Sterilization Deaths: Robbed of Choice and Dignity
Robbed of choice and dignity
THE CITIZEN brings to you a report prepared by a multi-organisation team---Poonam Muttreja, Population Foundation of India Alok Banerjee, Parivar Seva Sansthan Kalpana Apte, Family Planning Association of India Subha Sri, Common Health, in two parts.
The tragic death of 16 young women and the critical condition of several others following tubectomy at a sterilisation camp in Bilaspur District, Chhattisgarh has once again brought to fore the disregard for dignity of women and the dismal quality of care of India’s family planning programme. In recognition of the fact that violations of standard operating procedures and guidelines prescribed by the Ministry of Health and Family Welfare (MOHFW) are not limited to Bilaspur or Chhattisgarh, but are a grave concern across the country, a multi-organisational fact finding team travelled to Bilaspur on November 19-20, 2014 to assess the situation and recommend corrective actions at national and state levels.
The objective of the visit was to assess the situation that led to the deaths, and to make concrete recommendations so as to prevent such tragic deaths of women seeking family planning services.
Sequence of events:
On November 8 (Saturday), 2014 at Takhatpur Block in Sakri at Nemi Chand Jain hospital - 83 women underwent sterilisation through laparoscopic tubectomy. On November 10 (Monday), 2014, camps were organised in Gaurella block at three PHC sites— Gaurella, Marwahi and Pendra where 23, 16 & 15 women were operated respectively (total 54).
Post procedure all clients were given one strip each of an antibiotic - Ciprofloxacin 500 mg in capsules, and a pain reliever - Ibuprofen tablets with the instructions to consume one tablet of each medicine twice daily, once they got home.
As per the information provided by the officials some of the women started vomiting from Saturday night itself. The discomfort increased gradually and was then associated with burning in throat, pain in abdomen and breathing problems in some. These women first contacted their Mitanin (community health worker)&the ANM. Some of them were given an antiemetic drug, but when their vomiting did not stop, these women were taken to the district hospital where very low blood pressure was recorded for all of them.
To start with three women went to the district hospital on Sunday (November 9), out of whom two died. Subsequently, more women went to the district hospital on the same day with similar symptoms. Sensing the gravity of the situation, some women were shifted to CIMS4, a government-run tertiary care medical institute. Apollo hospital was also contacted for ICU support for women in critical condition. By Monday night and Tuesday (November 10 and 11) more women became seriously ill, and some more died due to irreversible shock.
The district administration took a quick decision on Monday evening to reach out to all women who had undergone sterilisation in the four camps and bring them in for a check up. Ambulances were sent to all villages and the ANMs and Mitanins along with the Patwaris and Rojgar Sahayaks brought the women to various hospitals. The government provided support and resources to increase the number of beds and Intensive Care Unit (ICU) facilities at Apollo hospital (additional 28 beds) along with their existing ICU facility to cater to serious patients needing intensive care.
Doctors treating the women at all the three hospitals (District Hospital, CIMS and Apollo) informed us that the symptoms and signs in all the women (who had taken Ciprofloxacin - both laproscopic sterilisation cases and few others who had throat/chest infection) were due to “some problem with the drugs”. However at Apollo hospital, a few cases showed raised levels of Pro calcitonin that suggest septicaemia (a life-threatening bacterial infection), and indicating that the women may have had an infection during or after their operation.
Discussion with the doctor who conducted the post mortem examination at CIMS & the District Hospital on the first seven death cases, revealed that there was evidence of peritonitis with fluid in peritoneal and pleural cavity, and septic foci in the lungs and kidneys, suggesting sepsis leading to septicaemia.
