Applicability of Healthcare Failure Mode and Effects Analysis to Healthcare Epidemiology: Evaluation of the Sterilization and Use of Surgical Instruments

Abstract

Healthcare Failure Mode and Effects Analysis (HFMEA) is a methodology for correcting latent system errors before they lead to adverse events. We examined the utility of HFMEA in evaluating the sterilization and use of surgical instruments. First, a multidisciplinary team graphed the process in a flow diagram. A hazard analysis was then used to examine potential failure modes (i.e., ways in which a process can fail) and their causes and to score the severity and other factors for each failure mode cause. Actions were then planned to address the selected failure mode causes. Flow charts were created for 3 foci: sterilization process, reading of biologicals, and use of equipment. Information was gathered through interviews and a review of the literature. Multiple clinically significant system errors were identified, and actions to correct them were developed. The HFMEA methodology facilitated the detection of previously unrecognized system errors, demonstrating its potential utility in addressing healthcare epidemiology-related adverse events.

Risk assessment of the emergency processes: Healthcare failure mode and effect analysis

“…Also, in HFMEA studies, it is diffi cult to show the reduction of adverse events after interventions and to prove the improvement of patient safety and cost-benefi t analysis with HFMEA programs. [26] "Creation and revision of the approaches and a clear implementation method", "education of the patients and patients' participation in treatment process", "revision and re-engineering of processes", "basic analysis of the events and report of the critical results", "continuous monitoring and control of the working stages", "improvement of team communication", "check-list of maintaining and management of equipment", "development of the evaluation criteria of staff performance", and "adapting workload with the staff" should be applied for optimization and to improve the quality of emergency surgical processes. Finally, the effectiveness of the mentioned method in the implementation step was not tested in this study.…”

“…Redesigning the process and improving strategies for each cause of error with a score≥8 in the team meetings through "theory of problem solving by an inventive method" [26,27] were provided and classifi ed with inspiring by the proposed model of "classification of preventive strategies in incidence of medical errors". [9,28] Finally, the practicability of implementation of any approach with regard to resources of the organization were evaluated.…”

A comparison of two prospective risk analysis methods: Traditional FMEA and a modified healthcare FMEA

“…First, the categories for frequency of occurrence are changed into easily defined categories in order to prevent team members from placing their own interpretation on the categories. [11][12][13][14][15][16][17][18][19] For instance, categories such as "less than once a year," "yearly," "monthly," "quarterly," and "weekly" are used instead of HFMEA™ categories such as "remote," "uncommon," "occasional," and "frequent." Second, the numbers in the HFMEA Hazard Scoring Matrix™ are replaced by arbitrary risk scale such as very low, low, high, and very high with accompanying red or green box, while the HFMEA™ originally used a numerical classification with more discrete levels that allows for more subtle differentiation between risks.…”

“…11,12 HFMEA™ has been successfully applied to several healthcare processes, such as drug ordering and administration and sterilization and use of surgical instruments. 13,14 However, the main constraints often reported when conducting an HFMEA are the significant time commitment and resources needed. [15][16][17][18] The risk analysis has been streamlined further into a faster version of HFMEA™, called scenario analysis of failure modes effects and risks (SAFER), which is promoted in the Netherlands.…”

Paramedic Myocardial Infarction Care with Fibrinolytics: a Process Map and Hazard Analysis

“…11 Specifically, the Healthcare Failure Mode Effects Analysis (HFMEA), a systematic method of identifying and preventing process and outcome adverse events before they occur, has been used to assess a wide variety of health care processes, including iv infusions, trauma patient registration, care of critical care medicine patients, and sterilization of surgical instruments. [12][13][14][15][16] HFMEA has been applied to out-of-hospital rapid sequence intubation, a complex intervention administered by advanced-level paramedics. 17 Process maps are valuable not only to recognize points in the process where errors currently occur, but, more importantly, to prospectively identify time points most vulnerable to adverse events, termed hazard modes (HMs) in the HFMEA method.…”