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Gore launches anti-migration assurance program for Viabil stent
W.L. Gore & Associates said today it launched an Anti-Migration Assurance Program for its Viabil short wire biliary endoprosthesis through which it will provide replacement devices for patients whose device moves out of place within a year of implantation. The Flagstaff, Ariz.-based company said the short wire biliary endoprosthesis has an average migration rate of 0.2%, touting the device as being the only “fully covered metal stent with demonstrated low migration and high long-term patency.” “Reintervention with additional stents and additional procedures increases the patient’s risk of c...
Source: Mass Device - October 4, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Stents W.L. Gore & Associates Source Type: news

TSO3 files FDA app seeking duodenoscope indication for Sterizone VP4 sterilizer
TSO3 said today it filed a 510(k) application with the FDA as it seeks to clear its Sterizone VP4 sterilizer for the terminal sterilization of duodenoscopes used in endoscopic retrograde cholangio-pancreatography procedures. The company’s Sterizone VP4 is a low-temperature sterilization system which uses dual-sterilants of vaporized hydrogen peroxide and ozone for the terminal sterilization of heat and moisture sensitive medical devices. The system has a single pre-programmed cycle which can be used to sterilize a wide range of devices, the Quebec City-based company said. TSO3 said that if awarded, the approval would...
Source: Mass Device - July 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Sterilization / Calibration TSO3 Source Type: news

7 medtech stories we missed this week: June 23, 2017
[Image from unsplash.com]From Guardant suing Foundation Medicine to Interson receiving 510(k) clearance for ultrasound probes, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Guardant levels false advertising suit against Foundation Medicine Guardant Health announced in a June 22 press release that it has filed a lawsuit against Foundation Medicine for false advertising and unfair competition. Guardant Health is claiming that Foundation Medicine’s advertising causes harm to Guardant Health and its patients because it misleads oncologists about the sensitivity and accuracy of...
Source: Mass Device - June 23, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Business/Financial News Clinical Trials Food & Drug Administration (FDA) Implants Neurological Regulatory/Compliance Ultrasound EndoStim Foundation Medicine Inc. Guardant Health Interson Lee's Pharmaceutical Meditech Med Source Type: news

Cook Medical launches Acrobat 2 wire guide
Cook Medical said yesterday it launched the next-gen Acrobat 2 calibrated tip wire guide. The Acrobat 2 is designed to provide greater tip flexibility to aid in ductal navigation, the Bloomington, Ind.-based company said. “We’re very excited to launch the Acrobat 2 wire guide. We’ve engineered the Acrobat 2 wire guide to give you the optimal combination of tip flexibility and pushability whether you are facing a routine ERCP or a complex procedure. The Acrobat 2 wire guide gives you the tool you need for reliable access to deliver therapy throughout the biliary and pancreatic ducts,” Cook Medic...
Source: Mass Device - May 9, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Catheters Cook Medical Source Type: news

From Interventional Radiologist to Medtech CEO: Interview with Dr. Bob Smouse, Founder of BrightWater Medical
Welcome to the Medsider interview series, a regular feature at MassDevice. All interviews are conducted by Scott Nelson, Founder of Medsider and Group Director for WCG. We hope you enjoy them! Dr. Bob Smouse has over 20 years of experience in interventional radiology, endovascular surgery and clinical research. In addition to acting as CEO and CMO of BrightWater Medical and teaching at the University of Illinois College of Medicine, he provides interventional medical services to local hospitals through Central Illinois Radiology Associates. Dr. Smouse is a medical consultant and scientific advisory board mem...
Source: Mass Device - February 10, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Blog medsider Smouse Source Type: news

