Strategies to increase patient safety in haemodialysis: Application of the modal analysis system of errors and effects (FEMA system)

Background: Haemodialysis (HD) patients are a high-risk population group. For these patients, an error could have catastrophic consequences. Therefore, system that ensures the safety of these patients in an environment with high technology and great interaction of the human factor is a requirement. Objectives: To show a systematic working approach, reproducible in any HD unit, which consists of recording the complications and errors that occurred during the HD session; defining which of those complications could be considered adverse event (AE), and therefore preventable; and carrying out a systematic analysis of them, as well as of underlying real or potential errors, evaluating their severity, frequency and detection; as well as establishing priorities for action (Failure Mode and Effects Analysis system [FMEA systems]). Methods: Retrospective analysis of the graphs of all HD sessions performed during one month (October 2015) on 97 patients, analysing all recorded complications. The consideration of these complications as AEs was based on a consensus among 13 health professionals and 2 patients. The severity, frequency and detection of each AE were evaluated by the FMEA system. Results: We analysed 1303 HD treatments in 97 patients. A total of 383 complications (1 every 3.4 HD treatments) were recorded. Approximately 87.9% of them were deemed AEs and 23.7% complications related with patients' underlying pathology. There was one AE every 3.8 HD treatments. Hypertension and hypotension were the most frequent AEs (42.7 and 27.5% of all AEs recorded, respectively). Vascular-access related AEs were one every 68.5 HD treatments. A total of 21 errors (1 every 62 HD treatments), mainly related to the HD technique and to the administration of prescribed medication, were registered. The highest risk priority number, according to the FMEA, corresponded to errors related to patient body weight; dysfunction/rupture of the catheter; and needle extravasation. Conclusions: HD complications are frequent. Consideration of some of them as AEs could improve safety by facilitating the implementation of preventive measures. The application of the FMEA system allows stratifying real and potential errors in dialysis units and acting with the appropriate degree of urgency, developing and implementing the necessary preventive and improvement measures. (c) 2017 Sociedad Espanola de Nefrologia. Published by Elsevier Espana, S.L.U.