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Alfa Medical
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Hempstead, NY 11550
USA 1-800-801-9934
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GAC Autoclave Monitoring


 

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Global Autoclave Compliance will monitor and document autoclave sterilization effectiveness through biological spore testing. Biological spore testing is the only compliant testing method approved by the CDC, State Health Departments and Autoclave Manufacturers.

Global Autoclave Compliance guarantee's the prompt notification of results consistent with each biological indicators tested. The Global Autoclave monitoring system provides you with technologically advanced biological indicators that challenge your sterilization system. The testing supplies are delivered on a cycle consistent with your monitoring needs through a program we call "Auto-Ship Reminder". Global Autoclave Compliance provides you with comprehensive reports detailing your sterilizer results for every test incubated and monitored. If a test failure should occur, you will be notified by phone immediately in confidence, and a re-test will be issued to you.

Our monitoring system with auto-ship reminder and standard features like, no fee retrieval of records, postage paid packaging and professional customer service is unparalleled in the industry. This enables us to have the confidence that your experience with Global Autoclave Compliance will exceed your expectations. Weekly, Monthly, Bi-monthly and Quarterly contracts are available.

With regular monitoring a Global Autoclave Compliance certificate promotes additional confidence in the safety of your practice.

What you need to know about Biological Monitoring

The use of autoclave sterilization has been an indispensable method of assuring that today's equipment is sterile and safe, but what assurance do you have that your autoclave is functioning properly?

The Centers for Disease Control (CDC) vol. 42/No. RR-9 - "Proper functioning of sterilization cycles should be verified by the periodic use (at least weekly) of biological indicators (i.e. spore tests)."

For many years piercers and tattoo artists have been self regulating their industry for their own protection, i.e. single use needles, autoclave sterilization, disposable ink caps and latex gloves. These practices along with universal precautions protect the practitioners and their clients against infection and possible cross contamination.

One regulation that is being implemented into most local health code law is the requirement for third party autoclave monitoring. Spore testing and consistent up to date record keeping might seem like overkill to some but remember... an autoclave is a mechanical instrument. Small moving parts, gaskets and valves can malfunction and consequently put your business at great risk. (The CDC encourages testing regardless of whether or not it is mandatory in your state. "Sterilizer monitoring will greatly reduce your exposure to infectious diseases and other blood-borne pathogens." ) It is a proactive way to reduce legal liability while providing a safe environment for yourself, your staff and your clients.

Companies like Global Autoclave Compliance, LLC have made the process of accurate testing and log keeping simple. A spore test sample is mailed to the establishment on a recurring basis determined by the Body Mod Studio’s needs or local health department. The sterilization clinician places the sample into the autoclave for a complete sterilization cycle in the effort to kill the spores (Bacillus stearothermophilus) contained in the ampoule. The sample is then allowed to cool and return to the monitoring laboratory for incubation. After a full 48 hour incubation period the sample is examined and a pass or fail result is determined. The client is then informed of the outcome and the collected data can now be maintained for an accurate and up to date record book.

It is important to note that heat sensitive chemical indicators (e.g. those that change color after exposure to heat) alone do not ensure adequacy of a sterilization cycle. Their sole use is to identify packs that have been processed through the heating cycle. Spore Testing is the ultimate assurance that all microbial life has been destroyed.


 

National Monitoring Guidelines - Dental Practices

Centers for Disease Control and Prevention (CDC)
Guidelines for Infection Control in Dental Health-Care Settings --- 2003 MMWR December 19, 2003 / 52(RR17); 1-61.

Sterilization Monitoring

  1. Use mechanical, chemical, and biological monitors according to the manufacturer's instructions to ensure the effectiveness of the sterilization process (IB) (248,278,279).
  2. Monitor each load with mechanical (e.g., time, temperature, and pressure) and chemical indicators (II) (243,248).
  3. Place a chemical indicator on the inside of each package. If the internal indicator is not visible from the outside, also place an exterior chemical indicator on the package (II) (243,254,257).
  4. Place items/packages correctly and loosely into the sterilizer so as not to impede penetration of the sterilant (IB) (243).
  5. Do not use instrument packs if mechanical or chemical indicators indicate inadequate processing (IB) (243,247,248).
  6. Monitor sterilizers at least weekly by using a biological indicator with a matching control (i.e., biological indicator and control from same lot number) (IB) (2,9,243,247,278,279).
  7. Use a biological indicator for every sterilizer load that contains an implantable device. Verify results before using the implantable device, whenever possible (IB) (243,248).

American Dental Association (ADA) Monitoring Sterilizers - Biological Indicators

Monitor sterilizers at least weekly with biological (spore) indicators.1 Check whether your state dental board has different requirements.

Consider using biological (spore) indicators daily if the sterilizer is used frequently (e.g., several loads per day). Daily monitoring allows for earlier discovery of equipment malfunctions or procedural errors.

A positive spore test result indicates that sterilization was incomplete. Maintain a log of spore test results. Check your state regulations to determine how long you need to keep spore testing records.

Organization for Safety and Asepsis Procedures (OSAP)

Infection Control Guidelines: September, 1997
Sterilization Monitoring: The use and functioning of heat sterilizers should be biologically monitored at least weekly, or more often if the practice demands it, with appropriate spore tests. Place the spore strips or vials inside a pouch, bag, pack or cassette, and include this package as part of the normal load through a normal sterilizer cycle. Always use a control spore strip or vial (not heat processed but otherwise treated identically to the test strips or vials) with each spore test performed. Additionally, chemical indicators should be used on the inside of each package during every sterilizer load. Accurate records of sterilization monitoring must be maintained. A chemical indicator from inside each pack may be initialed and dated for each day of patient care and kept in a file. The weekly spore test for each heat sterilization unit may be kept in the same file. Biologically monitor whenever there is a change in packaging, following equipment repair; retest after failure and when training new employees.

Association for the Advancement of Medical Instrumentation (AAMI)

AAMI: Steam Sterilization and Sterility Assurance, 7.5.4 Test Frequency.

"Biological indicators must be used no less than weekly for each sterilizer and, preferably, should be used for each load. More frequent testing should be carried out on an as needed basis (I.E., after major sterilizer repairs, when evaluating sterilization of new products, when implantable or intravascular materials are sterilized, etc.)".

Association of Perioperative Registered Nurses (AORN)

Recommended Practices, Sterilization & Disinfection, 1987.

"For routine monitoring should be used weekly, and as needed; each load of implantables."

Veteran's Administration (VA)

VA Manual G1, MP-2, 1985 and MP-2, Sub-chapter E, Change 159, June 22, 1983.

"Must be monitored no less than weekly, each load of implantables or intravascular materials, following major sterilizer repairs, new products or packaging material."

Dental Practice Spore Testing Requirements:

This chart indicates individual state law for mandating spore testing responsibility.

Other states may have county by county regulations. The national monitoring guidelines should supersede the legal requirements for states not mandated by local government.

Tattoo and Body Arts Studio’s Spore Testing Requirements:

This chart indicates individual state law for mandating spore testing responsibility.

Other states may have county by county regulations. The national monitoring guidelines should supersede the legal requirements for states not mandated by local government.






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