Important CBSPD Announcements
-- Connecticut passes CS/SPD Certification Bill & AAMI Standard ST-91 Published --
June 7, 2015 - 500 am Eastern
On Thursday, May 28, 2015, Connecticut Gov. Dannel P. Malloy signed the
long-anticipated legislation (Public Act No. 15-11) into law, which
will require all CS/SPD staff to have certification credentials from an
accredited organization. For anyone seeking a job in Connecticut as a
Central Service/Sterile Processing and Distribution department (CS/SPD)
technician, starting next year, they will need to get registered and
certified according to new legislation slated to take effect in January
Key language in the bill, effective January 1, 20016, states that no
person shall practice as a central service technician unless he or she
makes Connecticut the third state, behind New York and New Jersey, to
mandate certification for healthcare employees who decontaminate and
sterilize reusable medical instruments and devices. IAHCSMM
representatives spent the last three years lobbying for the law's
adoption and educating state legislators about what CS/SPD technicians
do and why having certification is critical to patient safety. More
states are expected to pass similar laws, particularly with today's
newer instruments becoming more complex and harder to clean. However,
some healthcare facilities have refused to wait, with a growing number
now implementing policies of their own that require CS certification
for new and existing CS/SPD staff.
passed a nationally-accredited central service exam for CS technicians
and holds and maintains credentials as a certified registered central
service technician credential administered by the International
Association of Healthcare Central Service Materiel Management (IAHCSMM)
or a certified sterile processing and distribution technician
credential administered by the Certification Board for Sterile
Processing and Distribution Inc. (CBSPD); or
employed or otherwise contracted for services as a CS technician in a
healthcare facility before January 1, 2016 or obtains within two years
of hire or contract with a healthcare facility, a certified registered
CS technician credential administered by IAHCSMM or a certified sterile
processing and distribution technician credential administered by
- Must complete a minimum of 10 hours of continuing education annually related to the functions of a CS technician.
AAMI publishes national standard for flexible and semi-rigid
endoscopes. ST-91 is designed to prove end users with
evidence-based recommendations for safe processing of semi-rigid and
flexible endoscopes. Contact AAMI at www.aami.org to order a copy.
-- Recommendations for processing duodenoscopes used for ERCP procedures and more --
March 23, 2015 - 525 AM EDT
Newest updates from the FDA/CDC. Click HERE!
-- EBOLA UPDATE --
November 5, 2014 - 1 AM EST
MULTISOCIETY STATEMENT ON PROCESSING BIOHAZARDOUS MEDICAL WASTE
The recent outbreak of Ebola virus disease has raised questions about
the correct handling of Ebola contaminated biohazardous medical waste.
This joint advisory statement is intended to provide guidance to
personnel and health care organizations for handling biohazardous
medical waste, including waste contaminated with the Ebola virus.
This statement addresses the use of sterilizers for processing
biohazardous waste in the health care facility. This document does not
address transportation of biohazardous waste, or processing of
contaminated reusable medical devices and textiles.
Recognizing that sterilization modalities other than moist heat may be
used for processing biohazardous waste, the term
“sterilizer” is used rather than
“autoclave” as used in other guidelines.
This is an evolving issue and healthcare professionals should review
current research and incorporate new evidence into practice to mitigate
occupational and patient risk associated with handling biohazardous
AAMI, AORN, APIC, AST and IAHCSMM recommend that:
1. Health care organizations should not circumvent established protocols for handling biohazardous medical waste.
2. Biohazardous medical waste should not be brought into clean areas where processing reusable medical devices is performed.
3. Biohazardous medical waste should not be inactivated in a sterilizer that is used for processing reusable medical devices.
4. Sterilizers used to inactivate biohazardous medical waste should be designed and validated for that particular purpose.
5. Organizations should work with infection preventionists and keep
abreast of evolving professional and regulatory guidelines for handling
biohazardous medical waste.
-- EBOLA AND STERILE PROCESSING PERSONNEL – FACT LIST --
October 16, 2014 - 300 PM EDT
As you are aware, there is much concern about the Ebola virus in the
United States. To protect healthcare workers, the Centers for
Disease Control have published extensive guidelines for personnel to
protect themselves. Visit http://www.cdc.gov.
The virus is spread through direct contact (through broken skin or
mucous membranes) with the body fluids (blood, urine, feces, saliva,
and other secretions) of a person who is sick with Ebola, or with
objects like needles or instruments that have been contaminated with
the virus, or infected animals. At this time, ebola is not
spread through the air or by food or water.
