My introduction to barcodes in diagnostics was memorable. Twice.
In the first instance, we tested a batch of sheets of 100 barcoded labels for a pharmaceutical customer. They all passed, and we shipped them back. A few weeks later, the customer called to report they were failing. At the on-site meeting after a sleepless night, we discovered that the customer had affixed the labels to a reagent cartridge for their automated lab analyzer, where the barcodes were failing. The customer had forgotten that the label alignment on the cartridge changed when they replaced the analyzer. The barcodes were, in fact, fine. Whew.
Diagnostics, Point-of-Care and Blood
It was an important insight into the important role those barcodes play in diagnostics, identifying not just the patient, but also the reagent type, lot number, expiration date, and other critical data. If the barcode doesn’t scan, the diagnostics fail, and the time-sensitive treatment sequence is halted. Serious stuff.
Recognizing this, the FDA UDI rule requires that diagnostic devices must also carry compliant barcodes—not just the consumables.
Barcodes are everywhere at the point of care:
- Glucose meters
- Rapid strep and COVID tests
- Blood sample tubes
- Urine and other samples
Barcodes are also used on blood bags—these are among the most carefully controlled in healthcare. Blood bag barcodes identify the blood type. A mismatch with the patient can cause death, so the barcode on the patient’s wristband is also extremely important.
The second instance…
Ten years ago, I had a personal encounter with barcodes in medical diagnostics. It’s fair to say the barcode saved my life. I was experiencing some mysterious weight loss and difficulty eating. A visit to the ER and an emergency endoscopy found Stage 4 esophageal cancer. Radiation dispatched the tumor that was restricting my stomach, but the cancer had metastasized all over my body and into my brain, and I couldn’t tolerate the chemo. I had six months to live.
I stumbled upon a clinical trial for Pembrolizumab—that’s another story in itself. If I had a large enough tissue sample and if we could get it to Scotland in 24 hours, I might get into the last remaining spot in the cohort. The barcode on the tissue sample identified me and diagnostic data about the sample. No doubt there were barcodes on the package in the jet to Glasgow, where I was approved for the clinical trial of what became Keytruda. I went from terminal in six months to cancer-free in six months.
The personal drama aside, laboratory specimen identification is probably the most critical application of barcodes, and perfectly suited to their strengths as a data-rich, non-volatile information carrier.
But the barcode must work right.
Contact us or schedule a fee 15-minute barcode quality consultation here.
