STERIS Corporation - Helping to provide a healthier today and a safer tomorrow.

 

 

 
 

Proven Safety Performance

At STERIS, safety is at the forefront of everything we do. We strive to provide safe, effective, quality products and services. We take our responsibility for public health and the safety of patients and providers very seriously and are committed to compliance with established legal, regulatory and ethical standards.

STERIS recognizes the importance of safety and recommends compliance with applicable standards and guidelines, designed to keep you safe. V-PRO® Sterilizers are designed with numerous safety features, and STERIS considers established OSHA and AAMI Standards in developing our IFUs and making safety recommendations.

Below are the safety features we've developed to protect you and your patients.

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Safety Features of V-PRO Sterilizers

 

  • No toxic process residuals remain on devices post-processing in a V-PRO Sterilizer. 
  • STERIS has demonstrated through testing, including user testing, that hydrogen peroxide vapor levels surrounding V-PRO Sterilizers are safe and well below OSHA established time weighted average (TWA) of 1 ppm (1.4 mg/m3) over 8 hours.
  • The exhaust system design ensures the hydrogen peroxide gas passes through a catalytic converter as the first step in the process. This helps to prevent the remainder of the exhaust system from being exposed to the hydrogen peroxide gas and therefore minimizing damage and subsequent leaks or odors.
  • The control prompts the user to confirm that the current load matches the cycle selected to assure sterile efficacy.
  • Cycle tape and control screen clearly document when a cycle has successfully completed or aborted ensuring only correctly processed loads are used when needed.
  • The simple chamber design, free of coils and sensors, makes it easy for shelves to be pulled out. This helps avoid tears and rips in the delicate packaging and potentially delayed surgeries.
  • Oil lamp indicators on the control screen provide an easy-to-interpret reminder to schedule preventive maintenance and reduce the possibility of oil misting or odors. This ensures that your equipment is operating and performing optimally when you need it the most.
  • Leak tests, similar to those for autoclaves, evaluate if air is leaking into the chamber. This built-in safety measure is a predictive maintenance method, and helps to ensure optimal performance.

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Vaprox HC Sterilant

 

  • The VAPROX® HC Sterilant cup is engineered for easy handling and to prevent accidental spillage. Under normal conditions of use, the VAPROX HC Sterilant cup, containing 59% hydrogen peroxide, is sealed and the sterilant cannot be accessed without physically damaging the cup.
  • Once placed in the unit, the sterilant cup interface door remains locked until the cup is empty.
  • AAMI ST58:2013 provides that personnel should always wear appropriate personal protective equipment (PPE) when using hydrogen peroxide gas sterilizers. Therefore, wearing PPE, such as chemical resistant gloves when handling a VAPROX HC Sterilant Cup, is recommended for maintaining compliance in accordance with AAMI ST58:2013. To recommend otherwise would be recommending nonconformance to national standards.

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General Safety

 

  • Eyewash Stations: OSHA and AAMI ST58:2013 (See Section 4) requires that eyewash stations must be available for immediate emergency use in all places where chemicals are used. STERIS requires eye wash stations in accordance with these recognized standards and guidelines.
  • Personal Protective Equipment (PPE): AAMI ST58:2013 (Appendix H.4.1.1) states that personnel should always wear appropriate PPE when using hydrogen peroxide gas sterilizers. STERIS recommends wearing gloves when working with the V-PRO Sterilizers, in accordance with the AAMI guidelines.
  • Air Exchanges: In accordance with AAMI guidelines for SPD design, STERIS recommends that unit be installed in the location with 10 air exchanges per hour.
  • Cleaning the Sterilizer: STERIS recommends cleaning sterilizers in accordance with AAMI housekeeping procedures. Blue lint, label sticks, and other debris accumulate on many surfaces in the SPD, including the sterilizer and its chamber.
  • For additional information on the safety of the V-PRO Sterilizers, you can refer to the Technical Data Monograph. This document summarizes all the testing that STERIS has performed on the V-PRO Sterilizers for microbiocidal efficacy, material compatibility, biocompatibility testing and safety.