MedWatch Billboard Spotted Requesting Reports about "Shoddy" EMRs

Below is an image originally posted by Mr. HIStalk and submitted to the blog by one of his readers. It's a sign in an unknown city requesting reports of "shoddy" hospital electronic medical record systems to FDA's MedWatch. The only part of this story that gave me pause is the use of the term shoddy in the sign. This does not seem like a word that would be used by the government bureau tasked with the regulation of medical devices. To make sure that it was legitimate, I called the 800 number and did get a recorded FDA announcement. So there we have it! FDA is seeking patient or consumer reports about shoddy medical record systems.

Here is how MedWatch describes its mission on its web home page: Your FDA gateway for finding clinically important safety information and reporting serious problems with human medical products. Certainly the posting of a sign such as this appears to be well within the scope of its mission. The web site also provides a link on its home page that allows one to Report a Serious Medical Product Problem Online. Follow this link and you are presented with the following form: MedWatch Online Voluntary Reporting Form (3500).This sounds a lot more like the FDA style.

A thought occurred to me initially as I pondered this sign. How would a patient have the opportunity to recognize a malfunctioning (e.g., shoddy) medical record system, either in a hospital or physician office setting? In a hospital, most patients don't get closer than five feet from an EMR terminal and don't usually have the opportunity to browse their own records. The physician and nurses who use it on a daily basis may think their system is shoddy but usually they don't share this sentiment with patients. Then the irony struck me. Certain forward-looking health systems like Kaiser are providing their patients access to their own EMR data via a personal health record (see: Kaiser Offers Members Access to EMR Data). In so doing, could they be setting themselves up for complaints to the FDA, given the fact that an occasional error may crop up in the personal data viewed by patients?

Comments

[Federico Monzon]

Bruce:
The ad doesn't specify that it is directed to patients. Health professionals could be the target of the billboard. As you mention, healthcare workers would be more likely to know about "shoddy" EMRs but they might not know where to complain if they think the EMR could be potentially impacting patient care.