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Jul-Sep2004-12(3)
ARTICLE
Ensuring quality of care in
sterilisation services
Abhijit Das
Abhijit Das
Female sterilisation is the mainstay of
contraceptive methods in India. Every year over four million female
sterilisation operations are conducted in the country. Like all surgical
procedures, female sterilisation, despite being a relatively low-risk procedure,
has its attendant risk and failure rates. According to international authorites,
the failure rate, i.e. the chance of becoming pregnant after the operation is
around one in 200, the rate of complication around one in 100 (1), and the risk
of death around three in 100,000 procedures (2). According to these estimates,
there is a possibility of over 20,000 failures, 20,000 women with complications
and about 150 deaths due to these operations. However, there are no specific
provisions for dealing with these acceptable risks within the
programme.
Healthwatch UP Bihar is an advocacy network on
women's health and rights in four states-Uttar Pradesh, Bihar, Uttranchal and
Jharkhand-which originally comprised UP and Bihar. Healthwatch UP Bihar is
actively involved in tracking the changes in the delivery of the state family
planning programme after the adoption of the Target Free Approach and after the
Reproductive and Child Health Programme (3). The state unveiled its population
policy in July 2000 and this policy had a set of escalating annual targets that
ranged from 600,000 to 1.2 million cases per year. While reviewing the policy
directives, members of the network came across a large number of cases of
sterilisation failures, complications and deaths (4). Site visits to
sterilisation camps revealed that bicycle pumps were being used to introduce air
into the abdomen for laparoscopic ligation (5).
Public interest litigation for ensuring
quality of care in sterilisation services
The Department of Family Welfare of the Government of India had prepared a manual of standards in the case of female and male sterilisation (6). The quality of care in 10 sterilisation camps was documented using these standards. It revealed that most of the standards were not being followed. The average operating time was between two and five minutes for laparoscopic ligation. Against the prescribed limit of 20 operations per team per day, teams were found to perform 75 operations.
The Department of Family Welfare of the Government of India had prepared a manual of standards in the case of female and male sterilisation (6). The quality of care in 10 sterilisation camps was documented using these standards. It revealed that most of the standards were not being followed. The average operating time was between two and five minutes for laparoscopic ligation. Against the prescribed limit of 20 operations per team per day, teams were found to perform 75 operations.
Using the Healthwatch UP Bihar and another study as
evidence, and the Department of Family Welfare guidelines as the basis, a public
interest litigation (PIL) was filed in the Supreme Court by Healthwatch UP Bihar
under Article 32 of the Constitution. The PIL (Writ Petition (Civil) No 209
2003) was admitted and the Supreme Court asked all states and union territories
to file their affidavits. The Supreme Court gave its order to states in May 2003
and since then only seven states and union territories have filed their
affidavits. These include Daman and Diu, Dadra and Nagar Haveli, Andaman and
Nicobar islands, Sikkim, Manipur, Haryana and Orissa. Except for Haryana, none
among these have acknowledged that there are any cases of failure, complication
or death and have solemnly sworn that all procedures are following the
standards. Haryana has been the sole exception because of the well-known Santara
case (7) where the government had to pay compensation for the failure of a case
of tubectomy.
It is interesting to note that a performance audit
by the Comptroller and Auditor General (CAG) on the National Family Wefare
Programme in 2001 reported that nine states had reported 762 failures and no
investigations had been carried out to establish the reasons for the failure. A
five-district study in Uttar Pradesh conducted in 1999 had reported a
failure rate of 4.7% which would amount to over 15,000 failures in that state
alone (8).
Quality of care, ethics and law in the case
of sterilisation
Sterilisation campaigns have been in the centre of controversies. Forced sterilisations in Nazi Germany, in the US in the early 1940s and the Sterilisation Act of Sweden are well-known cases of human rights violations. There were forced sterilisations during the Emergency in India too. However, after the International Conference on Population and Development (Cairo 1994), family planning programmes have supposedly become more development-centred and women friendly. India too has changed its policies and programmes through the adoption of the National Population Policy (NPP 2000), the Reproductive and Child Health Programme (1997) and the Community Needs Assessment Approach (1999). In the wake of these changes, the findings of the two studies raise a number of legal and ethical questions regarding the conduct of individual operations, mass sterilisation camps as well as programme design and accountability.
Sterilisation campaigns have been in the centre of controversies. Forced sterilisations in Nazi Germany, in the US in the early 1940s and the Sterilisation Act of Sweden are well-known cases of human rights violations. There were forced sterilisations during the Emergency in India too. However, after the International Conference on Population and Development (Cairo 1994), family planning programmes have supposedly become more development-centred and women friendly. India too has changed its policies and programmes through the adoption of the National Population Policy (NPP 2000), the Reproductive and Child Health Programme (1997) and the Community Needs Assessment Approach (1999). In the wake of these changes, the findings of the two studies raise a number of legal and ethical questions regarding the conduct of individual operations, mass sterilisation camps as well as programme design and accountability.
There are close relationships between quality of
care, ethics and legality. While quality of care can be considered to relate to
technical aspects, ethics relate to the moral responsibility and law binds with
legal accountability.
