Medical device regulations and patient safety

Abstract While medical device regulations govern manufacturers to ensure product safety, risk management processes in healthcare facilities ensure patient safety in using medical devices. The regulatory and organizational processes are complementary in optimizing patient safety outcomes. Although there are other stakeholders, risk management of medical devices is the principal responsibility of clinical engineering (CE) services professionals in healthcare facilities. In addition to informing CE services, this article uses medical device regulatory concepts for the purposes of demonstrating to healthcare decision-makers that CE services constitute an essential continuum of activities to ensure patient safety. Effective and principled CE services, in turn, gives the medical device regulations greater effect by translating product safety to patient safety.