The U.S. Food and Drug Administration cleared the first duodenoscope with a disposable distal cap, a new feature that will improve access for cleaning and reprocessing The Pentax ED34-i10T model duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems.
"We believe the new disposable distal cap represents a major step towards lowering the risk of future infections associated with these devices," said William Maisel, MD., M.P.H., acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health. "Improving the safety of duodenoscopes is a top priority for the FDA, and we encourage companies to continue to pursue innovations that will help reduce the risk to patients."
It is critical that hospitals and healthcare facilities meticulously follow manufacturer's reprocessing instructions for cleaning and disinfecting duodenoscopes. This lowers the risk of spreading infections between patients. While the risk of infection transmission cannot be completely eliminated, the benefits of these devices continue to outweigh the risks in appropriately selected patients.
In January 2017, the FDA issued a Safety Communication alerting healthcare providers about a design issue with an earlier version of the Pentax duodenoscope, the ED-3490TK. The communication identified the potential for cracks and gaps to develop in the adhesive that seals the duodenoscope's distal cap onto the scope.
These cracks and gaps could allow fluids and tissue to leak into the duodenoscope.
The new features of the Pentax ED34-i10T include a single use detachable and disposable distal cap, simpler user interface, improved ergonomics, improved image quality, and a reduced length. The FDA granted clearance of the ED34-i10T to Pentax of America.
FDA has the release.
New Board Members Elected
Technician Representative: Deborah Hager, CSPDT from New York
GI Scope Representative: Christopher Franklin, CFER, CSIS, CSPDT from Indiana
Surgical Instrument Specialist Representative: Natoria Pettyjohn, CSIS, CSPDT from Delaware
Congratulations to our new Board members!
Superbug' fungus spreading through NJ hospitals
By Dino Flammia, NJ101.5 News - May 2, 2017 7:41 PM
Described by the Centers for Disease Control and Prevention as a serious global health threat, a drug-resistant fungus is sickening hospitalized patients in a handful of states, and New Jersey is one of them.
New Jersey has had 17 confirmed clinical cases of the potentially-fatal infection known as Candida auris, first identified in Japan in 2009.
"We are doing ongoing investigations at impacted health care facilities and we have done several site visits with impacted facilities," a spokesperson for the state Department of Health told New Jersey 101.5.
Risk factors of C. auris, the department said, include recent surgery, diabetes, previous antibiotic and antifungal use, and central venous catheter use.
It's caused infections of the bloodstream, wounds and ears, the CDC reports. Sixty percent of people with C. auris have died, according to the CDC. However, many of the victims also suffered from other serious illnesses.
According to the CDC, the harmful form of yeast has been difficult to identify without specialized laboratory methods. Conventional lab work could lead to misidentification and inappropriate treatment, making it difficult to control the spread of the fungus.
C. auris often does not respond to commonly-used antifungal drugs, but a certain class of drugs known as echinocandins has been known to treat the infections.
Shannon Davila, director of the Institute for Quality and Patient Safety with the New Jersey Hospital Association, said professionals in the healthcare community may refer to this fungus as a "superbug" because of its resistance to common treatment - similar to other organisms such as MRSA.
According to Davila, New Jersey hospitals are challenged with keeping up with drug-resistant infections, and many hospitals are looking to improve "antibiotic stewardship."
"Really looking at how we are identifying infections," Davila explained. "Are we prescribing antibiotics appropriately? Because one of the main reasons why we see antibiotic-resistant infections is overuse of antibiotics."
A map from the CDC, last updated in April, shows the fungus has hit six states. Nearly 40 cases were reported in New York.
A topic page on the 2011 NIOSH Health and Safety Practices Survey of Healthcare Workers was recently posted on the NIOSH website (https://www.cdc.gov/niosh/topics/healthcareHSPS/). This page represents a one-stop resource for information on survey objectives, methods, and findings related to selected chemical hazards commonly found in healthcare settings. Links are provided to published articles and literature resources. The survey instrument is also available upon request.
-- Certification Board for Sterile Processing and Distribution announces accreditation of Flexible Endoscope Reprocessor and Certified in Sterile Processing Management certifications. --
October 12, 2015 - 400 am Eastern
It is with great pride the CBSPD Board of Directors announces the CBSPD Flexible Endoscope Reprocessor (CFER) and Certified in Sterile Processing Management (CSPM) certifications have each received a 5 year accreditation from the National Commission for Certifying Agencies (NCCA).
NCCA accredited standards help to ensure the health, welfare and safety of the public. Accreditation provides third party validation that the CBSPD certification programs have met recognized national and international credentialing industry standards for development, implementation and maintenance of our certifications that assess professional competency.
