Crowley to industry: It’s your decision but make one soon

On the one hand, the FDA faces pressure from reform-minded politicians seeking to make the healthcare industry more accessible, efficient and safe for consumers. But other than calling for product data standards the federal agency is unable and unwilling to endorse any single or even multiple brands or companies touting standards systems.

At the same time, healthcare providers and suppliers historically have dragged their feet in adopting and implementing any standards until the FDA tells them specifically what to do, and until all, if not most, players in the industry universally jump on the bandwagon.

Among the alphabet soup of standards acronyms that have appeared in the last two decades, the FDA’s Unique Device Identification (UDI) system arguably has progressed the farthest on its way to acceptance and passage as a track-and-trace solution that will work with any industry-anointed single standard or multiple sets of standards.

Healthcare Purchasing News Senior Editor Rick Dana Barlow reached out to Jay Crowley, the FDA’s senior advisor for patient safety and the government’s chief point man on healthcare product data standards, to obtain some clarity on the agency’s position amid any foggy misrepresentations wafting through industry player conversations. Crowley took time out of his busy policy-making and travel schedule to field some pointed questions.

1. It allows us to incorporate other standards, such as ISBT128 for tissues – some of which are devices – that neither GS1 [Healthcare US] or [Health Industry Business Communications Council] adequately cover.

2. It leaves open the possibility that other sector-specific standards may be developed.

3. That someone might develop a better mousetrap. At the same time, it does allow us to incorporate the two standards that are currently widely used in the industry. 

I would argue, as [HIBCC’s] Bob Hankin does, that to a very large extent, GS1 and HIBCC were designed/intended to be used together, and as such don’t really represent multiple standards as much as they represent slightly different ways of presenting the same data – and this doesn’t even include ISBT128. 

Though I understand the argument on some level, I think way too much has been made of the notion of single vs. multiple standards. There are plenty of examples of industries using multiple standards simultaneously – without any ill effect. As long as the standards/rules are clear – it really doesn’t matter. Record players did it (33, 45 vs. 78), so do banks (credit cards), computers do it all the time (audio/video/image/document file formats), state vehicle license plates, electrical power distribution in different countries, television broadcast (in 480, 720, or 1080 lines of resolution, and in a 16-by-9 or other aspect ratio), and even wireless standards (IEEE-developed the 802.11 family of wireless standards.) Editor’s Note: Crowley then quoted this information: "… the Wi-Fi and Bluetooth protocols were once commonly believed to be in direct competition with, and mutually exclusive of, one another. In time, however, Wi-Fi and Bluetooth were properly understood as largely targeting different market segments — the former, with greater range, best served home and office networking needs; the latter, with much more limited range, became the better choice for hand-held devices and other small consumer electronics. Still other overlapping standards are those adopted by the Infrared Data Association (IrDA), whose standards are for the short range exchange of data over infrared light, for uses such as personal area networks (PANs)…").  All of these coexist in their environments without any real problems.

The real issue is adoption of (international, accredited) standards and not making stuff up on your own – rolling your own, which is the real problem facing the medical device supply chain now.

FDA’s current authority only applies to device manufacturers (suppliers), so I can’t speak to the provider side. I think it is reasonable to assume that we will have to identify some standard(s) in the proposed regulation.

If by brand/company you mean, for example, GS1 or HIBCC – then, yes, as I mentioned [earlier], the real issue is to use a recognized standard and use it correctly. And for everyone downstream of the device manufacturer to know what to expect.

As I mentioned, it can’t be a complete open-loop system. We need to agree and choose some – limited – set of standards so we’re all singing from the same song sheet. If we do that it will definitely facilitate improvements in the industry. Again, as long as everyone knows the rules multiple formats will not be a problem.

Again, we don’t have any regulatory control over solution providers (e.g., materials management information systems vendors). Their drivers will be the stakeholders (e.g., hospitals, distributors), who need to document and track the UDI for various other regulatory (track/trace/recall management, AE reporting, registries, etc) and reimbursement (e.g., documentation in electronic health records) reasons.

I see UDI implementation as a convergence of many issues – supply chain savings, EHR adoption, track/trace, anti-counterfeiting, comparative effectiveness, device registries, reimbursement – and therefore by extension will be implemented on multiple levels by these many drivers. It seems to me that the many stakeholders who will drive these processes are ready and willing to act once UDI reaches critical mass. If for some reason that does not happen, then I’m sure we will act to drive implementation and adoption.