Introduction: Adverse events (AEs) leading to harm to patients are prevalent across health care. However, a considerable share of AEs are preventable. Failure Mode and Effect Analysis (FMEA) has been effectively used to enhance patient safety and quality. Failure Mode and Effect Analysis (FMEA) has been effectively used to enhance patient safety and quality. This scoping review aims to provide an overview of the studies reporting the use of FMEA, failure mode and criticality analysis (FMECA), and health care Failure Mode and Effect Analysis (HFMEA) in pediatric and adolescent hospital care.

Methods: We conducted a systematic search of Web of Science, Scopus, Embase, Cochrane, CINAHL, and PubMed for relevant literature published since 1999. Papers were analyzed based on the FMEA process steps.

Results: Eighteen papers were included in the review, assessing 21 processes, primarily involving drug prescribing, dispensing, and administration. Participants in the risk assessment came from various occupational groups. Risk priority numbers varied based on severity, occurrence, and detection. A total of 220 high-risk risk priority numbers were identified. Improvement actions had not been systematically reported.

Conclusions: FMEA, FMECA, and HFMEA were successfully used to ensure patient safety in pediatric and adolescent hospital care. These methods can be used to effectively identify possible failures in healthcare processes and in quality improvement and risk reduction. They also enable prioritizing the targets of improvement actions. In addition, the use of risk analysis methods may result in increased awareness of potential safety risks among the workers who have participated in risk assessment.

Keywords: Failure Mode and Criticality Analysis; Failure Mode and Effect Analysis; Healthcare Failure Mode and Effect Analysis; patient safety; pediatrics; risk management; scoping review.