Pedigree Laws and Bar Codes
Other industries look at the life cycle of a part as being from cradle to grave. However, liability must be extended even further in healthcare because we must consider a mother’s prenatal health and even the future health of a deceased patient’s progeny. Consequently, for the planning of new systems, we must consider a more-inclusive “womb-to-tomb” philosophy.
Looking toward the future, a working example of this can be found with the system enabled in the United Kingdom by what is now called MRHA (Medicines and Healthcare products Regulatory Agency.)
A rigorous tracking system was put in place to restore consumer confidence in British beef after the reporting of bovine spongiform encephalopathy (BSE), commonly known as mad cow disease, throughout the British beef supply. When consumers became concerned about the pedigree of their steaks and hamburgers, they simply quit buying them.
To ensure the pedigree of the beef at supermarkets, farmers are required to track each animal with a unique number and log the pedigree of all the food and medication the cow receives over its lifetime. The meat package a consumer buys in the supermarket must be traceable to a farmer. (Some farmers say that, quite frankly, the health of cows in the United Kingdom is now tracked more efficiently and thoroughly than your granny’s health in her nursing home.)
Most of this tracking is facilitated with bar codes. The animal itself receives a tag that contains an identification number, a bar code encoded with the same number, and in some cases even an RFID-enabled device. Food and medication typically come with bar codes, so all inputs can be collected with minimum effort. When the animal goes to the slaughterhouse, the bar code ID is cleared and the data are linked to packaged meat. Finally, the packages are cleared by the supermarket receiving/dispatch points to ensure a BSE-free pedigree for each consumer.
In the United States, pharmaceutical and medical device manufacturers are being challenged with pedigree regulations from states such as Florida and California and with requests from major distributors driven by hospitals and insurance organizations. Bar codes represent a very cost-effective way to facilitate data capture and eventually may be an absolute imperative for distribution systems that are not equipped with an RFID infrastructure.
Currently, healthcare pedigree regulations require traceability back to a supplier and a purchase order. The pedigree of goods is a labeling issue and involves single-company integration of data.
Sophisticated companies can trace goods made in-house through batch records and part numbers amalgamated with lot numbers and expiration dates. Currently, bar codes, which in the future may also be augmented by RFID, are the fast method of transferring ID information on a physical basis to the next company and/or node of the supply chain. (Freight handlers use bar codes to trace each of their transaction points and ensure appropriate priorities for special shipments such as cold-chain packages.)
These current healthcare pedigree practices preclude counterfeit-enabling practices but do not yet ensure that the product is genuine at a consumer level. In other words, pedigree laws seem to be establishing historical traceability and liability chains. However, from a consumer’s point of view, the user is still reliant on the goodness of the pharmacist and supply chain because the user cannot establish authenticity. He or she can only respond after a bad result.
In the near future, unique bar codes for each product will allow for traceability from “womb to tomb” and will be a critical part of compliance with whatever pedigree requirements are imposed.