Education News!


New Podcast featuring Nancy Chobin can be found HERE as well as iTunes and Linked-in.


Update on Louisiana House Bill 748

About a month ago, the Louisiana House of Delegates passed House Bill 748, which banned the use of the term "certification" issued from professional credentialing bodies unless such certification is used in conjunction with licensure. ICE is now pleased to inform you that Louisiana House Bill 748 has been amended to address the concerns of the credentialing community! The concerning language regarding the use of the term "certified" was deleted entirely by amendment, and a subsequent amendment then deleted most of the bill. That amendment was adopted and now leaves us with a bill that reads as follows:

"Pursuant to the authority in this Chapter, the governor shall review on an annual basis not less than twenty percent of the agencies engaged in regulatory and licensing activities.  Within five years, the governor shall have reviewed all such agencies."

In addition, a related bill, HB 378, has been amended to remove all references to the term "certification," other than to say that "nothing shall be construed to restrict a licensing board from requiring, as a condition of licensure or renewal of licensure, obtaining/maintaining credentials from an organization that credentials individuals in the relevant occupation, field, or industry."

We are pleased with the outcome and resolution of the concerns raised by the credentialing community. We would like to thank our members as well as other organizations in our industry who collaborated in the rapid mobilization of a coalition and made a difference!  ICE and our partners at Pillsbury will continue to keep you informed of any new developments as these amended bills move forward to the Louisiana Senate.


Denise Roosendaal, CAE
ICE Executive Director


Nancy Chobin receives a 2018 AAMI Standards Developer Award

The award will be presented during the AAMI Awards Celebration at the 2018 Annual Conference in Long Beach, CA on Saturday, June 2nd.


FDA Clears First Duodenoscope with Disposable Distal Cap

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.


Pre-order AAMI ST-79 HERE!


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 ( 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.



The Basics of Flexible Endoscope Reprocessing, Second Edition is now available! This edition has been completely updated to include all the latest recommendations from the CDC, FDA, AAMI and SGNA. AAMI published an endoscope document called: Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities, ST-91, (2015). Recommendations from this document are included. The book has been expanded to 195 pages with a section on Signs and Symbols, a sample Competency Assessment form and many additional photos.

PLEASE NOTE: Questions from the second edition will NOT be on the May, August or November, 2016 Certified Flexible Endoscope Examination. They will be on the Certified Flexible Endoscope Examinations beginning February, 2017.

Get your copy NOW! Price is $95.00 plus shipping.

The companion Workbook for The Basics of Flexible Endoscope Reprocessing, Second Edition, is also available. There are 189 multiple choice practice questions including a 75 question practice Final Exam. Get your copy at the price of $20 plus shipping.




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.


Connecticut passes CS/SPD Certification Bill & AAMI Standard ST-91

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:
  • Successfully 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
  • Was 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 CBSPD; and
  • Must complete a minimum of 10 hours of continuing education annually related to the functions of a CS technician.
This 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.


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 to order a copy.


Recommendations for processing duodenoscopes used for ERCP procedures and more

Newest updates from the FDA/CDC. Click HERE!




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.


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

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.

Frequently Asked Questions: ASP STERRAD® CYCLESURE® 24 Biological Indicator (BI) (P/N 14324) Recall can be found HERE with this file to download.

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

Link 1 and Link 2.

June 18. 2011

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

August 17, 2010

A new paper written by the president of SPU and retired Executive Director of CBSPD, Nancy Chobin, on the costs of surgical instrument training can be found by clicking HERE.

-- CDC Hand Hygiene In Healthcare Settings Website --

June 4, 2010

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

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:

Please feel free to submit any questions at the following web address:

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