According to the CDC, When treating patients, healthcare workers MUST
wear: gloves, gown (fluid resistant or impermeable), shoe covers, eye
protection (goggles or face shield), and a fluid resistant facemask.
Additional PPE may be required in certain situations (e.g., copious
amounts of blood, other body fluids, vomit, or feces present in the
environment), including but not limited to double gloving, disposable
shoe covers, leg and head coverings.
Personnel performing cleaning and disinfection MUST wear recommended
PPE and consider use of additional barriers (e.g. fluid resistant head
and leg coverings) if needed.
Face protection (face shield or facemask with goggles) MUST be worn
when performing tasks such as liquid waste disposal that can generate
All non-dedicated, non-disposable medical equipment used for patient
care should be cleaned and disinfected according to manufacturer's
instructions and hospital policies.
Apply PPE correctly; make sure it fits and covers all skin and mucous
membranes (e.g. mouth, eyes, nose). Take care when handling
Remove PPE correctly. The CDC has published posters to serve
as a reminder how to safely remove PPE. If you are not sure
of the correct procedure, check with your department manager or
infection control preventionist.
-- Newly Elected Surgical Instrument Specialist Board Member --
July 10, 2014 - 408 PM EDT
The CBSPD is pleased to announce and welcome our newly elected
Board member for the Surgical Instrument Specialist position, Rebecca
CONGRATULATIONS REBECCA AND WELCOME TO THE CBSPD BOARD OF DIRECTORS!
We are thrilled to have you to be part of our organization!
-- ATTENTION CERTIFIED STERILE PROCESSING AMBULATORY SURGERY TECHS AND CERTIFIED GI SCOPE MEMBERS --
November 24, 2013 - 139 AM EST
The CBSPD is soliciting for NEW Item Writers/Reviewers
for these two CBSPD exams. We will train
you in how to write a question. You will
receive CEUS for your participation. Be
part of this prestigious Committee.
Representation is needed from all areas of the US including northeast,
southeast, central, midwest, northwest and southwest.
1. Minimum of 2 years’ experience in your profession.
2. You must be CBSPD certified as an
Ambulatory Surgery SPD Technician or Certified Flexible Endoscope reprocessor .
3. You must be available for regular
training/review meetings which are usually scheduled for Saturday mornings.
4. Must sign a letter of confidentiality.
If interested, please contact the CBSPD office at
:firstname.lastname@example.org. We will
send a form to you for completion.
Be an important part of your profession and earn CEUS
-- IMPORTANT CBSPD PRESS RELEASE --
November 12, 2013 - 945 PM EST
RELEASE – CBSPD REORGANIZES FOR THE FUTURE – Technician Exam Received
Re-Accreditation until 2018.
At the annual meeting of
the Board of Directors of the Certification Board for Sterile Processing &
Distribution, Inc. changes in the administration of the organization were
unanimously approved by the Board. Nancy
Chobin, RN, CSPM, founder, has retired from the position as Executive Director
of the CBSPD. According to Nancy, “the
past 25 years have been the most rewarding experience of my professional
career. I feel so privileged to have
had the opportunity of starting a program that has grown to be world recognized
as the leader in competency-based certification programs for personnel providing
reprocessing services.” One of the most fulfilling accomplishments was
achieving accreditation for our technician, supervisor and manager exams
through the National Commission for Certifying Agencies (NCCA). Our technician examination has been accredited
since 1993. We are proud to announce the
technician exam has been awarded re-accreditation through 2018. The Manager and Supervisor certification
examinations were merged last fall. The
CBSPD will be completing an application for accreditation of the new Management
credential in 2014.
Over the past four years, Karen Swanson, LPN, CSPM,
Sterile Processing Team Leader at Connecticut Children’s Medical Center,
Hartford, CT has been training to assume leadership of the CBSPD. The change became effective November 1,
2013. Karen has been a long time CBSPD
supporter and for the past five years has chaired the CBSPD Item Review
Committee. Chobin states “I know the
CBSPD will continue to be an influential organization in healthcare. Karen is prepared to meet whatever challenges
lie ahead for the CBSPD and healthcare in general”. Nancy Chobin will be an advisor to the board
and assist with Item Writing and Item Review.
