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Any bedside transfusion system must be cleared by the FDA. All cleared devices can be found at http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/ucm134987.htm The vendor should be able to give you a BK #.

We have validated them. They seemed pretty straight forward.

How about "Transfusion Talk"

Korchek Technologies has the CareChek product suite that does more than the Bridge product.

Positive identification systems that use bar-code scanning at the bedside for transfusions are considered blood bank software. Make sure that your vendor is cleared by the FDA.

Thanks for all your information. My main concern is that the software manufacturer themselves are now doing the validations and this was written into the contract with the sale of the product. Will the software makes disclose all/ any problems associated their product? Will they test it outside of the scope of what their product does? This is my main concern. Of course I think the best way is to validate it yourself but if you don't have the staffing an 'independant' consulting group would be my next choice and that would not be the company that created the product.

Please don't advertise in the forum.

Mobea- We have done hundreds of conversions of all different vendors and departments ranging from Donor, Transfusion, AP, Radiology, Laboratory... and more. We have also performed validations of Donor Doc and e Donor for several institutions. Feel free to contact us with any questions you may have. You can review our services at www.korchek.com or you can contact me directly at lori@korchek.com.

I am not sure how they present it to the end user. I would not be comfortable with the vendor telling me everything is OK, don't worry about it. Would you?

I don't think you will have much choice with web based systems. BBCS may have one. Most of the large vendors like Wyndgate, Cerner, Sunquest, Soft are client server and will probably be costly.

How does the FDA feel about vendors validating their own software? Isn't independent review a covenant of Quality Assurance? Mediware started by restricting who can validate their systems. Now Wyndgate has followed in their footsteps by offering validation through PeopleMed, another Global Med company. Don't these companies have a vested interest in how their software is tested? The blood bank does not even know this is happening because these services are buried in contracts that are signed in the "ivory tower". Blood bankers need to be involved with selection process and contract negotiation.

You must be more specific. Delphyn is not a known blood bank system in the US.

Most sites use a third party to validate their computer systems. In the long run it saves time, money, and a lot of aggravation.

We work with many Cerner clients in building their system to accomodate ISBT as well as validation of their ISBT component. There are several ways in which you can handle this. Feel free to contact us: Korchek Technologies www.korchek.com 203-452-8295

Cleansing of data can be done during the migration. We have Cerner consultants that can handle this migration and give you solutions how to cleanse it.