Needleless Flolan preparation

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[edit] Flolan Preparation Without Needles

Because we had a bad experience with using the needles in preparing Flolan, we were introduced to a method that uses no needles. Instead, it uses a device with the unwieldy name "Universal Vial Access Spike With Needleless Connector" made by Churchill Medical Systems and available through the Flolan distributor.

This system has, in our experience, a couple of advantages over needles, not the least of which is the avoidance of most dangers of getting poked by the needle. I'll point out those advantages as I outline the procedure for using them.

What follows is meant to supplement the steps on the article page (Needle based preparation techniques), in a sense, to replace the talk of affixing needles, etc. Most of the other steps --- washing hands, preparing the area, removing air bubbles from the cassette --- remain the same.

You'll need one Needleless Connector for each bottle you use. In our case, we have two 50 ml bottles of diluent and two red capped (1.5 mg) bottles of Flolan powder, so it's four (4) needleless connectors.

The Needleless Connector is shipped with each one in its own sterile package, paper on one side and clear plastic on the other.

 

 

 

 

 

 

 

I find that the easiest and most aseptic way to fix the connector to the vial is to carefully remove the paper backing from the package, hold the connector inside the plastic (without compromising its sterility), and carefully push it down onto the top of the vial, taking care to make sure that the spike in the center is as close to the center of the rubber seal as it can be. The prongs on the side of the Connector will click onto the vial's cap and hold it securely. Then you can remove the half of the package with which you were holding the Connector.

Note the collage of four images above. In the leftmost image, if you look closely, you can see the spike in the center of the plastic unit; this is what penetrates the rubber seal at the top of each vial. Next note that I first "steer" the Needleless connector by holding it toward the top, but (in the third shot) when I start to push, I slide my fingers down toward the base so I can push firmly on both sides of that base. If you don't do this, the Connector has a tendency to resist and move sideways. Finally, you'll see my hand taking away the sterile plastic wrap (sterile on the inside, which is what has been in contact with the superstructure of the Needleless Connector).

To the right is a shot of a red-cap Flolan powder vial, awaiting its opportunity to be "crowned" with its very own Needleless Connector.

Here is a "family portrait" -- all of the vials, both diluent and Flolan powder, ready to go to work.

In this next image, you'll see that I have attached a 60 ml syringe to the diluent vial. This image shows what we find to be one of the advantages of the needleless system: it is extremely easy to fill the syringe with the fluid with just one hand. Simply turn the syringe upside down and pump, squeezing air into the vial, letting go and letting the air pressure push the liquid diluent into the syringe. It usually is necessary to lift the syringe to pull the last few ml of liquid out, even to get a big air bubble into it, to swirl gently around to remove the small bubbles that form on the inside of the syringe. Then, when the air bubbles are out, gently press the syringe to move excess diluent back into the bottle, to leave yourself with exactly 50 ml. (The bottle does, in fact, despite its 50 ml labelling, contain a slight excess, and you don't want to dilute the medication ultimately in the cassette.)

Once the syringe has 50 ml of diluent in it, I go to the Flolan powder vial (in our case, we're using the 1.5 mg red cap vials; you may be using those or the .5 mg blue caps, or a combination, dependeing on your dosage).

Push some of the diluent into the Flolan vial, enough to dissolve the powder. It's here that the needleless adapter shows another of what we regard as key advantages: it is very easy to put the liquid in, swirl it around to dissolve the powder, doing so gently so as not to create bubbles, and then extract it.

In particular, when I use a needle for preparing the Flolan (as I do when we travel -- more on that later), I find getting all of the reconstituted medicine OUT of the vial to be tricky. It's necessary to gently and carefully pull the needle almost all the way out, but not quite, and then pull back on the syringe just at the right time, at the right angle, so as to get all that concentrated reconstituted liquid out. The needless adapter, I find, was designed to drain whatever vial it has been inserted into. So it's not hard to drain it.

That said, another technique I would recommend adapting, whether you use the needles or the needleless system, is to partially fill and then fully drain the Flolan powder vial two or even three times. With each successive filling and draining, whatever residual solution is left in the vial is more fully diluted; meaning, you are leaving less and less of the potent medicine behind.

The process is to fill a syringe with 50 ml of diluent; dissolve the Flolan powder in one of its vials; put it into the cassette; then repeat. Obviously, if you are using more than two Flolan vials, you would modify that to two or even three (more?) Flolan vials per 50 ml of diluent. When done, using the needleless system, you will have a "family portrait" of empty bottles, such as you see here.

And here's yet another advantage, at least from the perspective of convenience: this "family," as you see them, is thrown in the trash, along with all the waste paper, etc. No need for Sharps Container. I was disappointed (as someone who believes in recycling, to learn that the glass vials, albeit with little metal caps, aren't accepted in our local recycling program ... so we are contributing to the unfortunate landfill problem, but that's a topic for another time and place.

So what are the disadvantages of this Needleless Connector system?

1. The primary disadvantage to us is the extra volume of storage. A needle is very small. Even if you use two or three day (I was trained in a method of using just one a day) those needles still take up very little room. In contrast, for us, using four of these Needleless Connectors a day, for the 28 days of the month, that means 112 of these things; they probably take almost as much space as any other single component in the Flolan closet.

2. It happens rarely, but every once in a while, I've come on a connector that fails; it has a small crack or other defect that causes a loss of diluent or, even worse, diluent that already contains some of the Flolan. Because it usually is noticed only after spilling (and contaminating) several ml, I end up having to discard at least half, if not all, of that day's medicine. Now, I think our suppliers expect us to practice good, safe, sterile procedures, and therefore we should be starting over when something compromises the process, but if this happened frequently, it would cause me to rethink the process. As it is, it's happened maybe twice in a year (so approximately 2 connectors out of 1460 (4 x 365 = 1460); we can tolerate that.

Because of that first disadvantage, as I've already suggested, when we travel away from home, away from the luxury of having a cabinet dedicated to storing all this stuff, I use needles. It's a lot easier to pack a supply of needles for a week or two.

And the advantages, once again, of the Needleless Connector system?

1. Primary one is that it is physically less threatening, less worrisome, as there is far less likelihood of accidentally being stuck. (When I go to the Red Cross to donate blood every two months, one of their stock questions is "Have you had a hypodermic needle puncture in the last three months?" The one time I had had, they let me give anyway, because I assured them the needle was entirely sterile ... but I prefer not to have to answer "yes" anyway!!)

2. Just mechanically, the filling of the syringe with diluent and the total draining of the various vials, in particular that containing the Flolan powder, is far easier, requiring far less in the way of manual dexterity and precise handling. This enables you to concentrate on what really matters: getting the mix right and doing so in clean and aseptic fashion.

3. Disposing of everything. Granted, it does make slightly more landfill, but given the quantity of all the rest of the Flolan supplies that are disposed of each day, these don't add much, and they don't require the Sharps container.