Sterilisation operations are non-therapeutic
procedures and therefore warrant extra care and caution (9) . The ethical
responsibility of the practitioner is more in the case of non-therapeutic
operations because it is possible to cause harm to someone who did not have a
problem to start with. Many women undergo tubectomy as a result of the subtle
pressures of health workers and the absence of knowledge and access to other
services. The ethical considerations in the case of female sterilisation have
more than one dimension. First, one has to consider the manner in which women
are recruited for the procedure. While this is the responsibility of paramedics
and outreach workers, it is finally the responsibility of the team headed by the
operating surgeon to ensure that all medical eligibility criteria and ethical
(informed consent) requirements have been met. The operating surgeons must
ensure that the minimum acceptable technical standards are met. Besides, women
who come to camps deserve to be treated with dignity. The author's experience at
the camps shows that a heavily sedated woman is picked up roughly and dumped on
the operation table. In the operation theatre, there is little concern for the
woman's privacy and at the end of the operation she is picked up and dumped
outside equally unceremoniously with little concern for post-operative care. As
a programme of high national priority, the family planning programme owes the
women who agree to undergo sterilisation operation, minimum respect and quality
services and medical personnel associated with these camps need to ensure
this.
Doctors often justify the shoddy treatment of women
at sterilisation camps by referring to the pressure of targets that they have to
fulfil or the lack of time. This is a dilemma that doctors must resolve at the
personal level as well as through professional organisations such as the Indian
Medical Association and Federation of Obstetrician and Gynaecologists Societies
in India. The accountability to the employer (the government) in terms of the
various pressures has to be balanced against the ethical responsibility towards
the individual patient. Besides ethical principles, the consequences of poorly
conducted operations have legal dimensions as well. Indian courts have admitted
cases of tubectomy failure and deaths and have taken steps to compensate women
both for medical negligence and fixed accountability of the state for negligence
of the doctor in cases of failure (7) as well as tubectomy deaths
(10).
It is time that the simple tubectomy operation is
examined more closely not only because it is perhaps the most widely conducted
surgical procedure in India but also because this major surgical procedure, if
improperly performed, has the potential to cause harm.
References
1. Rotimi AK, Eedarapalli P. Female Sterilisation. Available from URL:http://www.sexualhealthmatters.
com/v2iss2/article4.html (accessed on June 18, 2004).
2. Chapron C, Querleu D, Bruhat MA, et al. Surgical complications of diagnostic and operative gynae-cological laparoscopy: a series of 29,966 cases. Hum Reprod 1998;13:867-72.
3. Healthwatch UP Bihar. Voices from the ground. Lucknow: Healthwatch UP Bihar, 1999.
4. Healthwatch UP Bihar. Priorities of the People. Lucknow: Healthwatch UP Bihar, 2002.
5. Saxena R. Theatre of the absurd. The Week, 22 December 2002.
6. Ministry of Health and Family Welfare. Standards for male and female sterilisation. Division of Research Studies & Standards, Department of Family Welfare, MOHFW, Government of India, 1999.
7. Supreme Court in State of Haryana v. Santra [(2000) 5 Supreme Court Cases 182].
8. State Innovations for Family Planning Services Agency (SIFPSA). Laparoscopy Sterilisation: a study of success rate in the state of Uttar Pradesh. Lucknow, UP: SIFPSA, 1999 (mimeo).
9. Margaret AS. Therapeutic and non-therapeutic medical procedures-what are the distinctions? Health Law in Canada 1981;2:85-90.
10. Achutrao Haribhau Khodwa v. State of Maharashtra, 1996 Acc CJ 505 : (AIR 1996 SCW919)
1. Rotimi AK, Eedarapalli P. Female Sterilisation. Available from URL:http://www.sexualhealthmatters.
com/v2iss2/article4.html (accessed on June 18, 2004).
2. Chapron C, Querleu D, Bruhat MA, et al. Surgical complications of diagnostic and operative gynae-cological laparoscopy: a series of 29,966 cases. Hum Reprod 1998;13:867-72.
3. Healthwatch UP Bihar. Voices from the ground. Lucknow: Healthwatch UP Bihar, 1999.
4. Healthwatch UP Bihar. Priorities of the People. Lucknow: Healthwatch UP Bihar, 2002.
5. Saxena R. Theatre of the absurd. The Week, 22 December 2002.
6. Ministry of Health and Family Welfare. Standards for male and female sterilisation. Division of Research Studies & Standards, Department of Family Welfare, MOHFW, Government of India, 1999.
7. Supreme Court in State of Haryana v. Santra [(2000) 5 Supreme Court Cases 182].
8. State Innovations for Family Planning Services Agency (SIFPSA). Laparoscopy Sterilisation: a study of success rate in the state of Uttar Pradesh. Lucknow, UP: SIFPSA, 1999 (mimeo).
9. Margaret AS. Therapeutic and non-therapeutic medical procedures-what are the distinctions? Health Law in Canada 1981;2:85-90.
10. Achutrao Haribhau Khodwa v. State of Maharashtra, 1996 Acc CJ 505 : (AIR 1996 SCW919)
Abhijit Das, SAHAYOG, C-2015 Indira Nagar, Lucknow,
UP, India 226016. e-mail:abhijitdas@softhome.net