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  • Performance Qualification (PQ): The Proof

    This is the final article on the subject of process equipment qualification. As a reminder, we qualify process equipment to ensure: The equipment is what was ordered The utilities are sufficient The cycles run as expected The cycles run really do what you need them to do This last point is the subject of

  • Sterile Storage, Inventory Control, and Ensuring Items Are Delivered to the Point of Use Intact

    One of the things I get to do for a living is to audit sterile processing department and perioperative sites for good practices. One of the things I do for free is participate in the Kilmer Innovations in Packaging – Last 100 Yards working group, a group that is developing support documents that will, hopefully,

  • The Nuts and Bolts of a Quality System: What Is This Machine and How Do I Know What to Expect of It?

    “Uncontrolled variation is the enemy of quality.”—W. Edwards Deming For more than 30 years, industry has been trying to improve the quality of their products and services, and when they meet certain criteria from independent auditors, throwing terms about like ISO 9000, ISO 9001, ISO 13485, cGMP, QSR, and more. What do all of these

  • Reprocessing of Single-Use Items (You Know, Masks)

    There are issues surrounding the processing of N95 and other masks in vaporized hydrogen peroxide (VH2O2) sterilization, which is what is being done in most hospitals. Hydrogen peroxide is referred to as H2O2. Subjects to be covered are: Why are these (normally) single-use devices? What are the differences between doing this in STERRAD and STERIS

  • Dichotomy: If It’s Not One Thing, It Must Be the Other

    “When you come to a fork in the road, take it.”—Yogi Berra “I know what you’re thinking: ‘Did he fire six shots or only five?’ Well, to tell you the truth, in all this excitement, I’ve kinda lost track myself…you’ve got to ask yourself one question: ‘Do I feel lucky?’ Well, do you, punk?”—Dirty Harry

  • Parametric Release: What’s Involved and How Can It Be Applied to a Healthcare Setting

    At the spring 2019 IAHCSMM Annual Conference & Expo in Anaheim, CA, Beyond Clean hosted a discussion of sterilization process monitoring with chemical indicators, biological indicators, and by parametric release. The first two items are quite familiar to U.S. SPD personnel, being part of everyday life and whose use is defined in AAMI ST79:2017. On

  • Chemical Indicators: What to Use, When to Use Them, and What’s the Difference between Them All?

    Chemical sterilization indicators (CIs) are vital tools in an SPD, but since the last revision of AAMI/ANSI/ISO 11140-1, there are so many types of chemical indicators. Classes are dead. Long live the types! So what do you do with them? As always, AAMI ST79 is the definitive reference, but take it with a grain

  • Is My Water Good Enough? How Do I Know and What Do I Do If It Isn’t?

    Stains. Corrosion. Instruments worn out before their time. These are problems every sterile processing department experiences and they can be among the greatest causes of stress, be costly to fix, and drag your department into the doldrums of dissatisfaction with your surgical customers. How can you mitigate these issues? The water used in reprocessing

  • Cleaning Indicators: What, Exactly, Are They Telling Us about Washer-Disinfectors?

    Do you test your washers? AAMI ST79:2017, section 13.2, says, “Mechanical cleaning equipment should be tested upon installation, each day that it is used, and after major repairs.”[1] (I would add that full testing should be done when a new detergent is put into use. They are not all the same.) Okay, now that we’ve determined

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