The Healthcare Hub

Anyone for a game of connect the dots? WSJ, FDA and ONC

Tuesday, February 25, 2014

Folks may not know see the linkages clearly yet, but the supply chain connection to cost, quality and outcomes is all around….at the HIMSS 14 Conference in Orlando, within the halls of the FDA and the Office of the National Coordinator for Health IT (ONC), even in the Wall Street Journal

It’s all about connecting data, systems, processes, and the various players to lower costs, improve quality and optimize reimbursements. The question is, can we get folks to connect the dots to see the bigger picture?

Let's start with the Wall Street Journal. Yesterday, the venerable paper published an article on the “anything but high tech” implantable device supply chain and the problems associated with highly manual documentation of products that are implanted in patient’s during cardiovascular, orthopedic and other surgical procedures. As the story describes: “in many cases, operating-room nurses peel bar-code stickers from empty product boxes during surgeries, paste the stickers onto a clipboard and later type the information into an order form that wends its way through the hospital's administrative channels.”

This is one process GHX hopes to solve, as the article states, with “software [that] lets operating-room nurses or other hospital personnel electronically scan the bar codes of surgical implants to generate a purchase order and invoice automatically.” The GHX system is also designed to capture product consumption and disposition data and share it with other critical systems, including clinical and financial systems. So, while the initial focus might be supply chain, the benefits of automating the data capture and related processes are much greater.

And that’s where the federal government - namely the FDA and the ONC - comes in. Last September, the FDA published the UDI rule, requiring manufacturers to label their products (starting with implantable devices) with unique device identifiers (UDIs) that are both human and machine readable. And just this past week, the ONC published the notice of proposed rule making related to the 2015 Edition EHR Certification Criterion; Interoperability Updates and Regulatory Improvements, It includes 5 pages of language (starting on page 55) proposing that “EHR technology…be able to record and display a unique device identifier (UDI) and other information about a patient’s implantable devices.”

The goal of the FDA and the ONC is better patient safety and a more connected healthcare IT infrastructure, respectively, while the GHX effort is focused primarily on the supply chain, but all three efforts are not only complimentary, but also inter-dependent. First, you need a barcode or other auto id carrier to scan, then you need technology to scan it, and finally you need systems and integration to hold and share the data.

Yesterday morning at HIMSS, I had the opportunity to ask ONC’s senior leadership to consider how to leverage supply chain to help achieve our mutual goals. While I was dutifully reminded to comment on the 2015 EHR certification criteria by April 28, I was pleased to hear ONC’s chief science officer, Doug Fridsma, MD, publicly recognize the importance of the involvement of the entire supply chain, including manufacturers as well as the healthcare delivery organizations that buy and use the products.

While healthcare is often criticized (and unfortunately rightfully so) for having a siloed mentality – clinicians work on patients, finance folks on balance sheets, and supply chain folks on products – healthcare, as well as the supply chain, are both systems. And if we are going to change the system, for the better, we need to connect the dots. The big picture, after all is better care for all.

And now I am off to the HIMSS show, for this morning’s meeting of the HIMSS Supply Chain Special Interest Group, along with members of AHRMM and the FDA to start drawing the bigger picture. We are exploring all of the uses of UDI in the healthcare delivery environment, and we want to hear from you. If you are up early and in Orlando like me, join us in Room 209B at the Orlando Convention Center at 7 am. If not, send me an email at or simply comment on this post.  

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Karen Conway

Vice President, Healthcare Value