FDA on Health IT Adverse Consequences: 44 Reported Injuries And 6 Deaths In Two Years, Probably Just 'Tip of Iceberg'

The Office of the National Coordinator for Health IT held a meeting of the HIT Policy Committee, Adoption/Certification Workgroup on February 25, 2010. The topic was "HIT safety." The agenda, presenters and presentations are available at this link.

At this meeting FDA testimony was given by Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health. Dr. Shuren noted several categories of health IT-induced adverse consequences known by FDA. This information was striking:

He wrote:

... In the past two years, we have received 260 reports of HIT-related malfunctions with the potential for patient harm – including 44 reported injuries and 6 reported deaths. Because these reports are purely voluntary, they may represent only the tip of the iceberg in terms of the HIT-related problems that exist.

[I'd call that a likely understatement - ed.]

Even within this limited sample, several serious safety concerns have come to light. The reported adverse events have largely fallen into four major categories: (1) errors of commission, such as accessing the wrong patient’s record or overwriting one patient’s information with another’s; (2) errors of omission or transmission, such as the loss or corruption of vital patient data; (3) errors in data analysis, including medication dosing errors of several orders of magnitude; and (4) incompatibility between multi-vendor software applications and systems, which can lead to any of the above.

This is a technology almost universally touted as inherently beneficial, right up to our most senior elected leaders, who are now pushing this unproven technology under threat of penalty for non-adopters - certainly a precedent, especially in a supposedly democratic country. I have given examples on this blog about how this belief about the universal goodness of healthcare computing is itself inherently idealistic - and unrealistic.

Now, here are some very striking, discrete examples of HIT-related adverse consequences, the tip of a larger iceberg, size unknown but quite possibly very large (where's Kate Winslet when you need her?):


(1) Errors of Commission

Example 1: An error occurred in software used to view and document patient activities. When the user documented activities in the task list for one patient and used the “previous” or “next” arrows to select another patient chart, the first patient’s task list displayed for the second patient.

Example 2: A nuclear medicine study was saved in the wrong patient’s file. Investigation suggested that this was due to a software error.

Example 3: A sleep lab’s workstation software had a confusing user interface, which led to the overwriting and replacement of one patient’s data with another patient’s study.

[I covered other examples of confusing or "mission hostile" interfaces at an eight part series here - ed.]

(2) Errors of Omission or Transmission

Example 1: An EMR system was connected to a patient monitoring system to chart vital signs. The system required a hospital staff member to download the vital signs, verify them, and electronically post them in the patient’s chart. Hospital staff reported that, several times, vital signs have been downloaded, viewed, and approved, and have subsequently disappeared from the system.

Example 2: An operating room management software application frequently “locked up” during surgery, with no obvious indication that a “lock-up” was occurring. Operative data were lost and had to be re-entered manually, in some cases from the nurse’s recollection. [I experienced similar problems: a decade ago - ed.]

Example 3: An improper database configuration caused manual patient allergy data entries to be overwritten during automatic updates of patient data from the hospital information system.

(3) Errors in Data Analysis

Example 1: In one system, intravenous fluid rates of greater than 1,000 mL/hr were printed as 1 mL/hr on the label that went to the nursing / drug administration area.

Example 2: A clinical decision support software application for checking a patient’s profile for drug allergies failed to display the allergy information properly. Investigation by the vendor determined that the error was caused by a missing codeset.

Example 3: Mean pressure values displayed on a patient’s physiological monitors did not match the mean pressures computed by the EMR system after systolic and diastolic values were entered.

(4) Incompatibility between Multi-Vendor Software Applications or Systems

Example 1: An Emergency Department management software package interfaces with the hospital’s core information system and the laboratory’s laboratory information system; all three systems are from different vendors. When lab results were ordered through the ED management software package for one patient, another patient’s results were returned.

Example 2: Images produced by a CT scanner from one vendor were presented as a mirror image by another vendor’s picture archiving and communication system (PACS) web software. The PACS software vendor stipulates that something in the interface between the two products causes some images to be randomly “flipped” when displayed.

The above is from FDA (2010 internal memo here) and by their own admission under-represents the problems, perhaps massively. Most of these errors are inexcusable from an engineering and quality perspective.

Unfortunately, there actually is no comprehensive data on the true magnitude of the problems.

44 injuries and 6 deaths: tip of the iceberg?

Merely writing about this scarcity can bring opposition. For instance, a recent paper I wrote about lack of data on unintended adverse consequences of HIT and remediation of the data paucity was rejected. (The paucity itself might be considered an 'unintended consequence' of HIT, since secrecy about pros/cons of HIT was not the intention of the medical informatics pioneers.)

One of the reasons given by an anonymous reviewer justifying rejection of the paper was itself striking:

The paper "adds little that is new or that goes beyond what a reader might find in a major city newspaper", the reviewer wrote.

Little that is new to whom, exactly? Where are the extant papers on the scarcity of such data?

I am also highly uncertain as to which "major city newspapers" the reviewer was referring to, as I've rarely if ever read articles in newspapers about the paucity of data on adverse consequences of HIT or the remediation of the paucity.

One reason for writing the paper was due to the fact the "major newspapers" - and the medical and medical informatics journals - largely avoid such issues entirely.

(The scarcity was noted by organizations such as the Joint Commission, however, in their 2009 Sentinel Events Alert on HIT - "There is a dearth of data on the incidence of adverse events directly caused by HIT overall.")

This reviewer continued with the frivolous comment that "proposing a classification of sources of unintended consequence and analysis of reasons for undereporting of each type in the resulting classification could be a useful addition to the field."

Ironically, I actually devoted an entire section of the paper to reasons for under-reporting and scarcity of unintended consequences, broadly speaking, although that this wasn't the paper's main purpose. Its purpose was to point out the dangers inherent in such an information scarcity. It is also hard to granularly classify variants of a phenomenon on which there is scarce data to begin with.

Rather than revise the paper, I may simply put it in the public domain and send it to my elected representatives involved in healthcare IT policy. I'd done this with another paper I'd written in 2007 on EMR's and postmarketing drug surveillance that had received a mysteriously similar "could have read this in any newspaper" critique.

In summary, the light is starting to shine on HIT dangers. It is also increasingly recognized by regulators such as FDA that "data scarcity" is a problem of major significance ("tip of the iceberg"), although there are those in this sector who would prefer to keep physicians and patients in the dark on this issue and keep such data scarce.

Finally, while Shuren presented a number of options regarding FDA involvement in HIT regulation, he wrote that "in light of the safety issues that have been reported to us, we believe that a framework of federal oversight of HIT needs to assure patient safety." This itself represents a major change in the culture of HIT.

Addendum: the Huffington Post Investigative Fund wrote about this meeting in an article entitled "Experts: Safety Oversight Needed as Patient Records Go Digital" here.

-- SS

For more on HIT challenges see "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties" - http://www.ischool.drexel.edu/faculty/ssilverstein/cases/