Fujifilm pulls older duodenoscopes after superbug outbreaks
Fujifilm Holdings (TSE:4901) said today that it will pull its legacy 250/450 duodenoscope models from clinical use and replace those devices with the ED-530XT model at no cost to its customers. The company said in a letter to its customers that the decision is not directly related to any safety concerns and that it has not received any recent reports of adverse events associated with the scopes. The FDA is continuing to investigate the link between reprocessed endoscopes and the transmission of infectious agents by working with duodenoscope manufacturers as they incorporate new techniques to a...
Source: Mass Device - January 13, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Endoscopic / Arthroscopic Food & Drug Administration (FDA) Hospital Care Regulatory/Clearance Wall Street Beat Fujifilm Holdings Source Type: news

Putting Out the'Fire' of Post-ERCP Pancreatitis Putting Out the'Fire' of Post-ERCP Pancreatitis
Does the aggressive use of intravenous fluids have a role in preventing pancreatitis after endoscopic retrograde cholangiopancreatography?Medscape Gastroenterology (Source: Medscape Gastroenterology Headlines)
Source: Medscape Gastroenterology Headlines - December 5, 2016 Category: Gastroenterology Tags: Gastroenterology Viewpoint Source Type: news

Less Post-ERCP Pancreatitis With Lactated Ringer's Plus Rectal Indomethacin Less Post-ERCP Pancreatitis With Lactated Ringer's Plus Rectal Indomethacin
Infusion of lactated Ringer's solution along with rectal administration of indomethacin was associated with lower rates of post-ERCP pancreatitis (PEP) in a randomized, placebo-controlled trial.Reuters Health Information (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - December 1, 2016 Category: Surgery Tags: Gastroenterology News Source Type: news

ECRI lists the top 10 medical device hazards
The ECRI Institute this month released its top 10 health technology hazards for the next year, with Infusion errors and inadequate cleaning of reusable instruments topping the list. 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. The institute nailed large-volume infusion pumps as its largest hazard, saying that despite improved safety features, the mechanisms have been “known to fail” and can lead to patient harm or even death. Issues with the pumps included administration set failu...
Source: Mass Device - November 8, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Hospital Care ECRI Institute Source Type: news

Hydration in the Prevention of Post-ERCP Pancreatitis Hydration in the Prevention of Post-ERCP Pancreatitis
Post-ERCP pancreatitis is the most frequent complication of ERCP. Is periprocedural hydration effective as a preventive measure?Alimentary Pharmacology & Therapeutics (Source: Medscape Radiology Headlines)
Source: Medscape Radiology Headlines - October 6, 2016 Category: Radiology Tags: Gastroenterology Journal Article Source Type: news

Endoscopic Ultrasound-Guided Drainage Effective After Failed ERCP Endoscopic Ultrasound-Guided Drainage Effective After Failed ERCP
Endoscopic ultrasound (EUS)-guided pancreatic drainage is effective for pancreatic strictures after failed ERCP, according to results from an international study.Reuters Health Information (Source: Medscape Radiology Headlines)
Source: Medscape Radiology Headlines - August 29, 2016 Category: Radiology Tags: Radiology News Source Type: news

FDA warns on using Custom Ultrasonics device on duodenoscopes
The FDA today reiterated its warning not to use the an automated endoscope reprocessor made by Custom Ultrasonics with a type of ‘scope called duodenoscopes, which have been linked to deadly “superbug” outbreaks. Although the federal safety watchdog lifted the recall on Custom Ultrasonics’ endoscope reprocessors while the company looked to correct the violations that prompted the recall, the FDA said again today that the System 83 Plus devices should not be used with duodenoscopes. The devices are used for a procedure called endoscopic retrograde cholangiopancreatography, in...
Source: Mass Device - August 17, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Endoscopic / Arthroscopic Food & Drug Administration (FDA) Regulatory/Compliance Custom Ultrasonics Source Type: news

Rectal Indomethacin Does Not Prevent Post-ERCP Pancreatitis Rectal Indomethacin Does Not Prevent Post-ERCP Pancreatitis
New research finds that prophylactic rectal indomethacin does not reduce incidence of post-ERCP pancreatitis. Should published guidelines be reconsidered? Gastroenterology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - July 27, 2016 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

