By: Lorraine Mazurek, Your Solutions Now LLC
A majority of Pregnancy Medical Centers and Pregnancy Resource Centers provide material assistance to patients/clients in the form of:
- Baby Food
- New Car Seats
- New Cribs, etc.
Material assistance is such a blessing to all of your patients/clients that receive them. However, what you didn’t know is you are at risk if you aren’t adhering to FDA requirements.
The FDA (Food and Drug Administration) requires anyone that provides food, equipment, etc., must register with the FDA Recall System and have policies in place for those items that are recalled.
As a consultant, I have all of my PMC clients register for recalls atwww.fda.gov. I ask them to sign up for recalls of food, drugs, medical devices, etc., via email. If you do receive notice of a recall of something you have in stock, you will have to follow your policies and procedures to address the issue.
The other FDA requirement is you “log” formula, baby food, etc., to ensure you discard any items that may be expired. There have been several instances when I do an onsite assessment that I find several items that have expired.
**If you do not implement the above and you give a patient/client any recalled items, you are legally responsible for an adverse event that may occur**
- Designate one or two people to sign up for recalls of food, medical devices, cleaning supplies, drugs, etc., at www.fda.gov.
- Develop or obtain FDA Recall Policies and Procedures to be placed in your Medical Policy Manual
- o Have your Medical Director review and approve the new Policies and make a recommendation to the Board of Directors to approve the new Policies.
- o Board of Directors approves the new Policies
- o Personnel are trained in the new Policies
- o Implementation of new Policies
For the Recall Policies and Procedures and Log Sheet, please contact Lorraine Mazurek at