ECRI Institute publishes top 10 health tech hazards, endo-superbugs top list
The ECRI Institute published a top 10 list of health technology hazards for 2016, focused on medical devices and issues that were of concern to patient safety.
The ECRI institute is a nonprofit dedicated to analyzing and researching which medical procedures, devices, drugs and processes are best to improve patient care, the group said.
Topping the list was inadequate cleaning of flexible endoscopes before disinfection, the ECRI Institute said, a problem that is not unknown to regulatory groups such as the FDA.
In August, the FDA published warning letters it sent to the 3 largest endoscope makers in the U.S. market over vio...
Source: Mass Device - November 12, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Hospital Care ECRI Institute Source Type: news
FDA orders ‘scope makers to launch postmarket studies
The FDA today ordered a trio of Japanese duodenoscope makers to run post-market surveillance studies to evaluate how the devices are reprocessed in real-world conditions, after a deadly rash of so-called “superbug” outbreaks this year were linked to the devices.
The string of deadly infections were attributed to duodenoscopes made by Olympus (TYO:7733), Fujifilm Holdings (TSE:4901) and Hoya‘s (TYO:7741) Pentax subsidiary. The devices are used for a procedure called endoscopic retrograde cholangiopancreatography, in which a reusable tube-like camera is inserted into the throat of a patient. More t...
Source: Mass Device - October 5, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Endoscopic / Arthroscopic Food & Drug Administration (FDA) Regulatory/Compliance Fujifilm Holdings Hoya Corp. Olympus Pentax Source Type: news
FDA updates bronchoscope cleaning guidelines
The FDA released new guidelines today for cleaning and reprocessing flexible bronchoscopes to prevent infections associated with improperly cleaned units.
Bronchoscopes must undergo reprocessing between uses, with broncoschopes specifically positioned to “pose a greater likelihood of microbial transmission and represent a high risk of infection if they are not adequately reprocessed,” according to the FDA.
The new guidelines, meant to avoid outbreaks of infections that can spread hospital-wide, include strict adherence to manufacturer reprocessing instructions. The Agency said it was critically important that a...
Source: Mass Device - September 17, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Sterilization / Calibration Source Type: news
Superbug victim’s family sues Pentax
The family of a Renate Winkler, who died due to a “superbug” infection transmitted by a duodenoscope, said Tuesday they are suing both the treating hospital and Pentax Medical, who manufactured the scope, for wrongful death.
Winkler died from a carbapenem-resistent enterobacteriacea infection, which is highly resistant to antibiotics, following an endoscopic retrograde choloangiopancreatography procedure at the Advocate Lutheran General hospital, according to the law firm Lieff Cabraser Heimann & Bernstein.
“No other families should have to go through what we did with the tragic death of our mother f...
Source: Mass Device - September 4, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Imaging Legal News Pentax Source Type: news
Infections Associated with Reprocessed Duodenoscopes (Updated)
Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum). They are used during endoscopic retrograde cholangiopancreatography (ERCP), a potentially life-saving... (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 17, 2015 Category: Medical Equipment Source Type: news
FDA updates endoscope cleaning guidelines after deadly superbug outbreaks
(Reuters) — Hospitals that can afford it should take steps beyond those recommended by the manufacturer to clean and disinfect a type of device at the center of a recent superbug outbreak in the U.S., health regulators said yesterday. Healthcare facilities that use duodenoscopes should meticulously follow the manufacturer’s cleaning instructions, the agency said in a safety update. Those with resources should also take several other measures to reduce the risk of infection.
Duodenoscopes are flexible, lighted tubes inserted down the throat during a procedure called endoscopic retrograde cholangiopancreatography (E...
Source: Mass Device - August 5, 2015 Category: Medical Equipment Authors: MassDevice Tags: Food & Drug Administration (FDA) Regulatory/Compliance Arthroscopic Source Type: news
FDA: 142 Reports Of Tainted Duodenoscopes Since 2010
The FDA recently disclosed more reports related to contaminated duodenoscopes used in endoscopic retrograde cholangiopancreatography (ERCP) procedures. (Source: Medical Design Online News)
Source: Medical Design Online News - May 12, 2015 Category: Medical Equipment Source Type: news
Olympus Validates New Reprocessing Instructions for Model TJF-Q180V Duodenoscopes
As noted in FDA?s February 2015 Safety Communication, the complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable... (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 26, 2015 Category: Medical Equipment Source Type: news
Updated Infections Associated with Reprocessed Duodenoscopes
Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum). They are used during endoscopic retrograde cholangiopancreatography (ERCP), a potentially life-saving... (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - March 13, 2015 Category: Medical Equipment Source Type: news
FDA: Physicians Shouldn't Cancel ERCP Procedures (FREE)
By Kristin J. Kelley
Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS
The FDA says that it is not necessary for physicians to cancel endoscopic retrograde cholangiopancreatography (ERCP) procedures with one specific model of duodenoscope that's in use without the proper clearance for marketing. There is no evidence that … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - March 6, 2015 Category: Primary Care Source Type: news
Don't Cancel ERCP Procedures for Patients in Need, FDA SaysDon't Cancel ERCP Procedures for Patients in Need, FDA Says
The FDA has responded to inquiries from health providers about whether they should cancel ERCP procedures in wake of an outbreak of drug-resistant infections linked to duodenoscopes. Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - March 5, 2015 Category: Consumer Health News Tags: Gastroenterology News Source Type: news
FDA warns on ERCP endoscope, CRE "superbug" link
The FDA warns ERCP endoscopes may allow for the transmission of certain drug-resistant "superbugs," even if the devices are properly cleaned.
The FDA is warning that ERCP endoscopes may allow for the transmission of certain drug-resistant "superbugs," even if the devices are properly cleaned.
The advisory was issued in the wake of news that contaminated endoscopes are suspected of causing a deadly outbreak of the superbug CRE, or carbapenem-resistant enterobacteriaceae (CRE), among patients at the UCLA Ronald Reagan Medical Center in Los Angeles.
Food & Drug Administration (FDA), Fujifilm Medical Sy...
Source: Mass Device - February 20, 2015 Category: Medical Equipment Authors: Val Kennedy Source Type: news
Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes: FDA Safety Communication - Design May Impede Effective Cleaning
Patients may be exposed to serious infections. (Source: FDA MedWatch)
Source: FDA MedWatch - February 19, 2015 Category: American Health Source Type: news
Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication
The FDA wants to raise awareness among health care professionals, including those working in reprocessing units in health care facilities, that the complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing... (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 19, 2015 Category: Medical Equipment Source Type: news
Notes from the Field: New Delhi Metallo-β-Lactamase–Producing Escherichia coli Associated with Endoscopic Retrograde Cholangiopancreatography — Illinois, 2013
(Source: CDC Morbidity and Mortality Weekly Report)
Source: CDC Morbidity and Mortality Weekly Report - January 3, 2014 Category: American Health Source Type: news
