The ORIGINAL BAXA FAQs\\\\\\\\\\\\\\\\\\\\\\\\
ValiMed™ Medication Validation System FAQs
How long has the ValiMed Technology been in use?
The first ValiMed System user, Dallas Children's Hospital, went live in October 2004.
What technology does the ValiMed System use?
The ValiMed System uses UV fluorescence to create a unique signature for each medication.
Do all medications fluoresce when exposed to UV light?
No. For new medications that are not in the ValiMed Library, drug samples need to be sent to the ValiMed Lab in Tucson to determine if they fluoresce. Our experience is that most medications do fluoresce. The lab testing determines the appropriate conditions under which to create the authentic signature.
How long has UV fluorescence been used?
More than 30 years.
How is the ValiMed Technology used in the pharmacy?
The validation is used as part of the QC process on drug preparations. The testing is always destructive, and no part of the ValiMed System comes in direct contact with the dose to be administered. The ValiMed Testing is one part of a comprehensive quality control process in the healthcare facility, and as such it should complement other methods of verification.
What does the ValiMed Technology validate?
The testing confirms a known drug sample and its concentration. The validation is a pass/fail process to confirm compounding accuracy.
What applications is this validation used for?
The ValiMed System provides medication safety for:
End product testing of high-impact medications (chemotherapy, insulin, antibiotics) and batch preparations
Validation of narcotic returns
Detection of counterfeit drugs
How long does it take to verify a medication?
Thirty to 60 Seconds, depending on the medication.
Why does the verification time differ by medication?
The strength of the fluorescent signal determines the required test time (drugs with weaker signals require a longer test time, stronger signal requires a shorter test time).
Can the device validate a drug directly in its container?
No, the ValiMed System requires that a sample of the test drug be removed from its container and placed in a disposable cuvette for validation. The test is destructive.
How much solution is required for a test?
Currently, the ValiMed Cuvettes requires a one mL sample to perform the validation.
How big is the ValiMed System?
The unit is 21 inches wide by 9 inches high and 10 inches deep. The device is deployed with a keyboard and mouse but these are not required for day-to-day operation.
Do I need to operate the system in a hood?
No. The drug sample will not be used for patient delivery so it does not need to remain sterile.
Does the device store test results?
Yes, a record is stored for each test that is performed. This data can be retrieved via reports and is used also by the ValiMed Lab for further product development.
What is the ValiMed System signature ‘library?’
This is the list of drug ‘signatures’ that have been created for users. As November 2005, there are 86 signatures.
What is a signature?
A signature is the comparative file that the ValiMed System uses to validate the medication sample. The signature represents a specific medication, concentration and diluent combination. For example, Vancomycin 10 mg/mL in D5W and 10 mg/mL in normal saline would be two separate signatures. Vancomycin 5 mg/mL D5W and Vancomycin 10 mg D5W would be two signatures.
How is a new signature created?
The facility sends its medication samples to the ValiMed Lab in Tucson, AZ. The lab team tests the sample with different UV light wavelengths to determine the unique signature.
How long does it take to create a new signature?
About a week. Customers are asked to provide the drug sample for creation of the signature.
Do you have a signature for TPN's?
No. Because the ValiMed Systems fluoresces the entire compounded sample, there are too many variables with an unlimited number of drug type, strength and diluent combinations to create TPN signatures.
How many signatures can be on the device?
There is no limit to the number of signatures that can be loaded. Currently users have an average of 20 signatures loaded. University of Michigan is using 32 signatures and estimates they could have up to 70. Some users have found that workflow is optimized by dedicating individual ValiMed Units to specific functions (i.e., narcotic validation or high-impact drug testing) rather than loading all necessary signatures onto a single device.
How many signatures are in the contract?
The standard contract includes up to 30 signatures. Users may purchase additional signatures from Baxa if the need arises after implementation.
How long is the implementation?
We are currently averaging 90 days from contract signing to go-live.
What is comprised in the installation?
Our implementation pharmacist works with your facility team to review the work flow and medications to be verified. Medications samples are sent to the ValiMed Lab in Tucson for creation of any new signatures. The requested signatures are then loaded onto the system and we set up the installation date and expectations.
How is system support handled?
Technical Support is available by phone during normal business hours. The ValiMed Units have limited warranty coverage for the duration of the lease period.
How many hospitals have the ValiMed System?
Seven, with five live users as of November 2005.
Who are current users?
Dallas Children's Medical Center in Dallas, TX; UC-Davis Medical Center in Sacramento, CA; University of Utah Health System in Salt Lake City, UT; University of Michigan’s Mott Children’s Hospital in Ann Arbor, MI; Loyola University Medical Center in Chicago, IL; Maricopa Medical Center in Phoenix, AZ, and University of Maryland in Baltimore, MD.
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