Is there a need to better track the use of medical devices? You bet. Besides tracking implantables for post market surveillance and recalls, tracking medical devices used at the point of care can reduce the risk of infections like methicillin-resistant Staphylococcus aureus (MSRA) through physical contact and cross contamination. There are no national hospital reporting requirements, and few state requirements for these infections. This story in the Baltimore Sun reports on a news study released by the CDC on MSRA infections:

"This is the first time that we've been able to measure the number of infections," said the study's lead author, Dr. R. Monina Klevens, an epidemiologist with the federal Centers for Disease Control and
Prevention. "We were surprised that the rates were so high. It's a call to action."

Industry consultant Brad Sokol developed a Medical Device Pedigree for tracking the use of devices and related patient outcomes last year. You can get the low down on Sokol's pedigree from this presentation (pdf) on the FDA web site.

His theory predicted 13,000 to 26,000 thousand deaths from infection caused by contaminated medical devices and instruments. In the new study, "Of those infected with MRSA, almost 1,600 died, about 18 percent of the total. Extrapolating those figures to the entire U.S.
population, researchers said some 94,000 people might be infected, with 19,0000 deaths." It would seem that Sokol was right on target.

The paucity of quality and outcomes reporting by providers is slowly changing as hospital and physician data is published by CMS and other federal agencies, state governments, hospitals themselves, and others. But we have a long way to go.

Much of the debate about Unique Device Identification (what the industry refers to as "UDI") for medical devices is misdirected. There is too much talk about needing a unique identifier, as if the law did not already mandate one (see this, and here).

MDDI magazine ran a story that revealed the real UID agenda, From Information Silo to Bridge: The State of UDI. The real issue here is the need to track medical devices - especially implanted devices - to determine their performance. From the MDDI story:

When it comes to devices, comparisons with other products are inevitable. For example, the Advancing Patient Safety Coalition recently compared medical devices to peanut butter. Specifically, in a letter to congressional members dated June 18, 2007, the  coalition stated, "We can simply and quickly identify each and every jar of peanut butter that might have salmonella and remove them from store shelves in hours, but we cannot do that reliably today with potentially life-threatening defective medical devices." Similarly,
during a 2006 CDRH public meeting, Larry Kessler said that the medical device industry is "probably a decade or more behind the grocery industry" in terms of product tracking.

By equating medical devices with peanut butter, the authors imply it is the device vendor who is responsible for this sorry state of affairs. In fact, the guilty party is the equivalent of the grocery industry, health care providers.

There is no doubt that better tracking of medical devices would improve recalls, provide better post-market surveillance to better reveal safety issues, and reduce avoidable infections. But we don't need some new fangled UID standard affixed to medical devices to do it. Here's what's really missing:

  1. A mandate that providers track, record, and report the use of all medical devices (and associated clinical outcomes data) without exception,
  2. A repository where data is aggregated across providers, devices and device vendors, and
  3. Someone to analyze this data and report it to the public, providers, patients, and vendors for appropriate responses and follow up actions.

This makes forcing device vendors to replace the currently mandated unique identification (you've probably heard of them, serial numbers) with a "new" and "improved" UID seem like the side show that it really is. Let's assume that AdvaMed doesn't muster the political leverage to forestall the UID, and in a few years some standards body promulgates a new UID standard. Okay, the easy part is done, now for the hard stuff.

  • Who's going to mandate that providers do all this tracking and reporting?
  • Who pays for all the fancy new IT and labor required to track and report this data?
  • What entity(s) will assume responsibility for maintaining this repository of medical device usage - and outcomes?
  • Who will enforce the implementation and conformance of this reporting by providers - and what penalties will be incurred for non-compliance?
  • Who's going to manage the recall communications and follow up?
  • Who's going to assess post market surveillance data and issue recalls? (That's pretty easy, the FDA would clearly handle this - but they'll need more money.)
  • What about patient privacy, who will be responsible for maintaining it, and will patients be able to opt out?

The scope of the UID system that's required to achieve the benefits many have attributed to this "great leap forward" becomes more clear. In fact, you could implement all the tracking and gain the very same patient safety improvements using the industries current UID, vendor serial numbers.

I should also note that vendors are currently required to maintain device history records that would benefit greatly from data held by providers (patient data for implants, near miss events, outcomes data) that is currently unreported. A simple mandate requiring providers to report this data to device vendors, and an open source software project driven by a foundation or university is a more direct and efficient solution.

All this really doesn't have much to do with a fancy new identification number, does it?

Pictured right are some blood transfusion ID labels from the UK Blood Transfusion & Tissue Transplantation Services web site. The tracking of blood products might serve as a benchmark for UDI efforts.

UPDATE: From iHealthBeat, "Sen. Edward Kennedy (D-Mass.) on Thursday sent a letter to HHS Secretary Mike Leavitt urging the agency to finalize rules to implement the Patient Safety and Quality Improvement Act of 2005, Health Data Management reports."

And this from FierceHealthcare:

Over the past week or so, the mainstream news media have crackled with the news of staph infections (including MRSA) found in  community schools. Prompted by this, Rep. Tim Murphy (R-PA) has filed a bill tha would require all hospitals in the U.S. to report infection rates t HHS. Under the terms of the bill, HHS would make such information available publicly on its website.Such a measure would trump existing infection tracking underway in the states. Right now ninetee states require infection reporting, but not all make the information public. (Murphy's home state of Pennsylvania does make hospital-acquired infection reports available at www.phc4.org.)