Eniware Portable Sterilizer is a prototype that uses nitrogen dioxide to sterilize medical equipment without electricity to provide portable, power-free medical instrument sterilization for surgical care in any setting.
SDG 3: Good Health and Well-Being
Market Suggested Retail Price
Target Users (Target Impact Group)
Small and Medium-sized Enterprises, Public Sector Agencies, NGOs
Distributors / Implementing Organizations
The Essential Surgery Company is a collaboration between Eniware and Dr. Ian Clarke, CEO of International Medical Group, Uganda. The company is an implementer and distributor in Uganda that oversees the marketing and distribution of the PS-25 in East Africa. In addition, Pro-Health International and Johns Hopkins Medicine are implementation partners for a Nigeria Mission Camp study. Finally, Jhpiego is a partner for product development research, evaluation, and training. A full list of Eniware's distributors, implementers, and other partners can be found on the Eniware website.
Components are sourced from various vendors in USA, a partner company completes the assembly, and then the product is shipped from USA. The supply chain is in the planning process as of July 2016.Interview with representative Experts advise that manufacturers should be evaluated against Good Manufacturing Practices and have objective evidence of an effective Quality Management System.
Intellectural Property Type
User Provision Model
The product can be purchased by individual hospitals or non-profits by contacting Eniware on their website.
Distributions to Date Status
This product is not yet widely distributed (as of July 2016) but an ease of use study will occur in 2016, which will begin distribution.Interview with representative
4 consumables: ampule (generates NO2), scrubber (absorbs NO2 gas), up to 8 acids, and up to 8 chemical indicators. Total cost is $20 per set of disposables
Indispensable equipment for function (Y/N)
Maintenance or calibration required by user at time of use? (Y/N)
Method of sterilization
Nitrogen dioxide (NO2)
Power Supply Type
Battery-powered, will last 600 cycles
This product needs no external electricity because it is powered by 3 Alkaline C6 batteries, which last 600 cycles. No water is required. The capacity is 9 liters and the sterilizer weighs less than 1 kg. The sterilant is nitrogen dioxide. A video demonstration of the product is available on the Eniware website. Experts caution that a reliable and dependable source of gas in country is necessary and in the particular location where the product will be sited.
Technical support will be provided by the manufacturer and, in the future, local distributors.Interview with representative Experts advise that all medical device manufacturers must have the ability to collect customer complaints, evaluate them and address each of them.
Replacement components will be provided by the manufacturer and, in the future, distributors will be setup to supply them as well. The consumables that are replaced after each use include an ampule that generates NO2, a scrubber that absorbs NO2gas, and chemical indicators.Interview with representative Experts caution that in resource constrained environments the availability of these chemicals is limited. Additionally, piping, housings and containment of chemicals is required to support NO2 sterilization. These can be available if an appropriate supply chain is developed and maintained to provide these materials at the appropriate cost, quality and delivery to support production.
600 cycles or 1 year. The device uses 3 Alkaline C6 batteries, which will last 600 cycles.Interview with representative Experts note that all medical device manufacturers have the responsibility to support their products throughout their entire lifecycle (i.e. appropriate retirement and recycling is required.)
Manufacturer Specified Performance Parameters
Designer specified performance targets include: lightweight, durable, easy-to-use, safe, and effective for multiple uses.
Vetted Performance Status
Surgical equipment that is improperly sterilized may cause infection and other medical complications. More information about sterilization safety can be found in the William and David article.
Complementary Technical Systems
Academic Research and References
William, A., David, J., 2004, Disinfection and Sterilization in Health Care Facilities: What Clinicians Need to Know, Clinical Infectious Diseases, 39, pp. 702-709
Jack, E., Sterilization and care of surgical instruments and supplies, Journal of the American Academy of Dermatology, 11, pp. 381-392
William, A., 2016, Disinfection and Sterilization in Health Care Facilities, Infectious Disease Clinics, 30, pp. 609-637
Compliance with regulations
The product is in the process of obtaining CE Mark (as of July 2016), estimated to be received by end of 2016.Interview with representative
Video of TEDx talk from company CEO, James Bernstein.