Purchasing for Safety: A Human Factors-Influenced Procedure for Evaluating Medical Products

Abstract

Safety reports related to products and devices used in health care have demonstrated that not all items can be considered equal in terms of usability, compatibility, and functionality, which can result in patient safety concerns. Hospital systems use a wide variety of products when providing care to patients. This variability may contribute to purchasers failing to fully understand and define the needs for these products. In addition, it is necessary to define what a high-quality product is, including what minimal technical requirements it must meet. The Veteran’s Health Administration (VHA) is the largest health care system in the United States; as such, it possesses the ability to learn from a large group of health care providers as well as a great deal of purchasing power. Purchasing for Safety is a procedure for investigating medical devices or products with an end goal of improving the purchasing decision. Purchasing for Safety can help hospitals and health care systems to systematically evaluate medical products and devices for issues that may lead to patient safety concerns. By conducting careful testing and documenting methods and findings, the test team can assist stakeholders in making purchasing decisions that may ultimately result in better patient care. The greater formality introduced in Purchasing for Safety will help hospitals justify purchasing decisions, and the thoroughness of the investigation will promote patient safety.

Prioritizing Patient Safety: Analysis of the Procurement Process of Infusion Pumps in Spain

“…Despite the mentioned recommendations, some data suggest that patient safety is not usually considered a relevant driver of healthcare technology procurement [30]. After detecting several safety incidents related to infusion pumps, the Healthcare Safety Investigation Branch [31] launched an investigation into the NHS to understand the emerging risks and barriers to the safe introduction of the technology and how data may help to demonstrate effectiveness.…”

“…Several reports have been published about human factors evaluation, specifically of infusion pumps, related to the comparison of different equipment [34], for improving existing designs [11] or for supporting new designs [35,36]. However, human factors evaluation is not a usual practice as a supporting decision tool in medical technology in general [30]. Most medical technology procurement is driven by engineering standards, and the emphasis is on functional requirements rather than those relating to social or organizational needs [37].…”

Prioritizing Patient Safety: Analysis of the Procurement Process

“…Despite the mentioned recommendations, some data suggest that patient safety is not usually considered as one relevant driver of healthcare technology procurement 30 . One investigation of the Healthcare Safety Investigation Branch 31 found that the procurement of smart pump technology is not primarily driven by the need for smart functionality and was not subjected to a risk assessment or requirements analysis.…”

“…Several reports have been published in relation to human factors evaluation, speci cally of infusion pumps, related to the comparison of different equipment 34 , for improving existing designs 11 or for supporting new design 35,36 . However, human factors evaluation is not a usual practice as a supporting decision tool in medical technology in general 30 . In fact, most medical technology procurement is driven by engineering standards, and the emphasis is on functional requirements rather than those relating to social or organizational needs 37 .…”

Guidance for Selecting Health Care Products Using Human Factors Techniques

“…The Veterans Health Administration (VHA) has a duty to the Veteran patient, the provider, and the taxpayer. Previously, the authors described the "Purchasing for Safety Model," a method for medical device and product investigation prior to purchase (Fuller et al, 2017). This proactive method for assessing risk requires a substantial investment in terms of personnel time and expertise.…”