College of Ophthalmologists’ Quality and Safety group. Managing an outbreak of postoperative endophthalmitis. Ophthalmic Services Guidance; July 2016.
- Lundström M, Wejde G, Stenevi U, Thorburn W, Montan P. Endophthalmitis after cataract surgery: A nationwide prospective study evaluating incidence in relation to incision type and location. Ophthalmology 2007;114:866-70.
- Endophthalmitis Study Group, European Society of Cataract & Refractive Surgeons. Prophylaxis of postoperative endophthalmitis following cataract surgery: Results of the ESCRS multicenter study and identification of risk factors. J Cataract Refract Surg 2007;33:978-88.
- Yao K, Zhu Y, Zhu Z, Wu J, Liu Y, Lu Y, et al. The incidence of postoperative endophthalmitis after cataract surgery in China:A multicenter investigation of 2006-2011. Br J Ophthalmol2013;97:1312-7.
- Cao H, Zhang L, Li L, Lo S. Risk factors for acute endophthalmitis following cataract surgery: A systematic review and meta-analysis. PLoS One 2013;8:e71731.
- Desai SR, Bhagat PR, Parmar D. Recommendations for an expert team investigating a case of cluster endophthalmitis. Indian J Ophthalmol2018;66:1074-8.
- Prajna Lalitha, Sabyasachi Sengupta, Ravilla D Ravindran, Savitri Sharma, Joveeta Joseph, Vikas Ambiya, Taraprasad Das. A literature review and update on the incidence and microbiology spectrum of postcataract surgery endophthalmitis over past two decades in India. Indian J Ophthalmol.2017 Aug;65(8): 673–677.
- Malhotra S, Mandal P, Patanker G, Agrawal D. Clinical profile and visual outcome in cluster endophthalmitis following cataractsurgery in central India. Indian J Ophthalmol 2008;56:157-8.
- AIOS Guidelines to prevent intraocular infections. August 2018.
- Verma L, Gupta S, Tewari HK, Talwar D, Gupta A. Cluster endophthalmitis. DOS Times 2008;14:31-3.
- Atul Kumar,Dheepak M Sundar,andVineet Mutha. Commentary: The changing scenario of cluster endophthalmitisIndian J Ophthalmol. 2018 Aug; 66(8): 1079.