Medical Device Regulation: US or EU

Food, Drug and Cosmetic Act In the States, medical devices are regulated by the Food, Drug and Cosmetic Act. Then called the Food and Drug Act, it was the first piece of legislation to result from investigative journalism, namely a novel titled “The Jungle” by Upton Sinclair. Sinclair described the filthy conditions of pre-WWI Chicago stockyards … Read more

Association of Professional Piercers 15th Annual Conference and Exposition

Online Registration by Cvent | Summary – Association of Professional Piercers 15th Annual Conference and Exposition. We are now open for both Full Conference Pass registrations and Individual Class registrations! NEW! Hands-on workshops Attendees must sign up for a single workshop session in order to attend. This includes all Full Conference Pass attendees. This new approach … Read more

Mosaic Law Related to Purification

BOOK OF LEVITICUS Chapter 13 The complete chapter relates to purification laws. Chapter 14 The complete chapter relates to purification laws. Chapter 15 The complete chapter relates to purification laws. BOOK OF NUMBERS Chapter 5 1 The LORD said to Moses, 2 “Command the people of Israel that they put out of the camp every … Read more

A brief history of sterilization

A Brief History of Sterilization : An educational overview of some of the important historical steps forward in infection control and sterilization

An educational overview of some of the important historical steps forward in infection control and sterilization

CBSPD

Interesting lead: The Certification Board for Sterile Processing and Distribution, Inc. (CBSPD), formerly the NICHSPDP, is a non-profit Certification Board which plans, develops and administers competency-based “International” certification examinations for personnel performing cleaning, disinfection, sterilization and inventory management activities, regardless of the setting. via About the CBSPD, Inc..

Educational materials for Decontamination, Packaging and Sterilization – Case Medical Inc

via Case Medical Inc. CASE ACADEMY ONLINE DESCRIPTION DOWNLOAD BASICS OF DECONTAMINATION – TUTORIAL CASDF001 BASICS OF DECONTAMINATION GLOSSARY CASDF001g BASICS OF DECONTAMINATION POST-TEST ANSWER KEY CASDF001a BASICS OF PACKAGING – TUTORIAL CASDF002 BASICS OF PACKAGING GLOSSARY CASDF002g BASICS OF PACKAGING POST-TEST ANSWER KEY CASDF002a BASICS OF STERILIZATION – TUTORIAL CASDF003 BASICS OF STERILIZATION – GLOSSARY … Read more

Questions and Answers about Flash Sterilization

Statim autoclaves are not “flash” sterilizers.

SciCan’s STATIM cassette sterilizers have a biological effectiveness that has been proven in tests for hollow and solid instruments at many internationally recognized institutes in Canada, the United States, and Europe.

See this statement for more information:

AAMI, AORN, APIC Issue Immediate Use Sterilization Statement

…“flash sterilization” is an antiquated term that does not fully describe the various steam sterilization cycles now used to process items not intended to be stored for later use. Read the full ST79 Statement for details here and AAMI Article here

Question: What is flash sterilization?

Flash Sterilization usually means steam sterilization of an unwrapped instrument or device for 3 to 10 minutes in 270° F saturated steam. Flash sterilization is usually accomplished with a gravity displacement cycle, although certain newer sterilizers may employ a vacuum at the beginning or end of the cycle to remove air, steam, or aid in drying.

Question: Why use flash sterilization?

Flash sterilization is used when rapid sterilization of instrument or devices is required. This need may be the result of a limited number of instrument sets, a need for unanticipated instruments, or a contaminated instrument.

Question: What is the main problem with flash sterilization?

The problem is not with the sterilization process, but with the difficulty in maintaining sterility at the end of sterilization. It has been common practice to sterilize items in an open mesh basket. Upon removal from the sterilizer, the basket containing the items is covered or wrapped. The basket is then transported through non sterile areas to the operating site.

Once the sterilizer is opened at the end, of the cycle, the basket and its contents may be exposed to recontamination. Even with subsequent wrapping or covering, it is difficult to ensure the items have remained sterile.

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Event Related Sterility – Sterile & Materials Processing Department – University of Rochester Medical Center

  Event Related Sterility I-Introduction Event-Related Sterility Maintenance Policy defines procedures intended to maintain the sterility of packages until they are used. This document focuses on event-related sterility maintenance of hospital-prepared packages containing sterile supplies wrapped in single-use or reusable materials. Since some supplies have expiration dates and degrade over time, this document covers only … Read more

Basics on Processing & Sterilization – Sterile & Materials Processing Department – University of Rochester Medical Center

Hydrim instrument washer

via Basics on Processing & Sterilization – Sterile & Materials Processing Department – University of Rochester Medical Center. URMC / Sterile & Materials Processing Department / Basics on Processing & Sterilization Basics on Processing & Sterilization Table of Contents Introduction Functions The Decontamination Process The Assembly & Packaging Process The Sterilization Process Quality Assurance Introduction The Sterile Processing Department (Central … Read more

Infection Control Today – 09/2003: Surgical Prep: The Right Product for the Right Function

Another article on choosing the right surgical prep solution Until Technicare returns… Infection Control Today – 09/2003: Surgical Prep : Surgical Prep: The Right Product for the Right Function. https://www.medcompare.com/matrix/2691/Antiseptic-Skin-Preparation-Solution-and-Gels.html https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2526523/ CHG risks Technicare substitutes