In an attempt to identify the cause of the deaths, the administration sought the list of drugs provided to the women post sterilisation in all four camps. Four drugs were common in the list – Diazepam, Ibuprofen and Ciprofloxacin, and Povidine Iodine for external application. Based on the symptoms seen in the affected women, they zeroed in on two drugs – Ibuprofen and Ciprofloxacin. Of these, the Ibuprofen tablets were manufactured in 2013 and were in circulation for some time, whereas the Ciprofloxacin was manufactured in October 2014. Samples of these drugs were sent to various laboratories in Raipur, Kolkata, Delhi, Pune and in some private laboratories for analysis. Preliminary testing confirmed the presence of some toxin in the samples of Ciprofloxacin. However, whether it was Zinc Phosphide as suspected by the doctors and whether lethal amounts were present in the drug, has yet to be established. Some doctors also observed that conditions such as renal (kidney) failure observed in certain women were not a reaction of Zinc Phosphide. Further, according to Forensic Medicine and Toxicology experts, an adult male needs to consume 5 gm of zinc phosphide to die. For average adult woman, this would be 4.5 gm. This, if consumed in one go or slowly over a period whereby it gets deposited in the body. The contaminated medicines were of 500 mg of the antibiotic. Even though it is impossible, but for the sake of argument if we assume that the entire 500 mg was zinc phosphide, a woman would need to consume a minimum of nine tablets to make the poison fatal, which was not the case with the women who died. So it is amply clear that zinc phosphide in the medicines could not have been the major cause of these deaths, even if we accept that they could have been one of the causes.
In total, 16 lives were lost in this catastrophe. However, it has to be acknowledged that due to quick action by the District Administration to admit all the women who had undergone sterilisation procedures on November 8 and 10, 2014, at the three hospitals for close monitoring of their condition and treatment, many more deaths were possibly averted. The District administration also continued monitoring all women through home visits by a medical team daily for one week following their discharge from the hospital. They will be further assessed with kidney function tests, ECG etc. after one week at the hospital.
The state government has given cheques of Rs. 4,00,000/- to the next kin of the deceased and fixed deposits of Rs. 2,00,000/- for each child in the family. In addition, free education and health care will be provided by the state for the children who lost their mothers.
2. Steps followed in Laparoscopic Sterilisation camp on November 8, 2014:
The chronology of actual steps followed during the camps as revealed from discussion with the health care providers involved at the Nemi Chand Jain Hospital camp on November 8, 2014, are as follows –
The staff involved in the camp were: Four medical officers including two MBBS doctors and two Registered Medical Assistants responsible for general screening of the women and their selection for the sterilisation procedure; Two Staff Nurses (from PHC-Amsena and Takhatpur) to assist in the Operation Theatre; Two ANMs (one each from PHC-Amsena and a nearby Sub Centre) to give pre-medication and inject local anaesthesia outside the OT; Two dressers(from PHC) to stitch the wound after the procedure; Two ward boys (from two PHCs) to bring the cases inside OT, position them on the OT table and shift them after the procedure. A number of ANMs and Mitanins from the field were also present at the hospital as motivators. The Laparoscopic surgeon came with one OT assistant.
If the protocols set by the Government of India were to be followed, for a camp with 83 clients three teams are required.
Each team would constitute of three staff in the Operating Room – one lapro surgeon; one OT assistant and one nurse. In addition, the local health centre should have two doctors (including one lady medical officer), four staff nurses, one ANM and two attendants would be required.
Women with two or more children were motivated to get sterilized mostly by local ANMs and Mitanins (ASHA), who also arranged to bring them to the camp sites. The transportation cost to the hospital and back in private vehicles was borne by the women themselves.
The women started coming in for registration in the camp from 10.30 am onwards till 1.30pm. All women were screened by the Registered Medical Assistants, and laboratory tests were done for haemoglobin levels and sugar in the urine. All women after check up were given pre-medication drugs at around 2pm by ANM and made to lie down on mattresses spread on the floor, as there were no beds at Nemi Chand Jain Hospital).To a query by the team about the fumigation procedures followed, the reply was, "Yes fumigation was done. The sweeper cleaned the walls with a mop."
In a running OT (such as in a CHC / District Hospital) fumigation is not recommended under infection prevention practices. The recommendation is mechanical cleaning of OT with plain water followed by swabbing of OT with 0.5% chlorine solution.
However, in case the OT is not in use for several weeks / months (as in the case of Nemi Chand Jain Hospital), or in the case of a new OT then the steps for fumigation practices are:
- Make fumes by burning formaldehyde tablets and seal all outlets. The OT has to be kept closed for 48hrs
- After 48hrs the OT has to be opened and then liquid ammonia should be burnt, then only is the fumigation practice complete.
