USP 797

[Sparda29]

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Can someone tell me what is actually allowed into the IV hood with you? I've been told I can't bring pens in there, or IV labels for the products, or the IV log.

When I'm drawing up a dose, I usually draw up a little extra and then dump the extra onto the IV hood work area since they don't allow graduated cylinders in there either. Of course I wipe it down with alcohol, but apparently even cleaning it out with regular alcohol isn't allowed. Since when can you ONLY use those sterile alcohol wipes.

 

[WVUPharm2007]

797 is like the bible. There is a lot of interpretation and a lot of things aren't spelled out. But damn it if people with their own little congregation/fiefdoms don't claim they know what their government/sky deity is thinking.

 

[Carboxide]

You can't bring anything there that isn't sterile. IV labels cannot be sterilized. Pens are fine if you wipe em down with alcohol first.

The key is very simple: Is it sterile? Then it's ok. Is it not sterile? Then not okay.

 

[npage148]

Why can't you sterlize a label? You can't sterlize the outer wrap of alcohol swabs yet they are ok. What about the outer packaging of syringes? Or even vials and bags?

 

[Sparda29]

They actually fire people here for not following the 797 procedure. Anyone else deal with this? The IV room isn't even a real 797 room, they just like practicing as if it is.

 

[Transformer]

Can someone tell me what is actually allowed into the IV hood with you? I've been told I can't bring pens in there, or IV labels for the products, or the IV log.

When I'm drawing up a dose, I usually draw up a little extra and then dump the extra onto the IV hood work area since they don't allow graduated cylinders in there either. Of course I wipe it down with alcohol, but apparently even cleaning it out with regular alcohol isn't allowed. Since when can you ONLY use those sterile alcohol wipes.

What you heard is correct.

You can bring your pen and IV labels into the clean room but not into the IV hood.

For the disposal of extra volume or overfill from iv bags, your hospital can consider purchasing stainless steel beakers that are allowed in the IV hood.

 

[Carboxide]

Why can't you sterlize a label? You can't sterlize the outer wrap of alcohol swabs yet they are ok. What about the outer packaging of syringes? Or even vials and bags?

I wipe those things down completely with alcohol...

 

[owlegrad]

Why would you want a label inside a hood? You should keep the inside of the hood as clean as possible, right? A label is not needed in the hood and is just a source of contaminates. At least, that is how I learned it. I think. Been awhile since I was working inside a hood.

 

[El Trombopag]

Since when can you ONLY use those sterile alcohol wipes.

We're wrestling with this as well. Our IV room isn't even positively pressurized, which FLOORED me when I first started. It passes the particle count tests, so we haven't been shut down yet. As the 797 standards evolve and are clarified, we may end up having to re-pipe the entire room [which facilities is adamantly against]. In the meantime, our approach is to address all the 'low hanging fruit', which includes sterile IPA. This makes no sense to me, but it is spelled out in the newest 797. I think the makers of these products had a word in the new guidelines, as we're now forking out big bucks for sterile IPA and, 'logically' sterile spray bottles. If you are going to play the 'sterile game' you will have to rotate out those plastic bottles regularly and replace with new [expensive] sterilized ones. It irks me because you're buying very little other than another little box to check off when the quality assurance commission stops by. We've always used individual sterile, lint free IPA wipes on vials in the hood, but want to look good by having only 'sterile IPA' in the IV room to spray down all items that are moved from the ante area to the buffer. What a waste.

If you don't have access to the PDF of the new guidelines, it's worth going to the USP website. There is a forum with responses to questions from interested parties. Again, expect these guidelines/recommendations to evolve, and how your state commission/board interprets them will be the true metric by which your compounding area will be judged.

Thanks again to New England Compounding for blessing us with all this crap!

 

[Sparda29]

Why would you want a label inside a hood? You should keep the inside of the hood as clean as possible, right? A label is not needed in the hood and is just a source of contaminates. At least, that is how I learned it. I think. Been awhile since I was working inside a hood.

When you're compounding 10-15 products and you have all of them in the hood at the same time, you'll need those labels to make sure the right product is going into the right bag. I'm not gonna move back and forth every time I have to make a new product.

 

[KidPharmD]

When you're compounding 10-15 products and you have all of them in the hood at the same time, you'll need those labels to make sure the right product is going into the right bag. I'm not gonna move back and forth every time I have to make a new product.

I am going to go with.... you probably shouldn't have all the materials/drugs for 10-15 different products in the hood all at once. Labels or not, that sounds like extra risk for error without extra benefit. Does your clean room not have a work surface nearby?

 

[Sparda29]

I am going to go with.... you probably shouldn't have all the materials/drugs for 10-15 different products in the hood all at once. Labels or not, that sounds like extra risk for error without extra benefit. Does your clean room not have a work surface nearby?

They do, but the area is really cramped.

 

[sakigt]

We use sterile alcohol, leave pens in the room (not in the hood) and bring in labels to double check how much youre putting in etc. Even the crazy perfect 797 place I rotated through brought labels in.

 

[Sparda29]

IMO, as long as you have good technique, the surrounding area you're in doesn't matter. I'd be perfectly comfortable and confident that an IV I made in a garbage disposal room would not grow anything.

 

[owlegrad]

Yes just keep everything in the hood, that sounds like a good idea.

 

[Rockinacoustic]

When you're compounding 10-15 products and you have all of them in the hood at the same time, you'll need those labels to make sure the right product is going into the right bag. I'm not gonna move back and forth every time I have to make a new product.

This sounds like an ISMP article in the waiting

 

[nguyenulm]

I've eaten a cheeseburger under the iv hood once. Yum !

 

[npage148]

I wipe those things down completely with alcohol...

You wipe down the paper wrap of syringes and entitle 1 liter bags?