Sponsored by

for VH2O2 biological indicators cleared for use in the U.S. The FDA is the high- est authority in the U.S. (not the sterilizer manufacturer) on the final decision on which biological indicators are cleared as compatible (safe and effective) for use in vaporized hydrogen peroxide sterilizers for healthcare facilities. Many users were unaware that there is NO requirement for a sterilizer manufacturer to validate nor endorse indicators designed to monitor their sterilizers. The decision regarding the safety and efficacy of sterilization monitors is addressed by the U.S. FDA’s review and clearance procedures. There are many examples of monitoring products from multiple manufacturers being used to monitor steam, EO, and VH2O2 sterilizers.


Recently we have observed a change in culture, a wide-reaching shift in our prac- tices and procedures, and discovered some noteworthy best practices, and found some common themes amongst VH2O2 users that have helped improve their VH2O2 processing practices and procedures. The observed culture change has required some relearning of a few VH2O2 practices and procedures but will ultimately help us collaboratively meet our common goal of striving for the highest level of patient safety. HPN


1. Block Seymour, Peroxygen Compounds. Disinfection, Sterilization, and Preservation, Seymour Block, 5th edition, 2001, Chapter 9.

2. Schildknecht, H.; Holoubek, K. (1961). “The bombardier bee- tle and its chemical explosion”. Angewandte Chemie. 73: 1—7.

3. U.S Patent 6,528,016 B1 March 4th 2003 Kohler et al. 4. U.S Patent 6,875,399 B2 April 5th 2005 McVey 5. STERIS Document# M3644EN2012-10, Rev. B


7. FDA 510(k) K160818 _ STERRAD NX Sterilizer with ALL- Clear™ Technology

8. FDA 510(k) K160903_ STERRAD 100NX Sterilizer with ALLClear™ Technology

9. FDA 510(k) K172754_V-PRO maX 2 Low Temperature Sterilization System

10. STERIZONE VP4 Low Temperature Sterilizer Brochure 04/2018

11. Robinson, Nancy and Eveland, Randall. Using HPG steriliza- tion for heat-sensitive devices HPN January 2015

12. Chemical sterilization and high-level disinfection in health care facilities ANSI/AAMI ST58:2013

13. 2018 Edition AORN Guidelines for Perioperative Practice. AORN Inc.

Larry Talapa is a Microbi- ologist with over 25 years of experience in the area of sterilization and is cur- rently a Technical Service Specialist in 3M’s Medical Solutions Division.


Continuing eduCation test • deCember 2018 Collaborating a culture change

Relearning vaporized hydrogen peroxide sterilization Circle the one correct answer:

1. H2 O2 A. True

is found naturally in animals and plants. B. False

2. Technique sensitive is a term to describe variability introduced by the VH2O2 sterilizer operator that can have a significant impact on the outcome of the VH2O2 sterilization process. A. True

B. False

3. VH2O2 sterilant concentration during exposure is unchanging. A. True

B. False

4. There are 8 different VH2O2 sterilization cycles on the U.S. Market. A. True

B. False

5. VH2O2 sterilization cycles have loading weight limits. A. True

B. False

6. Residual moisture on devices have no effect on the VH2O2 sterilization process. A. True

B. False

7. Best practice is to limit the use of extra or nonessential materials in VH2O2 sterilization . A. True

B. False

8. AAMI ST58 states: “A PCD with the appropriate BI should also be used at least daily, but preferably in every sterilization cycle” . A. True

B. False

9. Improper loading of the sterilizer may result in cycle cancellations and/or positive biological indica- tor results. A. True

B. False

10. There is no requirement for a sterilizer manufacturer to validate nor endorse indicators designed to monitor their sterilizers. A. True

B. False

Request for Scoring o I have enclosed the scoring fee of $10 for EACH test taken — Payable to Healthcare Purchasing News. We regret that no refunds can be given. (It is not neccessary to submit multiple tests separately.)

Detach exam and return to: Continuing Education Division Healthcare Purchasing News 2477 Stickney Point Road, Suite 315B Sarasota, FL 34231

PH: 941-927-9345 Fax: 941-927-9588

Please print or type. Return this page only. Name Title

Hospital Name Mailing Address Apt/Suite

City, State, Zip Daytime Phone Email • HEALTHCARE PURCHASING NEWS • December 2018 33

The approval number for this lesson is 3M-HPN 180611.

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