The Laparoscopic Surgeon with his OT Assistant arrived at the venue around 3 pm (this was also corroborated by family members of the women present at the site) and started the sterilisation procedures at 3.30pm and continued till about 5 pm. A total of 83 women were thus operated in about one and a half hours, approximately one to one and a half minute per surgery. The prescribed standards would take an average of 5-6 min per case, with three laparoscopes. After each surgery the laparoscope has to be sterilized with high level disinfection which would take approx. 20 min (first swabbing with spirit for decontamination, then dipped in Cidex solution for 20 min, followed by immersing it in sterilized/ boiling water) for reuse.
Two operating tables were used inside the OT, which were positioned in 45degree angled Trendelenburg position5. Two nurses were stationed at the two tables and the Surgeon’s OT Assistant kept the Laparoscopic equipment in between the two tables.
Just outside the OT, probably on a bed/ floor mattress, local anaesthetic injection (Lignocaine) was administered by one ANM on the women prior to sending them inside the OT. The ward boy accompanied the women, and positioned them on the OT table.
The nurse cleaned the navel region of the abdomen with a spirit swab and put a draping sheet with a central hole. The incision around naval region is done by the OT Assistant/dressor; the Surgeon then introduces the Trochar6 inside the abdomen and then the Laparoscope7 with the Ring applicator together for tubal occlusion. Pneumoperitoneum (introduction of gas inside the abdomen) was not done except in three cases using atmospheric air (where difficulty was faced in identifying the tubes). After the tubal occlusion was done on both sides, the laparoscope was taken out and the wound stitched with cotton thread by the PHC dresser. The women were then shifted by the Ward boy on to the mattress placed on the floor in the corridor in front of the OT.
As per the information provided to the team, none of the staff changed their hand gloves in between the procedures. The same injection needle and syringe, and the suture needle were used for all the cases. Neither were those sterilized nor new needles taken for each case. The laparoscope after the procedure on each woman, was cleaned by dipping into a big tray containing warm water and betadine, and cleaning with a dry gauze piece before using in next case. Only one laparascope was used, while the Ministry of Health and Family Welfare (MoHFW) guidelines prescribe three for a maximum of 30 patients.
Through meticulously arranged duties for each staff member, the Surgeon performed each procedure without adhering to any degree of Infection Prevention practices and quality of care procedures. The Laparoscopic surgeon did not check any of the women before or after the procedure. After completing the cases, the Surgeon put his signature on the client’s case sheets and left.
All the women were kept in the hospital for half to one hour post procedure and then sent home with their motivators/relatives after a payment of Rs. 600/- as compensation money, as per the MoHFW compensation scheme. The post procedure check up was not done by any doctor or nurse. The post procedure instructions and drug packets were given by the ANM/Mitanin to the women once they reached home.Within 12 to 24 hours, a majority of the sterilized women developed complications manifested as repeated vomiting, burning in throat, pain in upper abdomen and giddiness, and also a rapid fall in blood pressure.
As informed by the officials at the District Hospital, the initial treatment started with IV fluid administration with 5% Glucose saline, antiemetic drug injection, vasopressor drugs8 like injection adrenaline and steroid Injection Hydrocortisone and oxygen inhalation. These medications could not control the crisis of shock and the women started developing pulmonary oedema (collection of fluid inside lungs). Because of this – IV fluid administration was restricted, and they were given more doses of Injection Hydrocortisone and Cortisone as also Diuretic Injections (Lasix) and a broad spectrum antibiotic (Injection Meropenem 1 gm IV).
Women in a critical condition were sent to CIMS and Apollo hospital at Bilaspur for advance life support and care. At the CIMS and Apollo hospital the women were treated with restricted & controlled IV Fluid infusion mainly with Ringer Lactate solution, Injection of Adrenaline & Nor adrenaline, Dopamine, steroids and broad spectrum antibiotics like Injection Vancomycin, Injection Meropenem and Metrogyl as well as oxygen. Majority of the women needed ICU care at both the hospitals and about 30 women were put on ventilator support to maintain their respiration. In 8 to 10 women, dialysis was also carried out, to manage acute renal failure.
No antidote or chelating agent was administered to any of the woman at the three hospitals.