FDA and powdered formula

  1. Have any of you read the article the FDA just put out about not using powdered formula in the NICU setting? Apparently, and infant died from Enterobacter sakazakii meningitis related to being fed powdered Portagen. The FDA is now saying that powdered formulas should not be used in the NICU setting ...only liquid forms. They say that powdered formula is not commercially sterile and there processing differs from that of liquid formulas. They strongly suggest that powdered formulas not be used unless clinically required and under strict medical supervision. They also suggest that careful preparation and handling is essential. They suggest that aseptic techinique be used in preparing powdered formula and using sterile water. My question is....Have any of your NICU's addressed this issue and how are you doing things differently in regards to using powdered formula on your units? Our unit just addressed this....they are going to continue to use powder formula (we use it to increase calories of our liquid formulas and breastmilk) and we have to wear clean gloves when mixing formulas up.
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    About Nrse4bbs

    Joined: Apr '01; Posts: 6


  3. by   dawngloves
    So how would we get Nutramigen? Doesn't that only come powdered? And would that also apply to the use of HMF?
    We only use sterile water when mixing formulas anyway.
  4. by   Jolie

    The statement issued by the FDA recommended against the use of powdered formulas in the NICU if liquid alternatives were available. Those formulas that only come in powdered form will still have to be used with additional precautions. Apparently powdered formulas are not subjected to a heating process which would render them sterile, so it is possible for bacteria to grow in the dry powder. The article did not mention refrigerating the cans of powder as a possible means of retarding bacterial growth, but I wonder if it would help. Also, I am a firm believer that these formulas should be mixed by dietary or pharmacy and sent to the NICU every 12 hours, as it is difficult to maintain an aseptic environment within the NICU where formula can be properly prepared.

    The article suggested guidelines for minimizing the length of time that continuous feedings are allowed to "hang" since the formula is unrefrigerated and subject to more rapid bacterial growth. I don't think it mentioned powdered human milk fortifier, but I would guess that it is non-sterile as well, and subject to the same considerations.

    I'd be curious to hear what your NICUs are doing to address these problems.
  5. by   dawngloves
    formulas should be mixed by dietary or pharmacy and sent to the NICU every 12 hours, as it is difficult to maintain an aseptic environment within the NICU where formula can be properly prepared.
    Excellent idea!
  6. by   Nrse4bbs
    The whole formula preparation by the pharmacy was brought up in our hospital but, our pharmacy stated that they cannot bring an unsterile product into their sterile environment to prepare it. Hospital infection control believes that would create a risk because of other "sterile preparations" that are being mixed in the pharmacy. I don't know if this makes any sense but, the outcome of this was that the bedside nurses are now preparing the formula wearing clean gloves and each can is a one patient use.
  7. by   Jolie
    I don't buy pharmacy's arguement. I understand that their IV room is sterile, and would not be an appropriate site for formula preparation, but they prepare doses of unsterile oral meds in other areas of the pharmacy, so why not mix the formula there? Sounds like they just do not want to get involved, despite the potential risk to babies of having formula mixed in the unclean environment of the NICU, where diapers are changed, labs are drawn, and ET tubes are suctioned.

    I know that many units have formula preparation rooms or areas, but even this is not an adequate protection, as these rooms also contain handwashing sinks used by all staff members, and also tend to be the site of the unit coffee pot and snack area.

    If pharmacy won't budge, how about dietary? Never having cared for adults, I don't know about this, but does dietary prepare formulas for adult tube feedings or do they just come from a can?
  8. by   babynurselsa
    At another of the hospitals that I worked at the pharmacy did mix some of our feedings such as continious pump feedings. So I think this is a don't want to issue rather than a can't.
    Nutramigen does come liquid. Maybe someone needs to talk to your your Mead Johnson Rep to get some.
    I mentioned this to our Neo the other day when I saw the article here and he had heard nothing about it yet so I have printed off a copy to give him when he gets back from a conference.
    We use very little powdered formula, thankfully.
  9. by   NicuGal
    We only use ready to feed, and all of our special formulas are mixed by dietary. We don't use powdered at all on the unit.

    How long do you all hang your continous feeds for? Ours have a 4 hour hang time and then the syringe gets changed, the tubing is changed every 8 hours.
  10. by   Nrse4bbs
    We also have a 4 hour hang time with and 8 hour tubing change. I agree with all of you that the issue with the NICU that I work at is a don't want to get involved thing. It is the hot topic on the unit right now. The doctors are now all involved and they are going to discuss the issue at length.
  11. by   canoehead
    At a pediatric hospital I used to work at the dietary dept had a "formula room" where they could mix all strengths and types, then send up 24h worth at a time in sterile bottles to be stored in the fridge.
  12. by   nell
    Anybody have an update on this subject?

    Months ago, I showed the flier I got in the mail to our Neo and she was not at all concerned.

    Most of our kids are on breastmilk to which we add HMF or NeoSure powder (since this came out, each kid has his/her own can, but only one set of measuring spoons ). Most of our preemies are sent home on powdered NeoSure/NeoSure fortified breastmilk for those feeds that are not directly at the breast.
  13. by   nurseiam
    We have recently changed our practice because of this article. We now have premeasured addatives in little sterile cups like a prescription bottle (seems very expensive). I wish we had dietary mix the formula's. With 3 or 4 grower/feeders on BRM/formula with adds. it can take 1/2 and hour to mix them all! There was a great article in Neonatal Network a year or so ago that had a place where the parents checked in the BRM and 24 hrs. worth was mixed! One can dream........
  14. by   NicuGal
    We had a nurse from Canada visiting last week and they have a room, like a pharmacy that that is all they do is measure out feeds, add additives and make the special formulas. Your feedings come in the premeasured syringes, labeled with name, date. You get 24 hours worth of feeds, they never have to draw their own up! What a time saver!

    They call them the Dairy Queens :lol