Failure to inform the FDA about a medical device correction or removal has earned Merge Healthcare, a developer of medical image handling and processing, interoperability and clinical systems, a warning letter. Word of the letter came just as IBM closed its deal to buy Merge, which will become part of IBM’s new Watson Health business for $1 billion.

According to a warning letter dated Sept. 30, the company issued two notices — one in January and one in April — related to Merge Hemo, which is used as a tool to collect data into the digital patient record. The warning letter states that, in some instances, computers either froze or took multiple short readings of invasive blood pressure as the devices were being used on patients. As a result of having to reboot the systems, patients’ vital signs were lost.

The FDA ultimately determined the company’s actions with the Merge Hemo constituted a Class 2 recall. The letter chides the company for not alerting the agency about the device correction or removal.

QS Problems

During the June 3 to July 27 visit to the company’s Hartland, Wisc., facility, the FDA inspector also found some quality systems issues. Specifically, the inspector determined the company had failed to review and evaluate complaints related to the failure of a device and its labeling.

It also didn’t establish adequate procedures for reviewing these complaints by a formally designated unit.

In a response dated Aug. 12, the company said it was committed to updating its complaint handling procedure. The agency deemed the response inadequate, saying that it failed to update its complaint handling procedure.

Further, the company’s response didn’t include a commitment to performing a retrospective review of quality data sources to ascertain whether there are other complaints that haven’t been appropriately documented or provide a timeframe for establishing a unit to handle complaints.

Design Validation

Also, the company failed to adequately establish procedures for design validation. Specifically, the company allows for devices that have not completed design validation, including software validation, to be shipped to end users for clinical use on patients in a limited availability basis to collect additional feedback prior to the completion of design validation, according to the letter. One product was shipped for clinical use in cardiac catheterization procedure labs under such a release, the FDA says.

While the company says it is committed to updating the design validation procedure, the FDA has determined that its response is inadequate, as it has not provided an implementation timeframe. Further, it doesn’t discuss whether other in-progress projects may be affected by the elimination of the limited availability release.

The FDA also chides the company for not documenting design review results, including the date, in the design history file. 

According to the letter, records fail to indicate when design reviews were conducted or their result. In its response, the company didn’t give an updated procedure for review or a plan for revisiting competed design projects.  

The company is committed to implementing corrective actions to ensure compliance with the Federal Food, Drug, and Cosmetic Act and all regulatory requirements, Justin Dearborn, chief executive officer of Merge Healthcare, says. He adds that company management will work with the agency to ensure the matter is resolved expeditiously.

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