Eniware Portable Sterilizer PS-25

Target SDGs

Market Suggested Retail Price

$2,000.00

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.

Competitive Landscape

Direct competitors include SteraMist, Sterilux Steribox and Control Station, and IES Medical Sterilization System.

Manufacturing/Building Method

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

Patent

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

Design Specifications

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.

Product Schematics

Technical Support

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

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.

Lifecycle

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

Unknown

Safety

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

None

Academic Research and References

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}

Evaluation methods

Unknown

Other Information

Video of TEDx talk from company CEO, James Bernstein.