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Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers - Risk of Mortality and Stroke

FDA MedWatch -

FDA has reviewed the final results from the post-approval study conducted by SynCardia Systems, LLC. for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System). These final results indicate a higher mortality rate and higher stroke rate for patients initially supported with the C2 Driver System compared to patients initially supported with the previous generation driver, the Circulatory Support System (CSS) Console.

What can we learn from patients perspectives on the quality and safety of hospital care?

Quality and Safety in Health Care Journal -

In 2001, the Institute of Medicine defined high-quality healthcare as care that is safe, effective, patient-centred, timely, efficient and equitable.1 Subsequently, efforts to improve quality have tended to treat the six dimensions as separate rather than interrelated, with improvement in the various dimensions being pursued independently, led by different professions and occupational groups. Investment in research and improvement knowledge across the dimensions has been comparatively uneven, with little shared learning between researchers and professionals working to improve quality in one dimension about the value and efficacy of improvement approaches and methods used in others. Despite policy efforts to define quality in the round as safe, effective and patient-centred,2 3 and despite intermittent calls for patients to be involved in patient safety,4 the dimensions of quality do not have equal status within the improvement community, and patients and families do not play...


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