Experts emphasize scrupulous procedures for duodenoscopes, ERCP
Contaminated duodenoscopes have caused multiple outbreaks of multidrug-resistant infections with sometimes lethal consequences; until these instruments become easier to clean, personnel must strictly... (Source: Family Practice News)
Source: Family Practice News - July 13, 2016 Category: Primary Care Source Type: news

Indomethacin May Curb Pancreatitis After ERCPIndomethacin May Curb Pancreatitis After ERCP
Rectal indomethacin may cut the risk of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in a wide range of patients, suggests a new study. Reuters Health Information (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - June 7, 2016 Category: Surgery Tags: Gastroenterology News Source Type: news

FDA Follies, Part 2
Part 1 of this series appeared just over a year ago (in a different publication), and detailed a few of the agency's recent missteps. Prominently mentioned was the sad case of certain diabetes meds, including Actos, once touted as a safer alternative to Avandia. Avandia was taken off the market in 2011, but reappeared subject to severe limitations of use. These limitations were later removed—although current usage of the drug is small. Oddly, Actos (FDA approved in July, 1999) was showing some problems (bladder cancer) as early as 2005, even though this information was not widely disseminated at the time. Some migh...
Source: Healthy Living - The Huffington Post - May 17, 2016 Category: Consumer Health News Source Type: news

Precut Sphincterotomy Does Not Increase Risk During ERCPPrecut Sphincterotomy Does Not Increase Risk During ERCP
The use of precut sphincterotomy was not associated with an increased risk of postoperative pancreatitis in patients with difficult biliary access, a new study reports. Clinical Gastroenterology and Hepatology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - April 11, 2016 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

Rectal indomethacin does not prevent pancreatitis post ERCP
Patients who receive rectal indomethacin after undergoing endoscopic retrograde cholangiopancreatography (ERCP) are not any less likely to develop pancreatitis than individuals who don’t, according... (Source: Family Practice News)
Source: Family Practice News - April 1, 2016 Category: Primary Care Source Type: news

Chronic pancreatitis: Bently says he’s ‘ready for a new belly’
  Bently Barnes (center) with Dr. Victor Fox and Dr. Amit Grover, co-directors of the Pancreatic Disorders Program Four-year-old Bently Barnes needed to get ready. He opened the closet door, reached for his camouflage backpack, then scanned his bedroom for the essentials. He grabbed his favorite stuffed animal named, “Marshall,” a truck, tractor and his most prized possession – his blanket. He placed them in his backpack with care, zipped the travel bag and placed it next to his bed. Bently told his mom he was packed and ready to travel from their home in North Carolina to Boston ...
Source: Thrive, Children's Hospital Boston - March 25, 2016 Category: Pediatrics Authors: Maureen McCarthy Tags: Diseases & Conditions Our Patients’ Stories Amit Grover Chronic pancreatitis ERCP MD Pancreatic Disorders Program Second opinion Victor Fox Source Type: news

Olympus updates reprocessing instructions for Duodenoscopes
The FDA yesterday released updated reprocessing instructions it received from Olympus (TYO:7733) in relation to its TJF-160F and TJF-160VF duodenoscopes. Olympus has been working on refining its reprocessing instructions since March last year, the FDA said, and only in January did the agency clear the updated reprocessing models as adequate. The updated reprocessing instructions include a more rigorous pre-cleaning protocol, manual cleaning and high-level disinfection procedures including additional flushing, brushing and increased flushing volume, according to an FDA safety communication. Olympus sent a letter, dated...
Source: Mass Device - March 16, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Endoscopic / Arthroscopic Food & Drug Administration (FDA) Sterilization / Calibration Olympus Source Type: news

