FDA to Regulate Some Device Connectivity to EMRs
I thought I was done posting for today, until I came across this. The FDA is working on a proposed rule to regulate medical device data that is acquired and stored directly into the EMR’s database.
“As the ability for direct capture evolves, the current direction FDA is heading is the medical record becomes part of the device,” he [Tim Stitely, the FDA’s chief information officer] said after a panel discussion on health information technology at the 27th annual Management of Change conference, sponsored by the Industry Advisory Council and the American Council for Technology. “I don’t think now [EHRs] as defined will be regulated by the FDA. It is not a medical device, food, drug or other thing we regulate.”
Many connectivity features support two predominate use models and can be configured to send acquired data directly to the database or to embargo data until it is reviewed and verified by a clinician. It is not surprising that the FDA would take an interest in systems where device data goes directly into an application that is used to manage patient care. In diagnostic imaging, imaging modalities interoperate with PACS for making patient diagnoses – and PACS are regulated medical devices. While EMRs are not used to make a diagnosis like a PACS, they do manage data from which diagnosis and treatment decisions are made. We may yet see a day when EMRs care delivery applications are regulated as medical devices.
There are many use cases where device data is electronically acquired and held until it is reviewed by a clinician, after which it becomes part of the patient record. This review step exists for two reasons, 1) data from the physiological parameter is unreliable (and the frequency of acquisition does not allow averaging to filter out bad readings), and 2) it serves as a security blanket for the user who doesn’t trust computers. One of the problems with this approach is that it makes all medical device data retrospective. For real automation at the point of care – and all the patient safety improvements this implies – medical device data must be near real time, and not something that occurred an hour ago or requires the physical presence of the caregiver.
Don’t expect EMR vendors to rush out to get pre market approval for their products (although it will probably come to this at some point in the future). And this certainly raises questions for folks like AllScripts and their Universal Application Integrator on the software side compared with say the Welch Allyn their connectivity SDK (which has a 510(k)). Medical device vendors will carry most of this new regulatory load, as will some specialized connectivity vendors. Expect to see some vendors turn off their “direct to database” feature and stick with clinician reviewed/batch connectivity, regardless of market requirements, because “we don’t do 510(k)s.”
If you need help, let me know.
UPDATE: Reader JM suggests that at least some FDA regulations should be applied to EMRs. I would agree that HIT vendors should at least be required to comply with the FDA’s Quality System regulation for clinical applications used in managing, treating or diagnosing patients. Requiring pre market approval may be a bit much for many types of applications.
In reading this comment, something else struck me: the “enginification” of HIT applications (noted first in the last paragraph of this post). There is a new and growing risk in the configuration of HIT applications, above and beyond the design of those systems. This recalls the patient safety controversy of a couple years ago with poorly configured CPOE systems that resulted in patient injury. (See this and this.)
The risks inherent in some application configuration also extends to hospital networks. As unregulated enterprise networks carry an increasing amount of life-critical data, the proper design, configuration, management, and monitoring of the network – both wired and wireless – is critical to realizing the full effectiveness and safety of the regulated medical devices that are connected to them. The level of network documentation that I’ve seen in some hospitals is sometimes no more than a PowerPoint diagram.
Update on CMS’ 13 Hospital Acquired Conditions
I’ve been surprised that the vendor trade press hasn’t had more on the recent move by CMS to stop reimbursing hospitals for 13 specific hospital-acquired conditions, aka, adverse events. This will have a profound impact on hospital buying decisions in the coming years. Of course the changes will be slow – this is health care, after all.
For those of you that missed the original post, you can find it here. And here is a link to a Google search that should bring up all the Internet content on this topic. The news has been picked up, and here are some interesting links.
