How safe is the safety paradigm?

This paper reviews safety initiatives in the health systems of the UK, Canada, Australia, and the US. Initiatives to tackle safety shortcomings involve public-private collaborations. Patient safety agencies (to institute learning, action and safety culture), adverse event reporting and, to a lesser extent, safety related performance indicators are currently used to design safer health systems. Their benefits are mixed, but there is little debate as to their possible side effects. Foreseeable adverse effects of multiple safety organisations stem from them being too many, too vague, too narrowly focused, threatened by the medical practice environment, and too optimistic. Safety related performance indicators are most developed in the US but suffer from inadequacies of administrative data, underreporting, variable indicator definitions, "extended" use, and low sensitivity of the diagnosis coding system, and arguable preventability of the prescribed conditions. A critical appraisal of the implications of these deficiencies is important to assure the safety of current health system safety initiatives and to establish evidence based safety. It is necessary to embed health system safety (as well as patient safety) in the societal culture, structures, and policies which promote effective, user centred, high performance care while allowing for healthy innovation.