The Certified Flexible Endoscope Reprocessor is the only accredited certification program of this type.
-- Federal Agency Alerts: Addressing Device Reprocessing Challenges --
September 19, 2015 - 200 am Eastern
This week, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) issued two separate communications addressing instrument reprocessing concerns. The first, a September 11, 2015, joint alert by the CDC and FDA, identifies an immediate need to review procedures for cleaning, disinfecting and sterilizing reusable devices. Another communication was released by the FDA on September 17, 2015, to address flexible bronchoscope reprocessing concerns.
What follows is a summary of the two alerts, along with links to the full communications.
CDC and FDA: Immediate Need to Review Procedures for Cleaning, Disinfecting and Sterilizing Reusable Devices
The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are alerting healthcare providers and facilities about the public health need to properly maintain, clean and disinfect or sterilize reusable medical devices. Recent infection control lapses due to non-compliance with recommended reprocessing procedures highlight a critical gap in patient safety.
Healthcare facilities that utilize reusable medical devices are urged to immediately review current reprocessing practices at their facility to ensure they are complying with all steps as directed by the device manufacturers, and have in place appropriate policies and procedures that are consistent with current standards and guidelines. The full alert, which outlines specific steps that can be taken to minimize risks associated with reprocessing reusable medical devices, can be accessed here.
FDA Communication Addresses Flexible Bronchoscope Reprocessing Concerns
On September 17, 2015, the U.S. Food and Drug Administration (FDA) shared preliminary information regarding infections associated with the use of reprocessed flexible bronchoscopes. Although this information is limited, healthcare providers may benefit from awareness of the issues FDA is seeing and of steps they can take to mitigate possible risks to patients. The FDA has undertaken an ongoing comprehensive investigation into infections associated with reprocessed reusable medical devices, working with federal partners, manufacturers, and other stakeholders to better understand the critical factors contributing to device-associated patient infection and how to best mitigate them.
For recommendations for healthcare facilities and staff that reprocess flexible bronchoscopes and details on the FDA's activities, please refer to this FDA Safety Communication and MedWatch Safety Alert.
-- New Board Members Elected --
September 7, 2015 - 300 am Eastern
Last week, we closed the voting for the two vacant positions we had on our Board of Directors. We tallied all the votes, and we are pleased to announce our new representatives:
Technician: Michelle Milner from Abita Springs, LA. Worked at UNC Hospital.
Management: Steven "Travis" Paluck from St. Louis, MO. Travis is the manager for the Central Sterilization Department as well as the OR Supplies Management department at St. Anthony’s Medical Center.
Congratulations Michelle and Travis! We welcome you to the CBSPD Board!
-- 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 2016.
Key language in the bill, effective January 1, 20016, states that no person shall practice as a central service technician unless he or she has:
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 medical waste.
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 splashes.
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 sharps.
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 Langston.
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 :email@example.com. We will send a form to you for completion.
Be an important part of your profession and earn CEUS as well!
-- IMPORTANT CBSPD PRESS RELEASE --
November 12, 2013 - 945 PM EST
PRESS RELEASE – CBSPD REORGANIZES FOR THE FUTURE – Technician Exam Received Re-Accreditation until 2018.
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 serve.”
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 internationally.
Go to the link below and scroll down to the video and click on it.
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 --
For 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 --
January 2013 Dear Certified Sterile Processing Supervisor or Manager:
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: firstname.lastname@example.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.
CBSPD, Inc. Board of Directors
-- All August Exam Passers Posted --
The list of all the Aug 2012 exam passers has been posted HERE.
-- Updates --
Please 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 $150.
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!
-- Many Updates
-- Steris System 1/Feb 2011 Passers/Oct 2011 Re-cert Packets --
-- Many Announcements --
January 3, 2011 - 3AM Eastern
-- CDC Hand Hygiene In Healthcare Settings Website --
-- Update On Steris System 1 and Criterion Newsletter --
-- Important Info from FDA on Steris System 1 Processor --
-- New Vendor Certification Page --
-- FDA: Ongoing Safety Review of Arthroscopic Shavers --
-- Joint Commission Revises Flash Sterilization Survey Standards --
In reviewing this method of sterilization, several issues have emerged including:
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
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:
For more information, please see the CDC/HICPAC guideline at this link:
Please feel free to submit any questions at the following web address:
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:
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.
On 4/10/09 at 9:16 AM Sheila Murphey responded:
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.
-- New Link from CDC --
-- New Instructional CD for Best Selling Textbook --
November 5, 2008 - 5 pm Eastern
**ATTENTION 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! --
-- New Office Policy --
-- 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.