Sterile water for injection

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I have a antibiotic that had to be reconstituted with sterile water. I did not have any on the unit and notified my supervisor. I was told that I can use any sterile water. I learned that there are different types based on usage that relates to the way they are prepared. I explained this to the supervisor but she told me I was wrong. Anyways I refused to use "any sterile water" for the IM injection. I have now been researching tonight and I am understanding from what I am reading that FDA labels sterile water based on what it is used for as this determines how it is produced. Am I understanding this correctly?

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Where I work, if a reconstitution requires sterile water then it is provided in the med dispenser with the medication.

But really, as long as it's sterile then any water should be acceptable for reconstitution. Unless it's calling for something specific like distilled water (which I've never seen).

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On 10/26/2019 at 10:38 PM, lunalee62 said:

I have a antibiotic that had to be reconstituted with sterile water. I did not have any on the unit and notified my supervisor. I was told that I can use any sterile water. I learned that there are different types based on usage that relates to the way they are prepared. I explained this to the supervisor but she told me I was wrong. Anyways I refused to use "any sterile water" for the IM injection. I have now been researching tonight and I am understanding from what I am reading that FDA labels sterile water based on what it is used for as this determines how it is produced. Am I understanding this correctly?

I'm no expert, but that's my understanding, too.

My unit stocks several variations of sterile water: tiny vials for med reconstitution, large bottles for wound irrigation, and formula-sized bottles for enteral feed preparation. The 'wound irrigation' bottles specifically state on the bottle 'not for IV use,' and the enteral bottles state, 'for enteral use only.' Yes, in theory they're all 'sterile water,' but there's no way I'm injecting someone with water from either of those sources.

I'm guessing it's either a preparation issue (i.e. the non-injection bottles aren't prepared in quite as sterile an environment as the injection-approved ones) or a testing issue (i.e. the FDA hasn't cleared reconstitution/injection by those sources).

It reminds me of an issue we had with our NS flushes. I work in NICU/peds, so when we give a saline bolus during a resuscitation, the volumes can be pretty tiny (10-50 mL). If you had to give a 30 mL NS bolus, many nurses were simply pushing 3 10-mL flushes. We got an email from our manager saying that we couldn't do that anymore because the flushes are only FDA approved for one purpose: as single-use flushes. Seems kind of silly (saline is saline, and both were rated for IV injection), but that was the official answer.

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That was an interesting question. What I have read supports your interpretation.

I found this reason for not using sterile water for irrigation:

"Sterile water for irrigation is NOT FDA labeled for any use as an injection in patients. Sterile water for injection, USP, must pass a particulate-matter test that sterile water for irrigation, USP, does not have to pass. "

https://www.ashp.org/-/media/assets/drug-shortages/docs/drug-shortages-sterile-water-faq.ashx

Also this:

"Sterile water for injection. This water has been packaged and rendered sterile. This water is for the processing of sterile products intended to be used intravenously. Additionally, it is used for other applications where bulk WFI or purified water is indicated but access to a validated water system is either not practical or only a relatively small quantity is needed. Sterile WFI is typically packaged in single-dose containers that are typically less than 1 L in size.

Sterile water for irrigation. This water has been packaged and rendered sterile. This water is commonly used when sterile water is required, but when the application does not have particulate matter specifications. Sterile water for irrigation is often packaged in containers that are typically greater than 1 L in size.

Sterile water for inhalation. This water has been packaged and rendered sterile. This water is usually intended for use with inhalators and in preparation of inhalation solutions. It carries a less stringent specification for bacterial endotoxins than sterile WFI and, therefore, is not suitable for parenteral applications.

http://www.pharmtech.com/understanding-usp-water-pharmaceutical-use

The FDA defines 8 types of water and requirements are different depending on the type of water.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-technical-guides/water-pharmacuetical-use

I didn't find any requirements for sterile water for enteral feeding.

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Just because the water is sterile does not mean that the the result, once mixed, will be sterile. I think packaging plays a role.

This is why only sterile NS flushes go on a sterile field. Both have the same exact ingredient, but they are packaged differently.

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Great question this turned out to be!

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