Pentax updates on FDA-cleared scope labeling to fight “superbugs”
The FDA said it cleared updated reprocessing instructions for Pentax’s ED-3490TK video duodenoscopes to avoid infectious outbreaks of “superbugs.” Duodenoscopes 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 than 500,000 ERCPs using the devices are performed in the U.S. annually. Duodenoscopes are an FDA-identified culprit in a string of “superbug” outbreaks, due to the complex designs of the devices impeding cleaning and processing, leaving residual body fluids and organic...
Source: Mass Device - February 19, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Endoscopic / Arthroscopic Food & Drug Administration (FDA) Pentax Source Type: news

Olympus' TJF-Q180V Duodenoscope Receives 510(k) Clearance
FDA has cleared the 510(k) for Olympus' TJF-Q180V duodenoscope with modifications to the device design and labeling. The duodenoscope is a flexible gastrointestinal endoscope used in procedures such as endoscopic retrograde cholangiopancreatography (ERCP), which is most commonly performed to diagnose and treat conditions in the pancreas, bile duct and gallbladder. (Source: Medical Design Online News)
Source: Medical Design Online News - January 19, 2016 Category: Medical Equipment Source Type: news

UPDATE – Preventing superbugs: FDA clears redesigned Olympus endoscope
Updated to include information from Olympus. The FDA today said it cleared a redesigned version of Olympus‘ (TYO:7733) TJF-Q180V duodenoscope, with modifications intended to reduce the risk of bacterial infections. The company said it won new 510(k) clearance for the TJF-Q180V model, for modifications to both the design and labeling of the device. The redesigned endoscope from Olympus comes on the heels of a new report from the U.S. Senate’s health committee, which slapped blame on medical device companies and hospitals for deadly outbreaks of so-called “superbug” infections linked to the scopes. Du...
Source: Mass Device - January 15, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Endoscopic / Arthroscopic Food & Drug Administration (FDA) Imaging Olympus Source Type: news

Senate report faults hospitals, device makers, FDA for deadly ‘superbug’ outbreaks
A report by Democrats on the U.S. Senate’s health committee issued this week blames hospitals, medical device companies and the FDA for the deadly outbreaks of so-called “superbug” infections linked to duodenoscopes. 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 than 500,000 ERCPs using the devices are performed in the U.S. annually. Hospitals in Connecticut, Virginia, California and Washington state all reported superbug outbreaks in February and March 2014, some of which led ...
Source: Mass Device - January 14, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Endoscopic / Arthroscopic Capitol Hill Fujifilm Holdings Hoya Corp. Olympus Pentax Source Type: news

What Are Risk Factors for Cholelithiasis?
Discussion Bile is produced by the liver to aid absorption of fat soluble vitamins and lipids from the gastrointestinal tract and to transport bilirubin, cholesterol and other substances to the gastrointestinal tract. Bile is the main form of cholesterol excretion. Gallstones or cholelithiasis form when the balance of substances within the hepatobiliary tract favors supersaturation with crystal formation and gallstone formation. It is a dynamic state of affairs as gallstones can form and also have a high rate of resorption of up to 50%. Gallstones 3 mm are called gallstones. Gallstones, while not as common as adult popula...
Source: PediatricEducation.org - January 4, 2016 Category: Pediatrics Authors: pediatriceducationmin Tags: Uncategorized Source Type: news

FDA clears FujiFilm reprocessing label for ’superbug’-susceptible duodenoscopes
The FDA last week said it cleared Fujifilm Holdings‘ (TSE:4901) revised manual reprocessing instructions for its ED-530XT duodenoscope, replacing reprocessing instructions included on the original device label. Duodenoscopes 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 than 500,000 ERCPs using the devices are performed in the U.S. annually. While the reprocessing instructions were specific for the ED-530XT, the FDA urged health care facilities to use the reprocessing instructions for FujiFilm’s...
Source: Mass Device - December 28, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Imaging Fujifilm Holdings Source Type: news

