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...
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 Children’s Hospital. ...
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 for...
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 debris ...
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.
Duoden...
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 popul...
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 250...
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 fin...
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 and WA5004...
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 frequent.
“She vomite...
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
