Is your organization ready to support safety-critical systems?
By Tim Gee
With certain patient safety issues, the “system” is responsible for the root cause of a problem rather than the actions of those participating in the situation resulting in an adverse event. Clinical activities to which “the system” may contribute risk include patient handoffs between clinicians, medication administration, diagnosis of disease, and many others.
A system-based patient safety risk that has been emerging in the healthcare industry for some time—mostly unrecognized and inadequately addressed—is a gap in the governance of automated technologies in hospitals. This emerging risk is a consequence of progress in automating healthcare workflows and processes. Automation has moved beyond patient accounting, order entry, and results reporting to embrace remote surveillance, alarm notification, smart pumps, and clinical decision support systems. These systems meet the legal definition of a medical device, are regulated by the Food and Drug Administration (FDA), and can represent considerable risk to patient safety. The systemic patient safety risk arises from how these medical device systems are managed and supported. The relevant systems can be divided between medical device systems and medical device software.
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About The Author:
Tim Gee is principal and founder of Medical Connectivity Consulting (www.medicalconnectivity.com) where his practice revolves around workflow automation through the integration of medical devices with information systems and enabling technologies. Gee is the 2012 recipient of the American College of Clinical Engineering’s Challenge Award and is program chair and principal organizer for the Medical Device Connectivity conference. Gee writes at the Medical Connectivity blog, serves on the editorial advisory boards of a number of publications including Patient Safety & Quality Healthcare, and participates in key industry interoperability development efforts. He may be contacted at tim@medicalconnectivity.com.
