Failure Mode, Effects and Criticality Analysis (FMECA) for Medical Devices: Does Standardization Foster Improvements in the Practice?

Risk analysis techniques received increasing attention in the health care sector in the last 30 years. These techniques are diffused for health care processes, and less for devices. In fact, risk management for medical devices was introduced only recently (ISO 14971 in 2000 and GHTF/SG3/N15R8 in 2005) [1,2]. The goal of this study is twofold. First, we aim at evaluating the state of the art of the diffusion of standards for the risk assessment of medical devices (with a focus on FMECA). Second, we evaluate the impact of risk assessment techniques on the practice. To pursue the first goal, a literature review has been performed through the investigation of medical and non-medical databases. To reach the second objective, we selected a leading Company in the development of medical devices and we investigated the process enacted to evaluate the risk connected to the design of new devices. The literature search confirmed the widespread application of the FMECA, the scant number of contributions about its applications on medical devices, and the main limitations related to the use of this technique. The empirical investigation showed that the Company spends a surprising amount of time and resources to set and deploy the FMEA rigorously, and it follows the passages envisioned by the literature carefully, with the unique intent to respect the standards. A gap emerges among the practitioners and academic words, with two possible explanations. First, the academics are not addressing the managerial and practical implications of their contributions; in so doing they deepen the “theory versus practice” chasm. Second, the presence of standards actually discourages the practitioners to push over and find new solutions.