In the last few days, I have seen two potentially serious recall alerts from the FDA; a mix up in labeling between Amiodarone HCl Injection and Tranexamic Acid Injection as well as a Class I recall due to hardware issues for BD Alaris System infusion pumps.
How solid is your process regarding being informed of the recall and for taking action to check your stock for the affected lot numbers? Is there a person within your facility responsible for recalls? Do you have a back up when that person is out of office?
I have seen cases where there is no back-up person, so when the person responsible returns from a vacation they have to catch up on recalls. Not what you want, especially for a Class I recall. Do you have a system to keep track of what you have done to ensure the affected lot was not present in your facility or if it was that it was removed from the shelves and sequestered? I have seen systems where there is only documentation if something is found making it appear nothing at all was done to check for items that were not found on site. It is important to log action taken, even if no affected lots were found on site (!). As a Director of Pharmacy, how solid is your oversight of the person assigned to recalls? Does another department have responsibility for recalls on pumps and if so, how confident are you that they are thorough? These are just a few things to think about.
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