Education News!

10th Annual Processing and Regulatory Issues in Sterilization Program

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

Saturday, November 6, 2010

Co-sponsored by Sterile Processing University and Dartmouth-Hitchcock Medical Center

Location: Lebanon, New Hampshire

Registration Deadline: October 29, 2010

Fee: $80

CEUs: 6.5 for CBSPD, IAHCSMM CEUs pending approval.

Click HERE for a brochure to sign up!

Click HERE for a credit card order form!

December 8, 2009

Click HERE for an important update from the FDA on Steris System 1 Processors.

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

ALERT…….IMPORTANT INFORMATION ABOUT CHEMICAL INDICATORS

Due to the number of emails and telephone calls received from around the US about class 6 chemical indicators, a communication was made with the FDA to get clarification about these devices:

Dear Sheila

I sit on the AAMI Sterilization Committee with you and would greatly appreciate some information.  I work for the Saint  Barnabas Health Care System in NJ and some of our facilities are being asked to switch to Class VI indicators to release all loads (including implants).  As you know, AAMI has not covered these indicators.  I am of the position that since these indicators do not contain spores we should not use them for implants or for routine or qualification testing of sterilizers.

The company’s literature states they can be used for all loads and I am being told the sales rep stated that the FDA cleared their product to be used in lieu of a BI.  Any clarification would be greatly appreciated so I can prepare my rebuttal.

Thank you
Nancy Chobin, RN, CSPDM

On 4/7/09 at 9:16 AM Sheila Murphey responded:

Dear Nancy,

Thank you for your email. If the Steris sales representative stated that FDA cleared the Steris Verify SixCess Chemical Indicator to be used in place of a Biological Indicator, then he made an incorrect statement. FDA cleared this device as a "Chemical Indicator". Chemical Indicators are used in the load release decisions made for all sterilizer loads for which they are used. Chemical Indicators measure ONLY the physical parameters of the sterilization cycle. Any decision made based on the use of a Chemical Indicator to monitor a sterilization load would apply to all items in a load, since the CI does not distinguish among items in any load (neither does a Biological Indicator).

However, the JCAHO and CDC have been recommending for many years that the microbicidal performance of a sterilizer cycle used to sterilize implantable devices should be monitored by a Biological Indicator (along with a Chemical Indicator). The release decisions on such loads should be made based on the results of the cycle parameter readouts, the CI result AND the result for the Biological Indicator.

Chemical Indicators have a valid and useful role to play in the monitoring of sterilization cycles and they are often and appropriately used without a BI. However, all Chemical Indicators measure ONLY physical cycle parameters. FDA holds all Chemical Indicators to the same basic performance standards. We do not consider that  one CI is "better" than another. Indeed, we do not permit "comparative claims". Hospitals have been making load release decisions based on CIs alone for many years for certain loads but requiring the use of a BI as well as as CI for other, specified loads such as loads with implants and loads used in qualification testing.

The Steris Verify SixCess CI is a Chemical Indicator. It may be used as you would use any other Chemical Indicator. However, it is NOT a Biological Indicator and should not be used in place of a BI.

I hope that this information will be of use. Please contact me should any further questions arise.

Regards,

Sheila A. Murphey, MD
Branch Chief, Infection Control Devices Branch
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices
Office of Device Evaluation, Center for Devices and Radiologic Health
9200 Corporate Blvd Room 340H Mail Stop HFZ-480
Rockville, MD 20850
Phone 240-276-3706
Fax 240-276-3789
sheila.murphey@fda.hhs.gov

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

Click HERE to download it.

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