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 moreMedical Device Regulation: US or EU

Japanese Scientists Create Elastic Water

1:30 PM – January 25, 2010 – By Kevin Parrish – Source : Tom’s Guide US Elastic Water could eventually replace plastic, or be used in an environmentally-safe plastic. Bernama, a part of the Malaysian National News Agency, reports that Japanese scientists have created “elastic water.” Developed at the Tokyo University, the new material consists … Read moreJapanese Scientists Create Elastic Water

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 moreAssociation of Professional Piercers 15th Annual Conference and Exposition

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

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.

Read moreQuestions and Answers about Flash Sterilization

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

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

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. http://www.medcompare.com/matrix/2691/Antiseptic-Skin-Preparation-Solution-and-Gels.html http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2526523/ CHG risks Technicare substitutes

Grand Challenges – Engineering Challenges

Grand Challenges – Engineering Challenges. The century ahead poses challenges as formidable as any from millennia past. NAE Recognizes 2013 Grand Challenges Scholars Watch Recorded Video of the Summit US Global Grand Challenges Summit Video Contest Winners Announced Here are the Grand Challenges for engineering as determined by a committee of the National Academy of … Read moreGrand Challenges – Engineering Challenges