Still a very puzzling communication from BD and very little helpful info from them or the FDA. It would be helpful to have clear insights on the 0.3% value and what the exposure may be for various therapies. How do you reconcile the multilayer PE lining focused insights to the multiple products that were in the advisory? (Gravity and blood tubing; extension sets, filters, burettes- all impacted).
Really appreciated the article. I feel that there is a institution that is uniquely designed to study this and provide us usable information- USP. Consistently disappointed their recommendations are rarely evidence based or studied in house. This is another safety compounding issue that is often discussed or debated but until real diligent studies are conducted there will be mass differences in practice. Or even worse, their may be standardization based on theory alone.
Still a very puzzling communication from BD and very little helpful info from them or the FDA. It would be helpful to have clear insights on the 0.3% value and what the exposure may be for various therapies. How do you reconcile the multilayer PE lining focused insights to the multiple products that were in the advisory? (Gravity and blood tubing; extension sets, filters, burettes- all impacted).
Really appreciated the article. I feel that there is a institution that is uniquely designed to study this and provide us usable information- USP. Consistently disappointed their recommendations are rarely evidence based or studied in house. This is another safety compounding issue that is often discussed or debated but until real diligent studies are conducted there will be mass differences in practice. Or even worse, their may be standardization based on theory alone.
agree, interestingly, from what I can gather there are neither USP or ISO standards that this would fall under.