The Compounding Power of the Clinical Community

Abstract

Healthcare technology management (HTM) professionals are critical stakeholders in promoting patient safety, regularly troubleshooting medical devices that are unsafe or unable to be used by clinical staff. Healthcare technology management professionals determine, investigate, and often address the root cause (or causes) of medical device concern(s), so that the devices can be used safely and effectively throughout the facility. The HTM professional's investigation, when accompanied by medical device reports, often leads to manufacturer actions, including recalls and corrections, which contribute to continuous improvement of device safety and performance. As highlighted in this case report, healthcare facility reporting teams, which include HTM professionals, provide value to the healthcare community as a whole, affecting real-world outcomes and patient safety.

Reporting Medical Device Events

“…3 Because FDA receives a large volume of reports, this definition helps the Agency hone in on medical device events that are especially serious to the public health. An example of a mandatory reportable event is highlighted in the article titled: "The Compounding Power of the Clinical Community," 4 in which a user facility reported on the death of patient, as a result of an endotracheal tube disconnection that disrupted the breathing circuit. The thorough event description provided in the report along with the facility's in-house clinical engineering analysis into the possible root cause and scope of disconnections helped to contribute to a manufacturer recall of 34 endotracheal tube products with notification letters sent to all customers to discontinue use immediately.…”