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FDA Considering Health IT Regulation
Last year as a result of Health IT problems - the FDA received notice that
six people had died and another 44 were injured. The Agency believes however
that the problem is more serious than they have visibility. “"Because these
reports are purely voluntary, they may represent only the tip of the iceberg in
terms of the problems that exist," says Jeffrey Shuren, director of the FDA's
Center for Devices and Radiological Health.
The adverse events come on the cusp of a review by the Agency on the ever
evolving world of Hospital IT networks. A major issue involves determining the
electromagnetic compatibility between electronic devices and the requirements
for risk management of IT networks that incorporate medical devices. A standard
IEC 80001 addresses these very requirements and enables manufactures to
adequately design medical devices with consideration regarding other devices.
For instance, do the devices produce significant electromagnetic radiation in a
place that can adversely affect devices such as pacemakers or other hospital
related equipment?
The IEC 80001 defines three levels of risk management that are areas where
medical device manufacture engineers are directed to define risk. The first
level addresses risk to the patient – or patient health. This addresses issues
associated on how the device is likely to affect patients (i.e. effect on
pacemakers, ICU medical devices, etc). The second level addresses risk
associated with interference with Hospital staff’s ability to function properly.
The third level defines risk associated with protecting the integrity of patient
data – a growing area of concern with the advent of the electronic patient
record (EPR) and the evolving Picture Archiving and Communications Systems ({PACS)
and the systematic conversion of conventional radiology to digital format.
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