Medico-Legal Aspects of Post-Operative Endophthalmitis
Lalit Verma, MD ; Shefali Gupta,MS
Centre for Sight & Indraprastha Apollo Hospital, New Delhi
email.com:lalitverma@yahoo.com
Endophthalmitis occurs in best of hands
in best of set ups.
Only people who do not get endophthalmitis
are those who do not operate
For endophthalmitis to occur what is required is a breach or a cut in integrity of ocular coats and introduction of microbial inoculum. We all know during intraocular surgery both of these happen. Inoculum means microbiological load resulting in endophthalmitis. Inoculum can be of various sizes and types. To measure size of the inoculum one can use the concept of colony forming unit (CFU). It is a measure of viable cells in which a colony represents an aggregate of cells derived from a single progenitor cell. CFU is used to determine the number of viable bacterial cells in a sample per mL. Hence, it tells the degree of contamination in samples of water, vegetables, soil or fruits, or the magnitude of the infection in humans and animals. It is different from the direct microscopic counts that includes both dead and living cells. Types of inoculum mean different types of microorganisms. Like for Staph. aureus if 19 colony forming units enter intravitreally or 50 colony forming units enter anterior chamber during surgery, endophthalmitis will occur. For Pseudomonas if only 5 colony forming units reach vitreous cavity or 197 colony forming units reach anterior chamber fulminant infection results.
Corneal incision is at least three times more potent than tunnel incision for causing endophthalmitis. This is a well substantiated fact that it is the valvular effect of the incision which keeps it isolated from the nuances of conjunctival flora. If there is a compromise in valvular effect there is a possibility that there is a suction effect and more inoculum can enter the eye and there are more chances of endophthalmitis.
Intra-ocular infection has always brought disrepute to the ophthalmologist and this problem is not only rampant at eye-camps but also in hospitals, which include the five star ones. Only surgeon who does not have endophthalmitis is the one who does not operate. The problem is general and it is not the surgeon who is to be blamed although he is responsible for surgery. Despite the best possible care, mishaps cannot always be avoided because the error in one link of the entire chain may sometimes result in a disaster.
But in the court of law if you have a misfortune of infection then how to save yourself?
- Record all findings including vision-including projection of rays, intraocular pressure, status of cornea, anterior chamber reaction, pupillary reaction, details of iris, IOL (if present) and fundus. Get B-Scan ultrasound done if fundus cannot be seen at all.
- Record them daily and keep a copy with you.
- Do not do telephonic treatment. e.g if patient calls up in the night and complains of pain, redness, watering and if you tell him to continue or add steroid drops, then this is asking for a disaster. That means that instead of giving telephonic treatment tell the patient to go to nearby ophthalmologist available and show to him.
- Patient who is on treatment for endophthalmitis, see him daily and always write on the prescription to report SOS. If patient is from far flung area write on his card or prescription slip that in case of any pain or redness or decreased vision or unusual symptoms report to nearest ophthalmologist and mention “do not ignore.”
- Even at the cost of ………… please document, document and document.
- When in doubt seek peer review, refer to retinal surgeon or hospital.
- Involve multiple people or hospitals to safeguard you.
Greatest malpractice risk associated with endophthalmitis- Analysis of claims show that liability arises from a delay in diagnosis or treatment, including a delay in referring the patient to a vitreo-retinal specialist.
To reduce the risk of delay in diagnosis-
- If the surgery was complicated and took a long time or required extensive instrumentation, you should have a higher index of suspicion for the development of endophthalmitis.
- Give all patients written discharge instructions stating the symptoms that warrant contacting you (blurred vision, red eye, pain, photophobia).
- Educate your staff members who handle telephone calls about the risk of endophthalmitis. Instruct them to schedule emergent appointments for such patients. Err on the side of patient safety when deciding to treat over the phone versus examining the patient.
To reduce the risk of delay in treatments-
- Document your decision making process in the medical record, especially when the patient calls with symptoms of a possible infection.
- Obtain a thorough interval history and perform and document the clinical examination. Note the presence and absence of signs of endophthalmitis (the cardinal sign is intraocular inflammation greater than expected for that point in the recovery process.)
- If in doubt, consult with and/or refer patients to a vitreo-retinal specialist for management.
Measures to take to reduce liability:
- During the informed consent discussion ( a must for all surgeries), warn patients about the risk of infection and possibility of vision loss. Emphasize the risk specially if the patient has diabetes or is immunosuppressed. You have to tell the patient and relatives that you are going to do the best and leave no stone unturned in this regard – but still complications including infection happen in the best of hands and in best of set ups including in all developed countries.Explain in raw language- where ever there is a cut ( however small it may be ), bacteria or other organisms can enter.
- Have a prudent follow up plan, especially in the symptomatic patient, and ensure that the patients make the appointment before leaving your office.
- Diligently follow up on all the patients who miss or cancel appointments, again ensuring that they understand that not receiving appropriate treatment could result in blindness.
- Carefully instruct patients to call you immediately if vision loss, pain or other ocular symptoms develop before their next scheduled visit.
- Make sure to DOCUMENT, DOCUMENT, DOCUMENT.
- Take anterior segment and fundus photographs, if possible.
After the catastrophe in Khujra, practically a National Alarm was created and Supreme Court intervened & passed certain guidelines for eye camps:
1) Qualified, experienced ophthalmic surgeons registered with Medical Council of India or any State Medical Council should only perform the operations. Camps should not be used as training ground for post-graduate students, and operative work should not be entrusted to post-graduate students.
View point: Students or fellows or inexperienced doctors should operate under guidance and avoid doing surgery in one eyed and other high risk patients.
2) There should be a pathologist to examine urine, blood, sugar etc.
3) It is preferable to have a dentist to check the teeth for sepsis and a physician for general medical check-up.
View point: Physical presence of pathologist is not essential. What is required is a proper work up of patients, proper preoperative evaluation, and clearance from physician or cardiologist if needed.
4)All medicines to be used should be of standard quality duly verified by the doctor in-charge of the camp.
View point: This is of utmost importance especially so, for irrigating fluids, viscoelastics, sutures, intraocular lenses etc.
5)The necessity of maintenance of the highest standards of aseptic and sterile conditions at places where ophthalmic surgery - or any surgery – will be conducted was emphasised. The Supreme Court said: “The necessity of maintenance of the highest standards of aseptic and sterile conditions at places where ophthalmic surgery - or any surgery - is conducted cannot be over-emphasised.
View point : It is not merely on the formulation of the theoretical standards but really on the professional commitment, with which these are implemented, followed and periodically reviewed and appropriate action taken, that the ultimate result rests.
Remember, a surgeon is best known or assessed by the way he handles complications or unusual situations. The way he talks to the patient, his relatives is of paramount importance. All the problems arise when patient`s expectations are sky high and he is not explained the reality by the treating surgeon and someone else tells, makes the patient aware or even instigates ( not a uncommon situation )
