Is your healthcare organisation using sound quality assurance principles? Part 2: coping with the unexpected

Abstract

This is the second article in a two-part series that proposes how healthcare organisations could implement a quality assurance approach based on the requirements of a thus far unwritten healthcare modification of the 2015 International Organization for Standardization (ISO 9001). This second article will address the issue of unexpected failures of manufactured medical implants and medication delivery devices. Issues facing the quality assured supply of medical equipment, as well as the failure of implants during fitting or use and the failure or malfunction of powered syringes or drips, is discussed. At the end of the article, a list of self-audit questions is proposed to allow readers to make an assessment of how their own organisation has responded to the failure of medical implants or devices in the past, and whether action has been taken to prevent any problems reoccurring.