EHR recall: Use of this affected product may cause serious adverse health consequences, including death

Here is another example of a grossly defective health IT product, this from last year but only posted by FDA publicly on 3/14/2014 at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm389356.htm:

"There was an occurrence where the patient case data did not match the patient data when the case was recalled in the Anesthesia Care Record (ACR) in that it included data from another case. Use of this affected product may cause serious adverse health consequences, including death."

One wonders why problems like this are found in the field when real patients are involved, not in the testing lab...could it have to do with lack of regulatory oversight?

Other examples of recalled bad health IT that I know of, including FDA-initiated recalls, are here:  http://hcrenewal.blogspot.com/2012/07/health-it-fda-recall-philips-xcelera.html, http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html , http://hcrenewal.blogspot.com/2013/08/a-good-way-to-cynernetically-harm-or.html.

Also note the FDA advisory:  Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX:

http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm389328.htm 

McKesson Technologies, McKesson Anesthesia Care – Patient Case Data May Not Match Patient Data

Recall Class: Class I 

Date Recall Initiated: March 15, 2013 

Product: McKesson Anesthesia Care 

Use: The device is a computer-based system which collects, processes, and records data both through manual entry and from monitors which are attached to patients, such as in an operating room environment. The system provides clinical decision support by communicating potential adverse drug event alerts proactively during the pre-anesthesia evaluation and at the point-of-care. The system is generally indicated in the anesthetizing environment when the anesthesia provider decides to perform a patient assessment, to generate a paper and/or electronic record of the administration of anesthesia to a patient, and to document care. 

Recalling Firm:
McKesson Technologies, Inc.
5995 Windward Parkway
Alpharetta, Georgia 30005 

Reason for Recall: There was an occurrence where the patient case data did not match the patient data when the case was recalled in the Anesthesia Care Record (ACR) in that it included data from another case. Use of this affected product may cause serious adverse health consequences, including death.

Public Contact: Customers with questions may contact McKesson Customer Support at 1-800-442-6767 (option 3). For questions regarding this recall, call 404-338-3556. 

FDA District: Atlanta District Office 

FDA Comments:
On March 15, 2013, the firm initiated a Clinical Alert which was distributed to potentially affected customers. Phone calls were placed to each customer, followed up by an email. The firm provided their customers with written copies of the communication and Clinical Alert; and obtained acknowledgement that they read and understood the issue and preventive action to take.

Customers with questions were instructed to contact McKesson Customer Support at 1-800-442-6767 (option 3). For questions regarding this recall, call 404-338-3556.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. 

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

I encourage clinicians to take advantage of MedWatch with regard to bad health IT, anonymously if necessary to avoid internal repercussions or retaliation from executives who've spent hundreds of millions of dollars on the IT, and whose bonuses and promotions might be tied into its "success."

-- SS