Sterilux Steribox and Control Station
Africa, India. Source: Sterilux video
Control station price is $12,095 and SteriBox price is $310. A hospital would typically buy 1 control station and 15-30 Steribox, totaling $15,500-$21,700.^(Interview with representative)
Disposable equipment, disinfection with boiling water or chemical treatment (hydrogen peroxide plasma, formaldehyde). More information on disinfection vs. sterilization can be found here.
Sterile practician technicians; medical professionals
As of July 2016, the first 10 products are planned for manufacturing and distribution by the end of 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.
The product is not widely distributed as of July 2016. The first field test will happen by 2017 and the first sales by 2018.^(Interview with representative)
The Control Station generates ultraviolet light (UV), which creates the sterilizing agent (ozone) from the oxygen present in the air. Software is included to execute the complete sterilization process. The SteriBox ensures the sterile barrier. This system needs 10 minutes of electricity/cycle or can be battery-powered for up to 100 cycles. Experts emphasize that a reliable source of power or electrical storage and/or backup power is required. 1mL of drinkable or non-drinkable water is needed per cycle. This video demonstration is available on the Sterilux website.
Control station design specifications: Dimensions: 40 cm x 30 cm x 45 cm 15.7 in x 11.8 in x 17.7 in Weight: 10 Kg, 22 lb Power: 100 W Voltage: 110 / 230 V Frequency: 50/60 Hz Battery life: 100 cycles Shelf life in number of cycle: 20,000 Capacity: 10 cycles per hour Wavelengths: 185 nm and 254 nm
SteriBox design specifications: Dimensions: 62 cm x 30 cm x 17 cm 24.4 in x 11.8 in x 6.7 in Bigger and Smaller boxes will also be made. Weight: 0.5 Kg, 1.10 lb Material: HDPE Capacity: 30 liters, 7.9 US gal lqd Storage maximal period: 3 months
Unknown. Experts advise that all medical device manufacturers must have the ability to collect customer complaints, evaluate them and address each of them.
Control Station : 10,000 sterilization cycles. 5 years. SteriBox : 1,000 cycles. 3 years.^(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.)
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. The Sterilux website describes that no toxic components are created by the system because the product uses ambient air to temporarily induce ozone, but the gas is then destroyed and the air returns to its initial composition at the end of the sterilization cycle.
The SteriBox and Control Station are complimentary systems. Other complimentary technical systems include consumables such as a blue indicator sticker and printed label (associated cost of <50 cents US/cycle).
Experts note that UV technology requires a source of UV (which may be difficult to access in remote areas as the availability of UV hardware is limited). Other components such as housings, covers, electronics and controls are available if an appropriate supply chain is developed and maintained to provide these materials at the appropriate cost, quality and delivery to support production. No special piping or chemicals are required to support UV sterilization.
None^(Interview with representative)
As of July 2016, Sterilux plans to submit an application for CE mark in early 2017.^(Interview with representative)
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