Search results for "FDA update"
Incontinence management system recalled due to potential interference with other devices
About a month after issuing an urgent medical device correction, the manufacturer announced a class I recall of the WatchCare Incontinence Management System due to potential radio frequency interference with other medical devices.
https://gastroenterology.acponline.org/archives/2022/12/23/8.htm
23 Dec 2022
Urgent medical device correction for incontinence management system
There is a potential for radio frequency interference between the WatchCare Incontinence Management System and other medical devices in the vicinity, such as insulin pumps, telemetry devices, and infusion injection pumps.
https://gastroenterology.acponline.org/archives/2022/11/18/10.htm
18 Nov 2022
FDA limits packaging for loperamide to encourage safe use
To help address abuse and misuse, the FDA approved changes to the packaging for tablet and capsule forms of the over-the-counter antidiarrheal drug.
https://gastroenterology.acponline.org/archives/2019/09/27/8.htm
27 Sep 2019
Patient dies after fecal microbiota transplantation
One immunocompromised patient died and another was infected after receiving fecal microbiota for transplantation that contained multidrug-resistant bacteria, the FDA reported.
https://gastroenterology.acponline.org/archives/2019/06/28/6.htm
28 Jun 2019
Probiotics recalled due to bacterial contamination
A company recently recalled two lots of liquid probiotics due to the possibility of contamination with Pseudomonas aeruginosa.
https://gastroenterology.acponline.org/archives/2021/12/17/9.htm
17 Dec 2021
Use duodenoscopes that are fully disposable or have disposable components, FDA recommends
Interim results from one duodenoscope model with a removable component showed a contamination rate of 0.5%, compared with as high as 6% among older duodenoscope models, an FDA safety communication noted.
https://gastroenterology.acponline.org/archives/2022/04/22/11.htm
22 Apr 2022
FDA sends warning to duodenoscope manufacturers
The manufacturers have not fulfilled requirements to conduct studies assessing the real-world effectiveness of device reprocessing, the FDA said.
https://gastroenterology.acponline.org/archives/2018/03/23/6.htm
23 Mar 2018
Warning on risks of serious adverse events with use of fecal microbiota for transplantation
Several patients who have received fecal microbiota for transplantation from a U.S.-based stool bank have developed serious or life-threatening infections caused by pathogenic bacteria.
https://gastroenterology.acponline.org/archives/2020/03/27/9.htm
27 Mar 2020
Ulcerative colitis medicine may increase risk of serious heart-related problems, cancer
Preliminary results from a safety clinical trial indicate that tofacitinib may be associated with an increased risk of serious heart-related events and cancer compared to tumor necrosis factor inhibitors.
https://gastroenterology.acponline.org/archives/2021/02/26/8.htm
26 Feb 2021
HCV drug approved as 8-week regimen
The combination drug is indicated to treat all treatment-naive adults and some children who have chronic hepatitis C virus (HCV) genotypes 1 through 6 infection, either without cirrhosis or with compensated cirrhosis.
https://gastroenterology.acponline.org/archives/2019/10/25/7.htm
25 Oct 2019