Another health IT FDA recall notice, this time on middleware, an interface engine that routes data:
Week of July 11
Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange [a specialized computer and accompanying software package - ed.]. Philips Xcelera Connect R2.x is a generic interface and data mapping engine between a Hospital Information System (HIS), Imaging Modalities, Xcelera PACS and Xcelera Cath Lab Manager (CLM). This interface engine simplifies the connection by serving as a central point for data exchange. The data consists only of demographic patient information, schedules, textual information and text reports.
Classification: Class II
|Reason For Recall||Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface|
The data consists "only" of demographic patient information, schedules, textual information and text reports?
This is a dangerous fault mode, indeed.
"Incomplete information" moving between a hospital information system, imaging systems, a PACS system used to manage the images, and a cardiac cath lab can lead to very bad outcomes (and million dollar lawsuits), such as at "Babies' deaths spotlight safety risks linked to computerized systems", second example.
Note that the interface engine is in release 2.1, level 1, service pack 2.
In other words, a critical hardware/software product such as this undergoes constant tweaking (like Windows).
As a Class II device, at least the software is vetted to some degree by FDA:
Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances. In addition to complying with general controls, Class II devices are also subject to special controls. A few Class II devices are exempt from the premarket notification. Special controls may include special labeling requirements, mandatory performance standards and postmarket surveillance. Devices in Class II are held to a higher level of assurance than Class I devices, and are designed to perform as indicated without causing injury or harm to patient or user. Examples of Class II devices include powered wheelchairs, infusion pumps, and surgical drapes.
One wonders how testing of tweaks and updates to this product is done, if at all, other than on live and unsuspecting patients.
When you go into the hospital you are not just putting your life in the hands of the doctors and nurses, you're putting your life into the hands of computer geeks and software development experiments.
July 25, 2012 Addendum:
The WSJ covered this here: http://blogs.wsj.com/cio/2012/07/20/philips-recalls-flawed-patient-data-system/. From their report:
... The problem that led to the recall: hitting the “enter” button, to start a new paragraph, in the summary field of heart test reports, sometimes caused the text entered below that point to be stripped from the report as it was transmitted into the patient’s electronic health record. And doctors later reviewing the patient’s electronic health record would not necessarily know they had received only part of the report, which could lead them to make “incorrect treatment decisions,” Philips said in a letter to hospitals.
... Mike Davis, managing director at The Advisory Board Company, a healthcare research firm, says in the case of the Xcelera Connect, Philips should have caught the problem in testing. “How the hell does this get out? It shows there wasn’t good quality assurance processes in place.”