Cold Chain ≠ Arrested Development

Netflix gave me an idea when they announced they were resurrecting one of my favorite TV shows.  As I had the pleasure of speaking at an Expeditors International seminar last week about temperature monitoring in the health care cold chain, I decided to tie the theme of my presentation to the soon to be continuing perils of the Bluth Family so well chronicled in the show “Arrested Development”.  The foundation for my presentation was that the cold chain of tomorrow is a very different one from today.  There are a number of changes that are dramatically impacting the industry including:

  • The increasing number of off-patent drugs
  • Increase in the volume and value of biologics
  • The shift to using 3PLs
  • Increasing climate instability making summer/winter packaging riskier
  • The disappearance of wide body aircraft on domestic flights limiting use of active refrigerated containers
  • ePedigree, serialization and inference
  • RFID proven safe for biologics

The impact of these changes will require healthcare manufacturers (both for biologics and even medical equipment) to rethink their cold chains. Even when routes are validated and procedures are in place, what can you do to ensure that temperature sensitive products are safe for use when delivered?  To quote a famous American president:

Trust but Verify

Yes.  Trust but verify.  It’s one thing to trust your supply chain but it’s equally critical to verify that the products have been properly handled as they move from manufacturer to the customer.  ISO Class 3 RFID provides this capability.  Because it can be read through containers without opening or unpacking (helping to document authenticity) and provides a complete temperature and way point history, Class 3 RFID tags (like XC3 Technology) make it easier to implement a solution that helps manufacturers and 3PLs to manage – not just monitor – their cold chains.

The health care and pharma cold chain should utilize new technologies to address new cold chain dynamics.  Doing so will prevent “Arrested Development” for the cold chain and, to quote one of the show’s characters, prevent you from “making a huge mistake”.

To view the presentation on SlideShare, please click here.
Kevin Payne

Senior Director of Marketing

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From NPR: Tissue Tracking and Health Risks

During my drive to the office this morning I heard an interesting story on NPR’s Morning Edition titled Little Regulation Poses Problems Tracking Tissue.  You can listen to or read the entire story here.  According to the story, each year in the United States, almost 1.5 million medical products are used  for surgeries made with tissue taken from cadavers.  Despite this vast number, fortunately there have been few issues or problems so far associated with using human tissue but, when there is an issue, it can be tricky to catch and the consequences can be life threatening.

1.5 million medical products are used each year for surgeries made with human tissue

The story describes a case where tissue contaminated with Hepatitis C was accidentally distributed for use by patients.  Hospitals had to be alerted and the race was on to find where the tissue had been sent.  The story states: In this case, 44 ligaments, tendons and other donated tissue were sent to hospitals and clinics around the country. Unlike organs, which are quickly transplanted, tissue can be saved and stored for use at a much later date. A month later [Italics are mine], the CDC found 15 people already had been implanted, but didn’t contract the disease. That’s because their tissue was scrubbed with strong chemicals. But there was one infection: A child in Boston received a heart patch, and because heart tissue can be cleaned only lightly, that child contracted Hepatitis C. The child’s current health condition hasn’t been made public.

According to the story, the FDA says it continues to evaluate the need for new regulations and has started requiring tissue banks to do limited tracking but, once the tissue is sold to hospitals, clinics and doctors, it is voluntary for those surgeons to report back what tissue gets transplanted into which patient.  And, as the business grows globally and tissue comes to the U.S. from countries around the world, keeping track of tissue is even harder.

Matthew Kuehnert, a doctor at the CDC whose job it is to protect donated blood, organs and tissue suggests the process of receiving tissue should be similar to buying cereal at the grocery store.  Said Kuehnert, “It has a bar code on it, and it can be tracked back if there is some sort of problem with it in terms of quality,” he says. “You can’t do that with tissue right now. And that is a gap.”

While I get where Dr. Kuehnert is going with his cereal analogy, I think it comes up a bit short.  Unlike cereal, tissue is temperature sensitive.  You not only need to be able to track where it has come from and where it is going but also monitor and track the condition that it’s been stored in along the way.  If tissue isn’t stored at the right temperature, it can also cause problems that can lead to health implications.  Bar codes can’t monitor for that. Fortunately, RFID temperature sensors can, while also storing the information about the tissue and help improve track and trace capabilities.  You can read about this here.

Kevin Payne

Senior Director of Marketing

Study Documents RFID Safe for Biopharmaceuticals

A study published this week in the July/August edition of the Parenteral Drug Association’s PDA Journal documents research that showed that in vitro test results for more than 100 biopharmaceutical products from eight major drug companies demonstrated no non-thermal effect by radio frequency radiation.

RFID is OK for Tracking and Monitoring Biopharmaceuticals

What does this mean?  The research conducted by researchers at The University of South Florida, Blood Center of Wisconsin, Abbott, Georgia Institute of Technology and the Madison RFID Lab at the University of Wisconsin documents that using RFID in conjunction with biologics is safe.  The thermal effects of RFID on biologics have been well understood (no impact) but there had, to this point, been limited research on the non-thermal effects (RF radiation) of RFID on product integrity.

Why is this important? Pending ePedigree laws in California (going into effect in 2015 and ultimately impacting the entire industry) are likely to require a combination of RFID and 2D barcoding systems.  Some had questioned whether or not RFID was safe to use for these types of applications but this report (available to PDA members on the PDA website) demonstrates RFID’s safety, enabling technology companies, pharmaceutical manufacturers, shippers, 3PLs and health care providers to move forward more aggressively on developing solutions for ePedigree and documenting the safe and authentic shipments of biopharmaceutical products.  But, RFID can add even more value.  Temperature sensor RFID tags, beyond providing the ability to document track and trace records for ePedigree can also be used to monitor and manage the temperature (and related safety and efficacy) of drugs as they move through the supply chain to reduce waste and improve cold chain operations.

You can learn more about Intelleflex solutions for pharmaceuticals here.

Kevin Payne

Senior Director of Marketing