- The trade group America’s Health Insurance Plans’ (AHIP) consumer facing web site, HealthDecisions.org has a story with lots of great statistics and cost numbers. I doubt payors will lag far behind CMS in denying reimbursement for a growing number of preventable adverse events (which, of course is most adverse events;
- Ingenix’s SDRG Report blog (yes, a health care IT vendor blog!) mentions the 13 conditions in this blog post;
- Accounting and advisory firm BKD has a mention on page two (pdf) in a recent newsletter;
- The American Nurses Association has a bit on the infamous 13;
- And, HealtLeaders Media includes a mention of the 13 in an update on the proposed CMS changes for 2008.
Finally, the Association for Professionals in Infection Control and Epidemiology (APIC) has published a great white paper (pdf) on the costs of hospital-acquired infections. (They have an interesting listserv too.) The paper shows that even with reimbursement, hospitals lose money on hospital-acquired infections. As payors end reimbursement for preventable adverse events, costs will increase – keep that in mind as you see “average reimbursement” in the white paper.
UPDATE: The ECRI Institute published a brief paper on this topic in November of 2007 (6 months after you read about it on this site).
Patient Safety Culture Survey – Take It
Associate Geoff Teed of P3 pointed me to this patient safety assessment survey the other day. Very interesting.
Patient Safety Transparency Pressures Continue
Two recent stories in Modern Healthcare highlight the continued pressure providers face on patient safety and outcomes. The Hospital Quality Alliance will be publishing hospital mortality rates later this month on this Health & Human Services web site. From the story:
then known, first released death rates for hospitals based on data from
1984. At the time, the media referred to the information simply as “the
death list,” and many hospital executives contended the raw data could
mislead patients. This time around, federal officials and healthcare
quality experts are hoping the refined mortality data release will be
better received than previous efforts.
This month the CMS will post 30-day, post-admission mortality rates for
heart attack and heart failure of patients for more than 4,000
hospitals that are Medicare fee-for-service beneficiaries. Nancy
Foster, vice president for quality and patient safety at the American
Hospital Association, a member of the Hospital Quality Alliance, said
unlike most information on the Hospital Compare site, the data are
strictly for Medicare payments. The CMS said only Medicare—using its
claims database that reflects care to the Medicare fee-for-service
population—has sufficient national data to meaningfully assess outcomes
for patients who suffer from acute myocardial infarctions and heart
failure.
Also in Modern Healthcare is this story on AHRQ's publication of sample quality report cards.
The federally funded Agency for Healthcare Research and Quality has released a Health Care Report Card Compendium,
a new Web-based directory of more than 200 sample approaches to
preparing quality report cards for use by hospitals, health plans,
medical groups, solo physician practices and nursing homes.
“The demand for information about healthcare quality is rising rapidly,
and it will be increasingly important for this information to be
presented clearly and effectively,” AHRQ Director Carolyn Clancy said
in a news statement. “Report card developers can use the examples from
the Health Care Report Card Compendium to explore the scope and
information they might want to cover, as well as various approaches to
presenting their own organization's comparative data.”
You can visit the compendium page here. While everyone in health care is in it to save lives, the industry as a whole embodies certain character flaws that cause us to resist change – even when it's the right thing to do. But between withholding reimbursement for preventable adverse event and publicly available patient safety and outcomes data, those that change will thrive and those that don't will fail – and rightfully so.
Bed Sore Treatment Device Gains Momentum
Israeli company Life Wave appears to be gaining momentum in the market with their medical device for treating bed sores (pictured right). According to Globes online, the company has signed two new European distributors. Bed sores are one of the 13 preventable hospital-acquired conditions that for which CMS will stop paying hospitals to treat in 2008 (more here).
Each distributor will have exclusive marketing rights in their countries for LifeWave’s BST and disposable electrodes.
The
company said that with these two new deals, it now has exclusive
marketing agreements with five distributors in five European countries.
Since hospitals will be on the hook for any costs related to treating preventable bed sores, any device that proves cost effective in treating bed sores should do quite well in the U.S.
At right is the Life Wave device and disposable electrodes.
