A clinical engineering initiative within the Irish healthcare system toward a safer patient environment

Abstract

Clinical Engineering within Ireland has developed significantly in recent years. This Engineering discipline has proven an essential component of the modern healthcare environment. Nationally, Clinical Engineers participate as key members within multidisciplinary teams of every Clinical specialty. The Clinical Engineering membership has developed to include participants from the areas of Healthcare institutions, community medicine, academia and the medical device industry. A national voluntary registration scheme is now established and will further contribute to the professional development of Clinical Engineering. Central to the profession of Clinical Engineering is Patient Safety and pivotal to this responsibility are the many elements of effective medical device management. Medical devices are both manufactured and utilized within Ireland under three different European Directives, the Medical Devices Directive, 93/42/EEC, 90/385/EEC for active implantable medical devices and 98/79/EC for in-vitro diagnostic medical devices. These directives are enacted into Irish Law. To fully ensure compliance with these directives a Clinical Engineering Department within an organization or community must be aware of all the Medical Devices within its remit. Only then can the medical devices be effectively managed, ensuring a medical device is safe for both patient and clinical user and the treatment being administered or diagnosis being acquired is both safe and accurate. The Adelaide and Meath Hospital, Dublin, incorporating the National Children’s Hospital, (AMNCH), instigated a Medical Device Audit, as part of a Six Sigma Process Improvement initiative. This audit was an element of a larger Clinical Engineering process improvement initiative. The results indicate the importance of this initiative in establishing the identity and quantities of medical devices within an organization. It is only with this essential knowledge that medical devices can be effectively managed and an organization can meet its statutory responsibility.