“The healthcare system in Sierra Leone is best described as desperate,” says Dr. James Bernstein, Co-Founder and CEO of Eniware, LLC. He’s chatting with me via Google Hangouts from Washington, D.C, where he’s recently returned after conducting an ease of use study for his product–the world’s first portable sterilizing kit for surgical instruments–in Freetown. “It’s been ravaged by ebola and civil war, and now without a functioning healthcare system there’s a lot of premature mortality.”
Worldwide, five billion people lack access to safe and affordable surgery, according to a 2015 study in The Lancet. That’s about two-thirds of the world’s population. In Sub-Saharan Africa, the study estimates that 93 percent of people cannot obtain basic surgical care. Even if they can obtain surgery, “safe” is the key word. Surgery performed with unsterile medical instruments often leads to infection, which can lead to death.
According to the World Health Organization, surgical site infections (SSI) threaten the lives of millions of patients each year and contribute to the spread of antibiotic resistance. Eleven percent of patients in low and middle income countries who undergo surgery are infected in the process. In wealthier countries, like the United States, SSI causes patients to spend more than 400,000 extra days in hospital at a cost of about $10 billion per year. In Africa, up to 20 percent of women who have a caesarean section end up with a wound infection. Another World Health Organization report lists operation-related issues as one of the main challenges preventing surgical site infection in Africa. Things like contaminated operating tools and poor hand washing technique can lead to high infection rates.
“Too many people are dying from common, treatable surgical conditions, such as appendicitis, obstructed labour and fractures,” said Lars Hagander, one of the lead authors of The Lancet study.
This kept Bernstein, a former surgeon who spent time working in Uganda, India, and Peru, up at night.
“Since 1970, there has been no innovation at all in the field of sterilization,” he says, “though the world situation has changed. In the developed world we have all these new, high-tech surgical instruments that cannot be autoclaved.”
The autoclave is the most popular sterilization mechanism. The original form–a high-pressure steam digester–was invented in 1679 by Denis Papin, but people soon realized anything exposed to high-pressure saturated steam could be sterilized. Charles Chamberland invented the first actual autoclave in 1884. About 20 years ago, Bernstein started a company called Noxilizer as a new way to sterilize medical instruments. It uses nitrogen dioxide, which is basically smog, as a sterilant. Once it was commercialized, he and co-founder and president Huma Malik, who previously worked on political and religious issues at the Center for Strategic and International Studies, set about trying to bring the technology to those who need it most.
“It’s why I went to medical school in the first place, to be a doctor in Africa or in South America and to take care of people,” Bernstein says. “And it became very clear to me very rapidly that in many parts of the world, you can’t sterilize medical instruments because there’s a lack of electricity.”
The Eniware Portable Sterilizer (EPS-25), a small version of the Noxilizer technology, doesn’t need electricity or water to work. During the Freetown visit, nurses showed Bernstein their autoclave, which was burnt and no longer effective. They were using boiling water in canisters to sterilize instruments, then removing them with tongs. Boiling water disinfects, but does not sterilize.
The EPS-25, which was a finalist in the Fast Company World Changing Ideas Awards, is lightweight, durable, safe, and effective. It doesn’t require energy, fuel, or water. The sterilizer comes with a disposable ampoule that generates nitrogen dioxide gas, and a disposable scrubber that absorbs the gas after sterilization is complete. Instruments are placed inside the sterilizer, along with chemical indicators that confirm the sterilant gas was released. Instruments can then be kept in the case until used, or used immediately. It works well in rural areas and hospitals without electricity or clean water around the world. In somewhere like Sierra Leone, which has the highest maternal mortality rate in the world, it could make a massive difference. So why is it so hard to get funding?
That’s a question that’s pressing for the Eniware team. “People think the U.S. is the way the rest of the world is. It’s not. It’s very hard to get financial support because people are unaware, or they’re not interested, or they just don’t care,” he says.
The EPS-25 has been completed and is on its way to becoming FDA and CE-mark approved. Now, Eniware is working on getting the price down to a level where it’s cheap and efficient, something that will require manufacturing on a larger scale. For this, the company needs investors. “Every day we don’t have the product available, somebody dies. I find it appalling,” Bernstein says. Still, he remains confident the product will be in use this year and available for medical facilities worldwide, military use, and humanitarian relief exercises.
Sterilization isn’t the end of the road, though. The next step for Bernstein is changing the way surgery is performed.
“If you look at the UN and the World Bank population forecast, by 2050 the population will be up by one billion people. You don’t buy babies on Amazon–you have to have them. That means there will have to be more than one billion births,” he says.
With those births inevitably come caesarean sections. Bernstein says the most conservative number of c-sections that will be done to prevent things like fistulas or premature mortality is around five percent. That means at least 50 million surgeries over the next 27 years. Even if sterilization is no longer an issue, there simply aren’t enough surgeons.
“The American model of creating surgeons takes years and years of school. How are you going to create millions of surgeons from that model? It won’t work. It will take local people trained to do surgery,” Bernstein says.
Instead of training to be a carpenter or a dressmaker, he argues people should be trained in basic surgeries, without having to go to medical school first. Medical schools in the United States currently have global health programs that send teams of students abroad to teach local surgeons, something Bernstein finds absurd and redundant.
“These are old fashioned, traditional barriers set up by professional organizations who want to keep out the competition. They’re not designed to promote excellence, but to keep people out,” he says. “But, it’s beginning to change, and that’s a good thing because the population numbers are just overwhelming.”
If changing the way sterilization works and surgeons are trained seems like a large, tiring task, you wouldn’t know it from speaking with Bernstein, who is in his 70s but endlessly energetic when discussing these issues.
“Of course we all want to make a difference, but what is the difference we’re going to make?” he asks. “You want to leverage so you impact millions and millions of people, not just one at a time. I like to think the EPS is going to make surgery available to millions and millions over 10 years. That’s tangible results. That’s why I do it.”
