Below are excerpts from GE’s statement to the Investigative Fund regarding adverse event reports submitted to the FDA about its health information technology devices.

GE Healthcare is dedicated to providing safe and effective products. 

In Spring 2008, the FDA conducted a general inspection of the Barrington, Ill. GE Healthcare IT facility.  This was a routine inspection, consistent with FDA laws requiring all device manufacturers to undergo periodic inspection and was the first FDA inspection of this particular facility.   

As part of this inspection, the FDA investigator issued a form FDA 483, which listed observations that warranted correction and, later, the FDA issued a Warning Letter.  None of the identified issues impacted patient safety.   The FDA visited for a follow-up inspection in 2009, deemed GE Healthcare IT to be compliant, and now considers the matter closed, without issuing a single fine or sanction. 

…It is important to note that there are various situations in which recalls involving free-standing software systems can occur.‬

First, there are instances where some providers use software in workflows that are unanticipated at the time of design. A recall enables the company to make modifications to enable the new workflow.

Second, as part of our ongoing quality improvement processes we continually examine and re-examine our software to identify potential areas for improvement and make preemptive corrections prior to any issues occurring. 

It is, primarily, these two types of situations that have led to recalls since the 2008 FDA inspection.

…Over the past several years, GE Healthcare has made tremendous investments to strengthen its quality systems…

GE Healthcare holds nothing higher than its commitment to quality and safety. We emphasize timely reporting of product issues, and appropriate corrective actions. The clinical environment in which healthcare IT products are used continues to evolve and develop. We are dedicated to examining and re-examining our software products to identify potential areas for improvement, and make proactive corrections prior to any issues occurring.

• Related Topics: Electronic Medical Records, Electronic Medical Records

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