I just returned from a meeting of the provider and manufacturer advisory boards working with GHX to create an industry solution to the challenges faced in managing implantable devices. You know, I love it when a plan, or more importantly, an industry comes together. The combined advisory board, which includes some of the most well-known and respected organizations in the worlds of cardiology and orthopedics, are tackling this problem from all sides: clinical, operational and financial. Working with organizations like this – and seeing how they are working with one another and aligning internal functions - gives me hope that we truly can transform healthcare in a meaningful way.
Working with the FDA, other government agencies, clinicians, academic researchers and others on unique device identification (UDI) in healthcare, it’s become increasingly clear to me that we can minimize costs and accelerate our objectives, if we coordinate our efforts.
Here’s an example: I was pleased to discover that the very same manufacturers working with GHX on its implantable device supply chain initiative are also involved with various initiatives underway to leverage UDI for postmarket clinical research.
For example, orthopedic manufacturers are helping Weill Cornell Medical College and Kaiser Permanente make sure they are correctly capturing the right attributes about products that will be held in the International Consortium of Orthopedic Registries. That network of registries, which will eventually hold data on more than 3.5 million orthopedic surgical procedures and all the implantable devices on the market, will help researchers (as well as manufacturers) better understand the impact various attributes have on performance.
Manufacturers are also supporting work being done by Harvard Medical School to track cardiovascular products from purchase through consumption and utilize electronic health records (EHRs) and clinical registries to assess their safety and effectiveness after they have been marketed. Mercy’s lead for the project, Joseph Drozda, Jr., M.D., FACC, believes the effort can also help suppliers meet the increasing demands being placed on them for postmarket research. The FDA’s Jay Crowley, meanwhile, stated at this week’s UDI Conference that more robust postmarket data on the use of products in the treatment of specific patient populations could facilitate pre-market clearance.
Dr. Drozda also recognizes the important role the supply chain and IT play in this largely clinical effort. After all, if you don’t accurately capture data on products being used in patient care at the point of use, you have nothing to use for those studies. Mercy and others involved in the GHX implantable device supply chain advisory board and in the postmarket research initiatives are creating the critical linkages healthcare needs to get to value as quickly and effectively as possible, without duplicating efforts (and costs) that often occurs when work such as this is performed in silos.
Earlier this summer, we announced the results of some of the pilot work being done by members of the implantable device supply chain initiative to create the perfect physician preference item (PPI) order, which is far more complex than the typical EDI order due to the need to include more information such as lot and serial number. The work of the participating providers and suppliers has also yielded a list of best practices and focus areas for those seeking to optimize both processes and data around implantable devices:
GHX is proud to be supporting these efforts. Yes, we are building technology solutions that can be used by suppliers and hospitals alike. We are also, as one of the suppliers pointed out yesterday, creating a common ground where the various parties can explore opportunities to create change healthcare, for good.