The Role of Patient Safety in the Device Purchasing Process

To examine how patient safety considerations are incorporated into medical device purchasing decisions, individuals involved in recent infusion pump purchasing decisions at three different health care organizations were interviewed using a structured interview process. Interview questions covered triggers for the purchasing process; the purchasing process itself; how safety was evaluated and incorporated into the process; and the perceived decision and process quality. The results show strengths and weaknesses within the processes. Strengths included (1) a general perception that patient safety was important and played a role in the decision; (2) the inclusion of a wide range of stakeholders in the decisionmaking process; and (3) the use of device user feedback as a component of the device evaluation process. Weaknesses included (1) safer devices may have been overlooked, as very few alternative devices were considered; (2) two important stakeholders, device users and patients, did not participate directly in the purchasing decisions; (3) the device selected for purchase often was determined before the evaluation process had been completed, and the evaluation process then was used to justify the selection decision; (4) although participants felt they had considered device safety, the device evaluation often was limited to technical safety issues, such as operating to technical specifications, rather than device interface issues that may induce or prevent device usage errors; and (5) no explicit, formal usability testing was conducted at any of the three sites for the purpose of assessing device safety. These weaknesses underscore the need for guidelines and tools to help health care employees better assess issues central to patient safety during the device purchasing process.