Industry

Competitive Overview

In today’s hospitals, sterile reprocessing is common in three areas: the Central Sterile Department (CS), the sub-sterile area of the Operating Room (OR) and the Gastroenterology Department (GI).

Sterile Reprocessing Areas

Sterilization Areas in Hospitals

The low-temperature gas sterilization methods most commonly used today are Ethylene Oxide (EtO) and Hydrogen Peroxide (H2O2) systems. Both of these methods offer “terminal sterilization”, which refers to instruments that are packaged and remain sterile until opened at the surgical site. However, EtO is a toxic gas that requires aeration time for desorption of the chemistry, and this keeps an expensive stock of medical devices captive for periods of 16 to 30 hours. H2O2, on the other hand, is fast but expensive, given its limitations in efficacy and loading capacity.

Another method that plays an important role within a subsegment of low-temperature sterilization is Liquid Chemical Sterilization. This type of process is located directly in the OR as a just-in-time method to complement the CS Department’s sterile production. The GI Department is also a heavy user of Liquid Chemical Sterilization. Liquid systems are not terminal and instruments require rinsing with extensively treated water that cannot be assured as sterile. Consequently, instruments cleaned with Liquid Chemical Sterilization are not guaranteed to be sterile when used on a patient.

Each of these alternate sterilization products offers benefits to customers, but neither is a complete solution that meets the need for high-volume, cost-effective throughput of complex and expensive medical devices. Until now, customers have had to purchase and support a combination of products to meet their daily requirements for sterile supplies.