By M. Robert Blanchard
October 31st, 2012 8:00am
The FDA announced yesterday a Class 1 recall of a touchscreen used in medical care. Attached to the Symbiq medication pump, the touchscreen may have a delayed response or may enter data different from that intended by the user. The pump is used for multiple types of therapies across the medical field and the mis-administration of pharmaceutical products to a patient could result in injury or death. The company known as Hospira has agreed to a voluntary nationwide recall.
This recall may signal coming problems with the trend towards touchscreen devices. In the past, medical devices would be set by a series of buttons, a full keyboard, or a press and select menu system. As anyone who has tried typing on iPhone knows, typing data into a touchscreen is an entirely new prospect. With an iPhone, complex correction systems guess what the user intended and suggest correctly spelled words. When it comes to the entry of medically crucial data, the solutions are not so simple. Designers hope to implement a series of safeguards, such as confirmation of data entry and comparison of these entries to what would be an acceptable range for a given patient. However, with multi-use devices, and touchscreens attached to multiple devices, the challenges will not be easily overcome. This is a whole new area requiring FDA oversight.
On August 29, 2012, Hospira mailed an Urgent Device Correction letter [see link in Recall Notice] notifying customers of this recall of its Symbiq infusion pump. Errors of the Symbiq touchscreen in registering user input could result in an interruption in treatment or over delivery or under delivery of medication if the user does not confirm the programmed values on the pump’s confirmation screen before starting the infusion. The full text of the recall can be found at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm326080.htm?source=govdelivery .
M. Robert Blanchard is a former prosecuting attorney, trail lawyer and writer living in Gulf Breeze, FL.
More information on medical device recalls.