Sheryl Kochman

There have been reports that some weak ABO incompatibilites are not detected in low ionic atrength test systems. The gel test system is a low ionic strength test system and can miss some very weak ABO incompatibilities. That is the reason that in the US, the IS crossmatch is supposed to be done in test tubes and NOT in the gel system.

You need to keep your package inserts for as long as you keep your records of tests that you conducted with the associated product. See 21 CFR 606.160 for US FDA requirements.

You don't have to rely on "word of mouth" when it comes to Blood Establishment Computer Software (BECS) that has been cleared by FDA. There's a website you can check: http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/ucm134987.htm I do not see EPIC listed.

The list of cleared BECS (Blood Establishment Computer Software), including those for transfusion safety management can be found on FDA's website at: http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/ucm134987.htm

FMH kits are NOT subject to lot release by FDA and therefore FDA does not approve each lot. So you should not assume that "it is fine". You need to file a complaint(s) with the manufacturer or distirbutor if what you are getting is not meeting the performance characteristics and claims.

Many people don't realize that software can be a Medical Device. In this case, software used in relation to blood collection and transfusion is definitely a medical device, specifically Blood Establishment Computer Software (BECS) and anyone developing it is considered to be a medical device manufacturer who is required to comply with the requirements in Title 21 CFR 800. That means you must register with FDA, list your product with FDA, follow the Quality System Regulation (which includes providing customer support for the life of the device), file adverse event reports, and much more. In the case of an "antibody registry" it is likely to include patient identifiers and other patient related info. So it is probably also a Medical Device, specifically a Medical Device Database System (MDDS). Anyone considering development of such software needs to learn what is required by the US FDA before you get too far into the process. Check out the website at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm

Have you run a control of normal serum or even 6% albumin? I have seen frozen cells that will react with anything that has protein in it and suspect it is related to a change in cell surface charge causing non-specific binding of protein.