Education News!

September 23, 2011

FDA Guidance on Liquid Chemical Sterilants...HERE

10th Annual - Processing and Regulatory Issues in Sterlization Program

A Continuing Education Program for Personnel Performing Decontamination, Disinfection and Sterilization

Saturday - November 5, 2011

Sponsored by Sterile Processing University and Darthmouth-Hitchcock Medical Center

Location: Dartmouth Hitchcock Medical Center - Lebanon, New Hampshire

Registration Deadline: October 28, 2011

Price: $80 per person

Faculty: Nancy Chobin, RN, CSPDM. Judy Ptak, RN, MSN. Paula Hoffman.

CEUS: 6.0 for CBSPD, IAHCSMM (pending)

Click HERE for a brochure to sign up!

AAMI has circulated a statement regarding sterilization for immediate use (formerly called flash sterilization) with the logos of the endorsing organizations.  Please see attached HERE.

AAMI asked that we disseminate this widely to your members and constituents. AAMI will include this statement with all new purchases and updates to ST79, and it is also available as a free download on their website.

FDA: Ongoing Safety Review of Arthroscopic Shavers

July 28, 2009

FDA has become aware of instances in which pieces of tissue have remained within certain arthroscopic shavers, a device used in some orthopedic surgical procedures, even after the cleaning process was believed to have been completed according to the manufacturer's instructions. Reports submitted to FDA suggested that the tissue retained was not evident to the naked eye. Multiple manufacturers of these devices recently informed their customers of this situation and reiterated the importance of proper cleaning procedures.

The FDA is concerned about this because retained tissue in these devices can compromise the entire sterilization process. They are actively working with the manufacturers of these devices to gather more data about this situation and to understand its potential public health impact. As the FDA obtains more information that better defines the situation and determines whether there are specific risks, information will be provided to facilities, healthcare providers and the public.

The FDA encourages facilities that use any of these types of devices to evaluate the adequacy of their cleaning procedures. Hospitals should consider taking the following steps to minimize any potential risk to patients:

Be sure that all personnel responsible for device cleaning and sterilization at your facility are aware of and comply with all steps in the manufacturer's instructions for thoroughly cleaning these devices prior to sterilization. Please refer to the specific instructions provided in the labeling or user manual for each brand and/or model of shaver your facility uses.

Consider inspecting the inside of the devices following cleaning to ensure that they have been cleared of any tissue or fluids. There may be multiple ways to accomplish this. As one example, the facility that brought this situation to our attention uses a 3mm video scope to inspect the channels of the shaver handpiece.

If you discover retained tissue in arthroscopic shavers at your facility after following the manufacturer- recommended cleaning procedures, you may file a voluntary report here. These voluntary reports will help gather additional information related to this problem and assess its public health impact. Visit here for more information.

Source: HPN Magazine

Joint Commission Revises Flash Sterilization Survey Standards

June 22, 2009

The Joint Commission has been in discussion with multiple professional and trade organizations in regards to the common and proper use of sterilization using steam. Recently, some decisions have been made which will have an impact on the interpretation of standards as well as the survey process.

In reviewing this method of sterilization, several issues have emerged including:

• The terminology used to describe the sterilization process. Flash sterilization is the most common term used to describe certain types of steam sterilization that do not utilize a full (also known as terminal) cycle. Originally, this term meant sterilizing unwrapped instruments using steam for 3 minutes, at 270 F. at 27 to 28 lbs of pressure. Over the last several decades, a number of improvements have been made to this process, such as longer exposure of the instruments to steam, the use of special trays and packs to hold and protect the instruments, and the routine use of biological indicators. To help sort out confusion about nomenclature, this document will only refer to steam sterilization as described above (3 minutes at 270 F at 27 to 28 lbs of pressure).
• Indication-related issues that involve the selection of the sterilization cycle or method. Previously, the selection of a sterilization cycle or method was a primary focus during a survey. Now surveyors will be looking more closely into all aspects of the sterilization method or cycle (see the next bulleted item regarding process-related issues).  Examples of findings would be a high percentage of steam sterilization using less than a full sterilization cycle, as well as exclusive use of this process for certain types of instruments.
• Process-related issues involving the way that a given sterilization method is executed.  Examples of findings would be failure to adequately clean the instruments before sterilization, lack of chemical indicators, and transporting uncovered instruments back to the operating room after they have been sterilized. 

Based on discussions with experts in the field, professional organizations, and government organizations, The Joint Commission has decided to refocus its survey efforts on all of the critical processes included in sterilization.  If a complete and effective process of sterilization is used, it will be considered an effective sterilization method.  Therefore, surveyors will review the critical steps of disinfection and sterilization to determine if the process is appropriate.

Here is a brief overview of the three critical steps of reprocessing:

1. Cleaning and decontamination.  All visible soil must be removed prior to sterilization because steam and other sterilants cannot penetrate soil, particularly organic matter.  Manufacturers’ instructions are available for all instruments; these include directions for the cleaning and decontamination process.  Some smooth metal instruments may be easily brushed clean, while complex products may require disassembly and special cleaning techniques.  Many manufacturers specify that an enzymatic soak be used as well.
2. Sterilization.  Most sterilization is accomplished via steam, but other methods are also available.  Steam sterilization of all types, including flashing, must meet parameters (time, temperature and pressure) specified by both the manufacturer of the sterilizer, the maker of any wrapping or packaging, and the manufacturer of the surgical instrument.  In addition to these instructions, parametric, chemical and biological controls must be used as designed and directed by their manufacturers.
3. Storage or return to the sterile field.  Each newly sterilized instrument must be carefully protected to ensure that it is not re-contaminated.  For full steam sterilization cycles, packs of instruments are wrapped and sealed.  Instruments subjected to steam sterilization using methods other than full cycle sterilization may be transported in “flash pans” or other devices specifically designed for the prevention of contamination during and after the steam process.

In summary, Joint Commission surveyors will focus on all of the critical steps and the integrity of the sterilization process.

Surveyors will, among other activities:

• Observe instruments from the time they leave one operating room to when they are returned to the next.
• Ask health care workers to provide the manufacturers’ instructions for instrument sterilization, and to describe and demonstrate how instruments are being cleaned and decontaminated according to those written instructions.
• Observe the cleaning of instruments.  Rinsing is rarely enough to properly remove soil from instruments; meticulous cleaning is needed.
• Verify that staff members are wearing appropriate personal protective equipment.
• Observe the sterilization process.  The surveyor will ask for the manufacturer’s instructions for the following items: the sterilizer, wrapping or packing, and the instruments.
• Review sterilization logs.  Surveyors will ask about parametric, chemical and biological indicators.
• Observe the return of instruments to the sterile field and verify that they are being protected from recontamination.

For more information, please see the CDC/HICPAC guideline at this link:
http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/Disinfection_Nov_2008.pdf

Please feel free to submit any questions at the following web address:
http://jcwebnoc.jcaho.org/SigSub/onlineform.asp

There is a new amendment from the EPA on Ethylene Oxide.

Click HERE to download it.

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