January 2013

Dear Certified Sterile Processing Supervisor or Manager:

In November, 2012, the CBSPD merged the Certified Sterile Processing Supervisor and Certified Sterile Processing Manager examinations into one credential called “Certified in Sterile Processing Management”. This decision was based upon data collected that revealed minor differences in the responsibilities for these positions. This exam is for supervisors and managers as well. Job Analyses performed by the CBSPD in 2012 revealed a consensus from the survey participants that the exams should be merged as well as the new exam content.

This letter is to advise you that your current certification as a CSPDS or CSPDM is NOT affected by this new credential. As long as you continue to meet the re-certification criteria, you can keep your original credential and do not have to re-take an exam.

If you have any questions, please contact us at: mailbox@sterileprocessing.org or 908.236.0530.

Thank you for your support of the Certification Board for Sterile Processing & Distribution, Inc.

Continued success in tour sterile processing profession.

Sincerely,

CBSPD, Inc. Board of Directors

-- New CBSPD Office Address!

March 7, 2012 - 2 am Eastern

As of today, we are moving to a bigger office in the same complex we were at before. We are in suite C-1 now. Our new address is below.

CBSPD
148 Main Street
Suite C-1
Lebanon, NJ 08833

We will be updating all of our order forms online to reflect this change. The new applications for the cert exams which will be ready by the end of this month will have this new address change. Please be sure to send in your exam applications starting in May 2012 to our new address.

Our phone numbers and email will remain the same.

Our office will be closed today and possibly on Thursday as we complete the move. You can call us and leave a message and as soon as we are settled in, we will return your call. You can also email us.

Thank you for being patient during this time that we move.

CBSPD Board of Directors

-- Many Updates

February 27, 2012 - 515 am Eastern

The November 2011 exam passers have been posted HERE.

The February 2012 exam passers should be posted in a couple of weeks or sooner.

The February 2012 exam results for the USA were mailed out on 2/23/12. Please allow 5-7 business days for the mail to reach you.

August 2012 re-certification packets were mailed out last week. They are also posted on-line on our downloads page.

A recent video update worth looking at...Why Education/Certification Matters! See links below!

Link 1 and Link 2.

-- New Surgical Instrument Specialist Exam in August / New Books Soon
-- 2011 Multisociety Guideline on Reprocessing Flexible GI Scopes

June 18, 2011 - 1230 am Eastern

We are on schedule to introduce our new exam in August for the Surgical Instrument Specialist Certification. We are working on getting a new study guide printed for this exam, and we will also be selling an additional instrument book to go along with it. The one main thing to note with this new exam is that you MUST be already certified as a CBSPD SPD Technician first before you can sit for this new instrument exam. Those that were previously certified as a surgical instrument tech and processor will still have a valid certification with us under those names, however, those certifications will NOT be carried over to this new credential. If any of those certificants who hold the surgical instrument tech/processor credential, will have to pass the new surgical instrument specialist exam to obtain the new credential. We will be updating the new candidate bulletin and surgical instrument web page online within the next week or so. Stay tuned for more information.

There are new guidelines for reprocessing flexible gi scopes posted here to download.

-- Steris System 1/Feb 2011 Passers/Oct 2011 Re-cert Packets --

May 5, 2011 - 415 am Eastern

There has been an update from the FDA on the Steris System 1. Check out this link HERE for details on this important announcement.

All of the people that passed our Feb 2011 certification exams are now posted on our website HERE.

For those that are due to re-certify in October 2011, you can download a copy of the re-cert packet from our downloads page HERE. We will be mailing out the hard copies within the next 2 weeks. If you have changed your address within the last 5 years, please contact our office to be sure you receive your packet in the mail.

-- Many Announcements --

March 15, 2011 - 220 am Eastern

The Candidate bulletins with exam applications for the May 2011 exams are now online. Please see our exam page links at the top of the page in yellow or the downloads page to download a copy.

