A physician-entrepreneur aims to make surgery safer in the developing world
Dr. James Bernstein '64, still has a note that Dr. Jonas Salk, gave him when he was managing his lab at the legendary researcher's institute in La Jolla, Calif. "It needs help to happen," the message says, "and you are one who has been ‘called.'" Dr. Salk, of course, is the physician-scientist who developed the first safe and effective polio vaccine, sparing untold millions from the crippling disease. That handwritten missive, Dr. Bernstein says, was a directive "to do some- thing really big that would have an impact on lots and lots of people."
Now Dr. Bernstein — a surgeon, internist and medical entrepreneur based in Washington, D.C. — is poised to follow his late mentor's advice. This spring, his company, dubbed Eniware, is launching a portable sterilizer that could save thousands of lives in developing nations where electricity is unreliable or non-existent and there is no practical way to sterilize surgical tools.
To understand the need for Eniware's device, Dr. Bernstein says, it's important to note that disinfection and sterilization are not the same: even when instruments are boiled or soaked in bleach for long periods, spores can survive. In refugee camps and field clinics — even in hospitals in impoverished nations — thousands die from post-operative infections, making relatively routine procedures like appendectomies and C-sections potentially life-threatening.
Louis Pasteur figured this difference out in the late 19th century, when he invented the autoclave. But autoclaves, which destroy microbes using technology similar to that of a pressure cooker, require large amounts of electricity and distilled water. What makes Eniware's sterilizer different, and potentially impactful, is its use of nitrogen dioxide (NO2) gas, which sterilizes at room temperature.The results of a feasibility study, which Eniware funded, were published in PLoS O in June 2015. It found that the technology "is well suited for low-resource environments and can sterilize challenging medical devices."
The Eniware device, called the Portable Sterilizer-25 Liter (PS-25), looks like big black suitcase with a knob on the top. The interior contains a rack that surgical instruments inside pouches, which have indicators confirming exposure to the sterilizer. A chamber for a NO2-generating cartridge releases the gas, which is removed at the end of each cycle by an internal scrubber before the unit can be opened. The rugged kit requires no other supplies, and no electricity, heat or water. The unit — which will be priced under $2,000 — can sterilize as many as a dozen instrument sets at once for less than $20. Dr. Bernstein says the device would typically be used 300 to 500 times, at an annual cost of under $5,000. "That is offset by the cost savings in avoiding the dire outcomes of surgery with unsterile instruments; the PS-25 compares favorably to disposable surgery kits, which can cost as much as $100 per set to use and dispose," he says. "We're using new technology that is portable and inexpensive to address a global problem."
— Franklin Crawford
This story first appeared in Weill Cornell Medicine, Vol. 15, No.2.