STERILE PROCESSING UNIVERSITY
New Podcast featuring Nancy Chobin can be found HERE (Part I) and HERE (Part II) 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 (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.
NEW GI SCOPE TEXTBOOK & WORKBOOK AVAILABLE FOR SALE NOW!!!!!!!!!!!!!
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.
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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.
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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:
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
Newest updates from the FDA/CDC. Click HERE!