Date of Award
Spring 2025
Project Type
Clinical Doctorate
Abstract
Background: The currently established product surveillance process at Boston Scientific is a reactive one which presents compliance risks, patient safety risks, and quality risks. Evolution to a proactive process is necessary to protect public health, allow for commercialization of devices that have a robust safety, reliability, and efficacy profile, and to identify and react to risk before or at the early stages of a problem.
Methods: A pre-implementation survey of baseline opinions associated with decision-making, efficiency, effectivity, and safety of the current product surveillance system was performed. A baseline time study was performed associated with the process, which was separated into four parts, input of patient data, alignment of data, obtaining reports, and comparting data to established thresholds. This data was obtained and utilized within a Kaizen event to identify three key interventions.
Interventions: The first intervention was to develop standard lists associated with codes (device, patient, and impact), hazards, and harms so that the product surveillance processes, and the complimentary processes speak the same language. Second, roles and responsibilities within the product surveillance process were adjusted so that the appropriately credentialed resources were reviewing and processing incoming events. Third, the data fields where new information was entered by the medical safety health care professionals were mapped within the reporting tool so that the new bits of data can be obtained within the existing reports and utilized for assessing data at various on-demand time periods.
Results: The measures associated with the survey, compliance, and time studies showed improvement beyond the established goals. The time study data resulted in improvements that can be deemed statistically significant. As evidenced by the measures it was shown that a proactive surveillance process was established.
Conclusions: The purpose of this quality improvement project was to enhance the ability to survey and react to patient safety signals within a medical device manufacturer by developing, implementing, and evaluating an integrated product surveillance process. The intervention measurement outcomes showed that via implementation of a few key process changes Boston Scientific was able to shift the product surveillance process to a proactive one that upholds patient safety, compliance, and quality.
Recommended Citation
Boisvert, Kaylee, "An Integrated Approach to Patient Safety in the Medical Device Industry: A Quality Improvement Project" (2025). DNP Scholarly Projects. 123.
https://scholars.unh.edu/scholarly_projects/123