Toward safer health care: a review strategy of FDA medical device adverse event database to identify and categorize health information technology related events.

INTRODUCTION: Health information technology (HIT) is intended to provide safer and better care to patients. However, poorly designed or implemented HIT poses a key risk to patient safety. It is essential for healthcare providers and researchers to investigate the HIT-related events. Unfortunately, the lack of HIT-related event databases in the community hinders the analysis and management of HIT-related events.

OBJECTIVES: Develop a standardized process for identifying HIT-related events from a Federal Drug Administration (FDA) database in order to create an HIT exclusive database for analysis and learning.

METHODS: The FDA Manufacturer and User Facility Device Experience (MAUDE) database, containing over 7-million reports about medical device malfunctions and problems leading to serious injury or death, was considered as a potential resource to identify HIT-related events. We developed a strategy of identifying and categorizing HIT-related events from the FDA reports through the application of a keyword filter and standardized expert review. Ten percent identified reports were reviewed to measure the consistency among experts and to initialize a database for HIT-related events.

RESULTS: With the proposed strategy, we initialized an HIT-related event database with over 3500 reports, and updated the estimation of the HIT-related event proportion in the FDA MAUDE database to 0.46∼0.69%, up to 50,000 HIT-related events.

CONCLUSION: The proposed strategy for HIT-related event identification holds promise in aiding the understanding, characterization, discovery, and reporting of HIT-related events toward improved patient safety. The analysis of contributing factors under the 8-dimensional sociotechnical model shows that hardware and software, clinical content, and human-computer interface were identified more frequently than the other dimensions.