According to Karen Swanson, “It has been a privilege to
work closely with Nancy since 2000 when I first became an item writer and board
member. Nancy has devoted her life to
this organization and I am honored to have been chosen to follow in her
footsteps. Going forward we all will face many challenges in healthcare. The
CBSPD will continue to be in the forefront providing competency -based
certification to those who are responsible for the safety of the patients we
Board of Directors, CBSPD
-- NY State Passes Mandatory Certification --
September 11, 2013
The CBSPD is proud to have been part of this effort and will
continue to support required certificaiton in the US and
Go to the link below and scroll down to the video and click on it.
August 1, 2013
The Board of Directors of the CERTIFICATION BOARD FOR STERILE PROCESSING &
DISTRIBUTION , INC. congratulates New
York State in becoming the second state (next to New Jersey ) to pass
legislation requiring certification for sterile processing technicians. The CBSPD supported this legislation and is
excited that it has passed.
This is a great day for sterile processing and a big
step forward in patient safety initiatives.
The CBSPD will continue to support all efforts to achieve certification
in all remaining states.
The CBSPD is a free-standing, independent certification
board whose certification programs are accredited by the National Commission
for Certifying Agencies. The CBSPD is
ready to assist sterile processing personnel to succeed in this endeavor.
Board of Directors, CBSPD
-- Announcement of New Exam Payment Rules --
all exams going forward. If the applicant sends in to the
CBSPD office their completed application and payment up to 2 weeks before the current application deadline,
the standard exam fee will apply ($125 for all exams except the
Mangement). If the completed application and payment is received
after that time, there will be a $10 increase in pay. So the cost
will be $135 for all but the managment exam (that exam will be $160).
For credit card payments, there will be the standard $3 charge on top of the normal payment (late or early).
If the candidate registers late, and have a company check already made
out for the $125 (or $150 for the management), ea., then the CBSPD will register the
candidate(s) and allow them to test. However, the CBSPD won't release
the candidate(s) grades until the additional money is paid.
-- Announcement of New Management Exam --
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
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: email@example.com
Thank you for your support of the Certification Board for
Sterile Processing & Distribution, Inc.
Continued success in tour sterile processing profession.
CBSPD, Inc. Board of Directors
Dear Certified Sterile Processing Supervisor or Manager:
-- All August Exam Passers Posted --
The list of all the Aug 2012 exam passers has been posted HERE.
-- Updates --
note: The existing supervisor and manager exams will be combined into a
new management exam starting in Nov 2012. The supervisor and manager
certifications will still be valid until you fail to re-certify. There
will also be a new technician exam given in Nov 2012. These 2 new exams
will not have a preliminary result given for the Nov administration. We
will return to giving prelim results on exam day in Feb 2013.
We will be updating the new exam pages this month so stay tuned for
more details on the new exams. Both exams will now only be 100
questions and the time to complete the exams will be 2 hours. The tech
exam will remain at $125 and the new management exam will remain at
In other news....
Frequently Asked Questions: ASP STERRAD® CYCLESURE® 24
Biological Indicator (BI) (P/N 14324) Recall can be found HERE with this file to download.
-- 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.
148 Main Street
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.
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
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
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
Stay tuned for updates.
January 3, 2011 - 3AM Eastern
The complete list of all the new members who passed the November 2010 certification exams is posted HERE.
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
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.
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
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
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:
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
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.
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.
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
Here is a brief overview of the three critical steps of reprocessing:
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.
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.
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.
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
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.
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:
Please feel free to submit any questions at the following web address:
-- Important News on Chemical Indicators --
April 11, 2009 - 6 pm Eastern
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:
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.
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.
Nancy Chobin, RN, CSPDM
On 4/10/09 at 9:16 AM Sheila Murphey responded:
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).
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.
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.
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.
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
-- 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
-- New Instructional CD for Best Selling Textbook --
November 5, 2008 - 5 pm Eastern
EDUCATORS AND INSTRUCTORS....Sterile Processing University is now
offering a CD with power point presentations of all 10 chapters of the
Basics of Sterile Processing textbook (the textbook recommended for our CBSPD exams).
Each chapter is outlined to facilitate teaching lessons. The CD cost is
$150 each. Those that purchase the CD at the full price will be
eligible to receive the updates to the lessons (as the textbook is
updated) at a reduced cost of only $25 for all the updates. Educators
and Instructors ORDER NOW 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.
-- Press Release / Final Exam Passers to be posted --
September 19, 2007 - 4 pm Eastern
Please see our latest press release on the IAHCSMM/ASHCSP merger here.
We will be posting the final list with stats for the August
certification exams on the downloads page. Expect the final list (that
now includes our international passers) to be posted by later tonight.