We are in the process of grading the international results from the February admin. We should have them mailed out within a week.

The winter newsletter is now online HERE. We will be sending the newsletter to our printer this week. It will be mailed out to all of our certified members as soon as the print job is done.

The new list of re-certified members from April 2010 is online HERE. The October 2010 list is delayed at this time because there are still some members that have extensions that were granted. We hope to have the October list posted soon.

The Ambulatory Surgery Tech job analysis survey has ended and we are processing the results now. This data will assist in updating that exam which we will start to work on as soon as the survey results are processed. For those that signed up for the free gift, we will be mailing them out soon. Thanks to all that participated. We will be posting the next survey for the GI Scope exam. Stay tuned for that very soon.

We now have a vacancy on our board of directors for the spd technician position. We will be holding an election this summer, but before then, we will be accepting nominations. We will have info on this soon as well.

Stay tuned for updates.

-- New from AAMI: Immediate Use Statement --

February 22, 2011 - 615 pm Eastern

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.

January 3, 2011 - 3AM Eastern

The complete list of all the new members who passed the November 2010 certification exams is posted HERE.

Anyone that took the exams outside of the USA, please note, we just sent out your final exam results recently and you should have them soon.

-- The Costs of Surgical Instrument Training --

August 16, 2010 - 1150 pm Eastern

A new paper written by the CBSPD Executive Director, Nancy Chobin is now available to download by clicking HERE.

-- CDC Hand Hygiene In Healthcare Settings Website --

June 4, 2010 - 130 am Eastern

CDC Launches New Hand Hygiene in Healthcare Settings Website

In association with the World Health Organization’s "Save Lives: Clean Your Hands" annual initiative, CDC has launched a new “Hand Hygiene in Healthcare Settings” website.  This site provides healthcare workers and patients with a variety of resources including guidelines for providers, patient empowerment materials, the latest technological advances in hand hygiene adherence measurement, frequently asked questions, and links to promotional and educational tools published by the WHO, universities, and health departments.

Learn more at http://www.cdc.gov/handhygiene/index.html

-- Update On Steris System 1 and Criterion Newsletter --

February 2, 2010 - 1159 pm Eastern

Please check out our web page HERE for the latest announcement.

Our winter edition of the Criterion newsletter is now available online HERE. We will be mailing them out to all certified members over the next couple of weeks.

-- Important Info from FDA on Steris System 1 Processor --

December 8, 2009 - 440 pm Eastern

Check out this link HERE for details on this important announcement.

-- New Vendor Certification Page --

October 5, 2009 - 615 pm Eastern

If you are a vendor, we have a new web page for you to visit if you are looking to get certified with us. Please click HERE!

-- FDA: Ongoing Safety Review of Arthroscopic Shavers --

July 28, 2009 - 1130 pm Eastern

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 - 1130 pm Eastern

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

-- Important News on Chemical Indicators --

April 11, 2009 - 6 pm Eastern

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 4/10/09 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

-- New Link from CDC --

November 21, 2008 - 315 pm Eastern

There is a new document out from the CDC. Its for Guidelines for Disinfection and Sterilization in Healthcare Facilities. There is a link to download the pdf file as well as other downloads from the CDC located HERE.

-- CBSPD Receives New NCCA Accreditation! --

June 23, 2008 - 930pm Eastern

The CBSPD is proud to announce that it has once again received accreditation for its Technician, Supervisor, and Manager certifications from the NCCA (National Commission for Certifying Agencies).
See our official press release.

Please note, our surgical processor and ambulatory surgery certifications are pending approval at this time. We fully expect those certifications to be accredited as well.

-- New Office Policy --

April 25, 2008 - 1145 pm Eastern

Please note, the CBSPD, Inc. NO LONGER will accept purchase orders of any kind. All payments for orders must be made in advance with a credit card, bank or facility check.

-- News on Ethylene Oxide from the EPA --

January 16, 2008 - 230 pm Eastern

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

Click HERE to download it.