Healthcare is in the business of saving lives, healing the sick, fixing the broken, curing diseases and improving the quality of life and life expectancy of our communities where we live and work. This tremendous task requires an enormous amount of personnel, medical equipment, medical supplies, medical devices, implants, pharmaceuticals and an almost immeasurable amount of non-clinical supplies and services. Healthcare also loves idiosyncrasy. Every patient is unique, every medical procedure and situation can be unique. Healthcare is also passionate about privacy, and we have many regulations in place to ensure that patient data security is maintained. This combination of uniqueness and privacy has also created an environment in healthcare that results in many operational, process and informational silos. One of the areas most impacted by these silos and disparate processes is the end-to-end medical device supply chain. A PNC Healthcare and GHX study in 2011 estimated that this disparity and lack of collaboration and transparency results in $5 billion in waste each year. In addition to the product waste, the lack of visibility and standardized process also results in clinical staff performing supply chain activity instead of patient care. A key to removing this waste from the medical device supply chain is end-to-end supply chain visibility.
In planning an implant procedure, the surgeon requests a tremendous volume of parts. For a knee replacement, the doctor may order a surgical kit with knee sizes two through six, and only use size four. Each implant comes with essentially a closet-sized tote bin of product going into a surgery. If other industries have been able to achieve value by bringing visibility to all stakeholders in their supply chain from raw materials to consumption, why can't healthcare? When dealing with a resource as precious as a human life, it is inconceivable that we can more precisely track a t-shirt from production to its purchase at a clothing store than a pacemaker, orthopedic joint, spine implant, cardiac stent or any pharmaceutical. One of the keys to solving this visibility and transparency problem in healthcare is getting every stakeholder from manufacturing to distribution to care provider to payer committing to and conforming to a common data standard. Today a medical supply may have anywhere from one to six barcodes on the package. Each with different data and in a different format. While the FDA did establish a Unique Device Identifier (UDI) requirement in 2013, the implementation and adoption has been slow and inconsistent.
The rule is only for certain classes of devices and the final requirement for all devices has been extended. With the increased use of Electronic Health/Medical Records the need for exact product identification and the knowledge of the entire history of that item from production to consumption is necessary. This visibility not only reduces inventory waste, it improves the quality of patient care as we can start to link patient outcomes to product. It also improves patient safety as product can be scanned into a procedural case and the clinical staff can receive alerts if they scan a product that is expired or has been recalled. The time is now for everyone in the healthcare industry to unite and demand commitment to interoperability and the consistent use of data standards. To break down the barriers to information sharing for medical and pharmaceutical inventories and product pedigrees. Billions of dollars of waste could mean less cures for cancer, a lower quality of life for a patient with a chronic disease, or less care is available to those that need it.