Eniware Portable Sterilizer PS-25
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.
East Africa^(Interview with representative)
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.
$2000.00 for the device, $20 for consumables in each use^(Interview with representative)
Sterile practician technicians; medical professionalsInterview with representative
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.
Product can be purchased by individual hospitals or non-profits by contacting Eniware on their website
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
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.)
MET LabsInterview with representative
Surgical equipment that is improperly sterilized may cause infection and other medical complications. More information about sterilization safety can be found in this article by Rutala and Weber.
NoneInterview with representative
Trilling et al Nitrogen Dioxide Sterilization in Low-Resource Environments: A Feasibility Study PLoS ONE, 10.6 (2015)
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
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