STERILE PROCESSING UNIVERSITY
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.
17th Annual Processing And Regulatory Issues in Sterilization
A Continuing Education Program for Personnel Performing Decontamination, Disinfection and Sterilization
Saturday, November 4, 2017
Co-Sponsored by and held at:
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire
REGISTRATION DEADLINE is October 27, 2017
Click HERE for a brochure.
Click HERE to register and pay on-line.
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.
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.
CLICK HERE TO ORDER!
New Management Course Dates/Locations now Available for 2016 with Nancy Chobin, RN, AAS, ACSP, CSPM!!!
Click HERE for details!
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!
New 5th Edition Technician Online Course is now available HERE!
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
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.
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 http://www.cdc.gov/handhygiene/index.html
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: