Regarding other labeling software

[siteMHX]

Hi all,

Does anyone know if any software can be used to create and print labels?

If I can create and print a label using Ms Word that conforms to the ISBT rules, are there restrictions for using that software either by the FDA or ICCBBA?

[Richard Kriozere]

All the blood bank software vendors have interfaced their products with Digi-Trax, Hema Trax on-demand ISBT128 label print system. Hema Trax also come as a stand-alone PC system for those not ready to interface. Hema Trax prints ALL ISBT128 labels in compliance with the Standard. If you tell me your LIS system we can assist...look at www.digi-trax.com under software.

[siteMHX]

We are a Misys user and they told us about interfacing with DigiTrax but I was curious if an in-house solution was developed could be it used before we looked at purchasing a product.

To jump into it more, I developed a web based program that is capable of printing 4x4 ISBT labels but before I deploy the product I was just wondering will the FDA require it be approved by them? Do I have to be a licensed vendor with ICCBBA to use it?

[Franklyn]

You may be able to get away with just a robust validation if you are not generating any custom ISBT labels.

The DigiTrax add-on will bring ISBT compliance sooner, but Misys has promised full implementation with v6.4 due out sometime next year. We are applying for a variance with the AABB because of the lack of native support by Misys. Bringing in a third party vendor (DigiTrax) is not optimal (in our opinion).

[Mabel Adams]

Since Dan provided us with that great codabar font for use in Word, I have been wondering too if there would be an equivalent for ISBT. I suspect that the licensing of the data structure forbids it. I guess I would ask ICCBBA.

Compu-type makes a scan-one/ print one printer that is cheaper than a full-fledged printer. They also advertise smaller quantities of product labels more customized than some of the other pre-printed label sources. I am waiting for an answer to my email asking them if this service will be ready for ISBT, because the website only shows codabar labels.

[heathervaught]

Since ISBT is "in the private domain", then I expect that the answer is no, since that would be a copyright infringement (unless ICCBBA was paid for it).

[Lcsmrz]

If you designed your own ISBT-128 label software, I can foresee some major validation and compliance issues, in addition to the legal problem with ICCBBA. Think of the FDA site listing some of the ISBT labeling rejects: wrong font, wrong point size, period in the wrong place, wrong wording, name placed slightly off, etc, etc, etc.

Then, there's validation, which I would considered "in-house" software development, subject to the larger documentation requirements.

Finally, if you have staffing that allows the time commitment to this big of a project, I want to come work for you ...