11/16/2014 01:37 pm ET Updated Dec 06, 2017

The India Sterilization Tragedy; Highlighting the Need for Better Choices, Safer Procedures

Co-Authored by Prashant Yadav, PhD*

Earlier this week 13 women died in Chhattisgarh in central India. They died after undergoing sterilization in a high-volume, low-cost "mass production" type campaign commonly termed "surgical camp." The media outrage over this has been astounding both in Indian and Western media. The New York Times calls this the highest death toll from a sterilization campaign. The cause of the deaths has not been officially confirmed, but observers say the women showed signs of toxic shock pointing to infected or unsterilized surgical equipment as a possible contributor to their death. Even if tainted medicine turns out to be the cause, this episode should focus us on the importance of sterile procedures.

Given the highly controversial past of India's family planning program, it is only natural that this incident draws strong reactions from civil society and women's rights groups across the world. Since independence in 1947, the Indian government has run one of the world's largest family planning programs. In its early days from 1960s to mid-1970s the Indian family planning program employed a combination of coercion and financial incentives. In mid 1970s constitutional rights and other freedoms were suspended under a state of Emergency. During this period, men were forcibly sterilized in vasectomy camps and tubal ligations were performed on women in "camps" without fully informing them about the risks and irreversibility of the procedure. Apart from the coercive measures, the strong financial incentives used for contraception have also been critiqued. Poor men were offered up to one month's salary and a portable radio for accepting to undergo a vasectomy. Targets set for healthcare workers also indirectly contributed to coercive measures.

The women who died in this tragedy were paid the equivalent of $10 as an incentive for elective sterilization. Some argue that small cash incentivizes like this force poor men and women who live in extreme poverty to submit to sterilization, too often in the risky conditions of "sterilization camps." India's number of female sterilizations as a percentage of all forms of contraception used continues to be the highest in the world. Some advocates of India's Family Planning program argue that this program has shown the world how to carry out contraception at large scale in low-cost settings.

There is no question that providing greater choice and improved access to modern contraceptives should become a larger component of India's health and gender equality program. Informing its citizens about the benefits of family planning and replacing crude and coercive surgeries with access to a range of modern reproductive health choices should be an important part not only of the health strategy but of India's overall development strategy. The use of targets and incentives for healthcare workers and end users of contraceptives is not necessarily bad. If designed well and provided for a range of contraception options, such programs can achieve good family planning outcomes without putting lives at risk.

Beyond outrage over the methods used to recruit women for sterilization procedures, the other major issue exposed by this tragedy is that the sterilization center was being run like an "assembly line." India has succeeded in building a reputation for its high-volume, low-cost healthcare delivery models. Yet the broad brushstroke critique of this model that has followed the Chhattisgarh tragedy suggests that the media is on the verge of declaring that approach a failure.

That need not be the case. Narayana Hrudalaya, founded by cardiac surgeon Dr. Devi Shetty performs over 30 cardiac surgeries a day - more than twice the number at Cleveland Clinic - at about 2 percent of the average cost for cardiac surgery in the US, and with health outcomes no worse than the best US hospitals. Their success depends on high patient volumes, a strong focus on efficiency, and streamlined processes. The Aravind healthcare system is the largest provider of cataract/ophthalmological services in the world. It performs over 350,000 eye surgeries each year with a surgical complication rate lower than many hospitals around the world. Rigorous measurement, standardization of procedures, staff commitment, and willingness to innovate are the key drivers of their success. These examples demonstrate that if implemented carefully, high patient volume can drive cost savings and make surgical interventions more affordable for all. It is important to have streamlined and standardized processes, rigorous measurement, check lists, and to ensure strong staff commitment.

What baffles us is that there is very little attention being paid to a clear, immediate reason for the danger of these sterilization procedures - use of un-sterilized surgical equipment. The lack of readily available sterilization processes in developing countries, including India, is a major risk factor for post-surgical septic shock and other infections. In facilities in the developed world, all instruments are sterilized before any invasive procedure. This is a basic standard of care that has been taken for granted for over a century. Dipping instruments in disinfectant is not sterilization. Yet sterilization technology, which allowed surgical care to enter the modern era, has not progressed beyond the electricity-dependent autoclave that was invented over 150 years ago. Sterilization is still not feasible in any low-resource setting. Often, the hospital or clinic has an autoclave but lack of maintenance, repair, and fluctuating or total absence of power render it useless. Moreover, the autoclave's dependence on steam means that many modern medical devices are degraded by autoclave sterilization, rendering this old technology useless even in places with reliable electricity access. In high-income settings, these instruments can be shipped to a different facility where they are sterilized by expensive and explosive gases, but clearly there is no such recourse in the developing world. As a result, well-meaning physicians carry out surgery with equipment teeming with bacteria, viruses and other pathogens. Simple, power-independent solutions such as Eniware's portable sterilizer, which can provide fool-proof sterilization of a wide range of instrument materials even in the small off-grid hospitals, are needed to make high-volume surgeries safe and effective in low-resource environments.

Clearly, the problem is complex and multi-faceted. Improved access to modern contraceptives and greater choice in long term contraceptive use should be a top priority for India's family planning program. But simple solutions such as power-independent sterilization equipment for surgical instruments and check-lists for surgeons can provide the basic necessities of safe care.

*Prashant Yadav is Sr. Fellow and Director of Healthcare Research at the William Davidson Institute at the University of Michigan. He is also on the faculty at the Ross School of Business and the School of Public Health at the University of Michigan