Here’s what you should know.
1. The FDA issued the recommendation over the duodenoscopes only. The flexible endoscopes are not included because they’re easier to sterilize.
2. Custom is the subject of controversy as lawsuits are being filed against the manufacturer over claims the not properly disinfected duodenoscopes have delivered infections.
3. Custom issued an urgent medical device recall in May for the System 84 plus washer in regards to the duodenoscopes.
4. The FDA has filed several violations for violating good manufacturing practices against Custom in 1992, 1995, 2005 and 2006.
5. The FDA has recalled the System 83 machine two times in the past, but has rescinded the recall in both instances.
More gastroenterology and endoscopy news:
AGA hosts advocacy day to encourage MACRA oversight: 3 notes
Dr. Milena Bogunovic receives $100k award for IBD research: 3 notes
Galmed Pharmaceuticals names Dr. Liat Hayardeny chief scientific officer: 3 notes
