Updated on February 16, 2024

·

Created on May 23, 2016

Eniware Portable Sterilizer PS-25

Upcoming Update

Eniware Portable Sterilizer is a portable, power-free medical instrument sterilization for surgical care in any setting.

Developed By
  1. Eniware
Content Partners
Unknown

Author

Product Description

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.

Target SDGs

SDG 3: Good Health and Well-Being

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

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

Capacity (Liters)

9

Consumables

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)

N

Maintenance or calibration required by user at time of use? (Y/N)

N

Method of sterilization

Nitrogen dioxide (NO2)

Power Supply Type

Battery-powered, will last 600 cycles

Water required

None

Weight (kg)

<1

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

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

Evaluation methods

Unknown

Other Information

Video of TEDx talk from company CEO, James Bernstein.

Comments from the Community

2 Comments

  1. Jeremy Schonhorn says:

    Overall, the technology approach is sound. Measurement of liver enzymes (AST/ALT) is a standard approach to a physicians understanding of liver function. Changes in liver enzyme level in response to medication or infection can aid in the guidance of patient treatment.The ability to deliver a tool that is stable and usable with little powered equipment and finger stick whole blood has great appeal, especially for use in remote settings.

    DFA needs to address the broad usability of their read guide. Different readers will interpret the guide (and enzyme level) differently. Additionally, enzyme kinetics will vary as a function of temperature. It is unclear how the DFA approach deals with environmental variables. That is, are there different guides or assay timing based on temperature level.

  2. Kelley Elahi says:

    Was the clinical study in Lilongwe published academic research?

Leave a Reply

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