Terumo expands Olympus Glidewire distro deal to include endo wire
Terumo Corp. (TYO:4543) said today it’s expanding its distribution partnership with Olympus (TYO:7733) to include its Glidewire endoscopic hydrophilic coated guidewire designed for endoscopic treatment of the biliary and pancreatic systems. Olympus will be the exclusive distributor in the U.S. for Terumo’s device effective immediatley. The guidewire is designed for gastroenterological procedures as a complement to imaging and therapeutic devices Olympus offers through its EndoTherapy division. “I have used the Glidewire for ERCP and for complex advanced endoscopic procedures for more than 20 years. I...
Source: Mass Device - December 15, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Endoscopic / Arthroscopic Business/Financial News Catheters Distribution Olympus Terumo Source Type: news

Olympus recalls select endoscopes over heat issue
Olympus (TYO:7733) said today it is initiating a select recall of its EndoEye HD II endoscopes over issues with damaged temperature sensors causing the distal ends of the device to become ‘abnormally hot’. The devices are used during endoscopy and endoscopic surgeries along with other tools within the thoracic and abdominal cavities, including the female reproductive organs, the company said. Olympus said it has not received any reports of injuries from the malfunction, but that the malfunction could result in patient or user injury if not corrected. The select recall affects model numbers WA50040A an...
Source: Mass Device - December 8, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Endoscopic / Arthroscopic Recalls Olympus Source Type: news

From finger painting to Boston Children’s for acute pancreatic care
Three-year-old Brooklyn loves to get her hands dirty. When it comes to playtime this spunky and vivacious toddler shies away from tiaras and princess garb and heads straight for her overalls. “Brooklyn is adventurous, curious, and loves dirt, mud and paint,” said Kristen, Brooklyn’s Mom. “We have an art room, and she has a blast with paint in there.” Though the tiny finger painter and mud-pie maker loves all-things mucky, her passion for excavation and exploration was recently put on hold. Soon after Brooklyn’s third birthday, sudden bouts of intense stomach pain and vomiting became...
Source: Thrive, Children's Hospital Boston - November 24, 2015 Category: Pediatrics Authors: Maureen McCarthy Tags: All posts Our patients’ stories Dr. Victor Fox Pancreatic Disorders Program pediatric acute pancreatitis Source Type: news

FDA orders recall of all Custom Ultrasonic endoscope reprocessors
The FDA today ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors over “continued violations of federal law and a consent decree entered with the company in 2007.” The agency said the violations could result in an increased risk of infection transmission. The FDA said that the recall was under terms of the consent decree, and it issued a safety communication to urge health care facilities using the devices to transition to alternative methods for scope reprocessing as soon as possible. The recall affects an estimated 2,800 AERs manufactured by Custom Ultrasonics in use in healthcare...
Source: Mass Device - November 13, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Endoscopic / Arthroscopic Food & Drug Administration (FDA) Recalls Regulatory/Compliance Custom Ultrasonics Source Type: news

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 cam...
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 moth...
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 cholangiopancreatog...
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), Fujifil...
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

Pharmacological Prophylaxis Against Post-ERCP PancreatitisPharmacological Prophylaxis Against Post-ERCP Pancreatitis
What can clinicians prescribe in an attempt to prevent post-ERCP pancreatitis? Alimentary Pharmacology & Therapeutics (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - December 18, 2013 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

Diagnosing and Treating Pancreatic DiseaseDiagnosing and Treating Pancreatic Disease
Can most pancreatic diseases and malignancies be effectively managed with ERCP and/or EUS-FNA? This new study investigates. Current Opinion in Gastroenterology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - September 13, 2013 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

Rectal Indomethacin and Pancreatic Stents in High-Risk ERCPRectal Indomethacin and Pancreatic Stents in High-Risk ERCP
Do patients undergoing high-risk ERCP benefit from rectal indomethacin, or are prophylactic pancreatic stents still considered necessary? The American Journal of Gastroenterology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - May 23, 2013 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news