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njdcgirl
member
WWSAIFD? Need advice re: medical records
njdcgirl
member
Warning: NOT SHORT! but I think writing out the whole story will help me. Bottom line - would you share your child's medical records to help with an FDA investigation?
Most of you know that Andrew spent 21 weeks in the NICU, after being born just short of 24 weeks last June. He was set to go home soon after his due date, but then had a setback. He was lethargic, wouldn't finish his bottles and threw up a few feeds. DH and I were concerned, and when we raised our fears with the Neonatologist he ordered bloodwork and an abdominal xray. What they found was scary - severely dialated intestines, wonky b/w, and possible indications of NEC - one of the most serious preemie issues (many of you will remember that Million$baby lost her Annaleigh to NEC). Luckily, we caught what ever was wrong early, and with 7 days of heavy antibiotics and no feeding, he slowly got better.
Andrew was never formally diagnosed with NEC, and at the time everyone was kind of surprised about his symptoms, b/c NEC usually strikes very young micropreemies in the NICU who are just beginning feeding. Andrew was past his due date at that point, almost 7 pounds, and about to be discharged. We came to find out about a month later (on Christmas eve no less) that three other "full term" preemies had come down with NEC since Andrew was discharged, and that two of them didn't make it. We "knew" both families - one was a 25 weeker who was literally going to be discharged the next day when she came down with it and died within 24 hours, and the other was a 34 week triplet who had been home for about a week when he got it, and passed away 2 weeks later after multiple surgeries. Tragic. When we found this out, of course we were shaken up, and were adviced by one of our former nurses to stop using a formula thickener that Andrew had been on for months. Apparently, this was one common denominator between all the sick babies - they had all been on thickened feeds with this product.
Needless to say, we stopped the thickener (changed to rice cereal until he was cleared to not need thickened feeds) and again said a prayer of thanks that Andrew was ok. Fastforward to a few weeks ago, the FDA released a warning that the product (Sim.plyThick) should not be used with preemies, b/c over 16 cases of NEC had been reported around the country the past few months in older preemies.
I got a call last week from the FDA - my name had been provided to them because I had bought some of the thickener from Sim.plyThick website and when I told them our story they came out to talk with me and get an affidavit about what happened with Andrew to help their investigation. I had no problem sharing his story, and what happened.
Finally to my question ==> Now, they want me to release his NICU medical records to them to use in their investigation. While I want to help in any way possible (of course I don't want this product to cause harm to any more babies if it is indeed the issue) I feel a little hesitant to do this. Andrew was in the hospital for 147 days, and has had several other visits there since discharge for appointments and his hernia surgery. Many (most) of his days there have absolutely nothing to do with this case and I just feel like there is no need for all his "business" to be out there in the hands of the government. (Records of his surgeries, brain bleeds, etc.) The release form they want me to sign is very generic - no specific hospital named, no dates or indication of what specific records should be released. Based on this, I know the hospital will just give them everything.
What would you do? I need to make a decision soon, I told her I'd speak with her on Monday with my answer. I think I want to do it, but help me feel ok about this! (or, talk sense into me otherwise!)
Thanks for anyone who made it through my book....I appreciate all thoughts!
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Re: WWSAIFD? Need advice re: medical records
I would probably do it, but I get your concerns. I would just tell her you will allow her to have all records from the incident and shortly before. She if she gives you any reason that she really needs the entire medical record. You should be able to alter the release or get a different one and list specific dates, etc.
Good luck, I wonder if it was a contaminated batch or something.
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Wow.....just wow. Thank God Andrew was one of the lucky ones.
I think I would give them the records. I get your concerns, but I think its important for them to get the big picture of it all.
BTW: Are you guys looking into a lawsuit? That's f'n unbelievable.
Yes, I would absolutely release it - all of it. There might be additional information they need in the full record to compare to other cases, or to see if there are other triggering events, or certain factors in common between the babies this has impacted.
If you're concerned, I would ask your contact if they will remove Andrew's name from the medical records. That way they get the information, but his name isn't attached to it.
This. I would absolutely release it. I think you can't get the full picture without everything, because how can you know what is related without seeing it all?
Yes, I would do it.
I totally understand your concerns, but whoever is running the investigation are most likely people who do this all the time, so confidentiality is already a part of what they do. Your information is not going to be leaked to others.....only to aid in the help of this particular investigation.
I would definitely want to help!
I would do it, and here's why.
What if my child was the one who could benefit from potentially life saving information, but it was not released??
I would do anything I could to help another family in that situation.
If it makes you more comfortable, ask that his name be removed from the records...surely they can do that?
Thanks ladies. I know it is the right thing to do. I just wanted to make sure I wasn't missing something legal-wise that would make it stupid to do this.
I'll ask about redacting his information.
As for the poster that mentioned a bad batch - this is what we were wondering too. The hospital had used the product for years with no issues at all, then all these cases at once. Makes you wonder.