Although most, if not all, of the IT systems used in Hospitals do not fall into the category of medical devices themselves there are a lot of similarities between the two.
Many hospitals in the US are already undergoing extensive IT expansion, so than most of the medical devices can be linked to the main hospital IT system. This will allow real time remote monitoring and automated EHRs, but it will also open the system to new failures.
As you can imagine, failures of Health IT systems potentially can result in harms to the patients, even at a broader scale.
For example, the Irish HSE (Health Service Executive) discovered only recently that the NIMIS system, used to store and collaborate on electronic diagnostic images, accidentally left out a “<” character from the patients’ radiology reports of the last 6 years. This resulted in up to 25’000 patients potentially being given an incorrect treatment or being misdiagnosed. This, in a country of only 4 and a half million people.
One of the most important aspects of the development of such systems is the focus on risk management activities. Some countries have specific guidelines for risk management for Health IT systems, such as the SCCI0129 in the UK, where the risk management process relies heavily on the requirements of ISO 14971.
The process begins with the identification of potential hazards, their severity, an initial evaluation, risk control actions and final evaluation. Including a plan and a report, with risk/benefit analysis.
Some of the wording and terminology can be a bit different, but the spirit is the same.
Good understanding of ISO 14971 and the use of appropriate software tools for risk management can alleviate some of the burden associated with these activities, while ensuring the correct required compliance.
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