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
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
Warning issued on dosing of drug for primary biliary cholangitis
Clinicians should determine baseline liver function before starting patients on obeticholic acid, the FDA said.
https://gastroenterology.acponline.org/archives/2017/10/27/6.htm
27 Oct 2017
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
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
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
New treatment approved for complicated intra-abdominal infections
The three-drug combination injection contains imipenem-cilastatin, a previously FDA-approved antibiotic, and relebactam, a new beta-lactamase inhibitor.
https://gastroenterology.acponline.org/archives/2019/07/26/6.htm
26 Jul 2019