Comments on: EMRs should be classified as a medical device to protect patient safety

By: katrina howard

katrina howard — Mon, 30 Apr 2012 21:12:41 +0000

Given the potential for lethal harm and the number of “junk” programs, EHRs should definitely be regulated as Class III medical devices – and Human Factors engineering should be an absolute requirement of the system development. HFE would probably eliminate the “configuration error” described by Mr. Voran. Yeah, yeah, we’ve heard it a million times, …the certification process is so brutal, expensive and time consuming. Try working with some of these programs, they are hedious.

By: Russ King

Russ King — Mon, 30 Apr 2012 20:56:22 +0000

Classifying EMRs as a medical device would not be advisable for reasons stated previously.

HOWEVER, EMR products should be subject to controls and regulatory oversight to ensure that public safety is not compromised but lousy software development practices. EMRs is fast becoming safety critical as Dr. Fisher’s story clearly relates. The clear issue Dr. Fisher highlights is the need for controls ensuring public safety regardless of whether EMRs should be classified as a medical devices, or subject to 21 CFR Part 11, or UL 1998, or some additional standard designed to ensure that these kinds of software companies meet an evidentiary standard for maintaining practices which uphold public safety.

I would advice EMR companies to get together and establish their own best practices, evidentiary standards, and regulating body before the Federal Government does it for them.

By: Mark LeBay

Mark LeBay — Mon, 30 Apr 2012 14:19:54 +0000

KLAS is an organization that’s doing good work tracking customer feedback and tracking issues and rating EMR/EHR software:

Their website is here:
http://www.klasresearch.com/

I aggree with David’s points and would add that EMRs are about a hundred times more complex than any single medical device and the desire of hospitals and clinics and specialists and individual providers to customize the build of the EMR system they buy makes it impossible to define the EMR in a way that would be amenable to treating it as a medical device.

By: David Voran

David Voran — Mon, 30 Apr 2012 13:13:53 +0000

This suggestion would be disastrous. The huge additional cost and delay that would impose in getting all of the 1,000 or so EMRs certified as medical devices would eliminate all of the best, small vendors and prevent just about any EMR vendor from improving their product until those improvements were certified.
Couldn’t agree more about the junk that EMRs spit out. In the case above whoever chose to print that report selected all medications including discontinued ones and reflects a configuration error by not selecting only current and active medications.
Warfarin is tricky as the dosages are often adjusted weekly and sometimes managed by the patients. You’re going to get the same issue with insulin as the current dosage of one or more of the products prescribed are mixed and changed frequently. Having yet figured out a good way to get this out of our system either but more often than not I see people not even taking the time to document the current warfarin dosing schedule.
But back to the original pretext. Be very careful of what you ask. The medical device approach is paralyzing the mobile devices to record heart tones, ultrasounds, etc. in the sleeves that can fit over an iPhone or other smart phone. As a result they will probably be released as consumer products since the certification process is so brutal, expensive and time consuming.