ECRI Top Ten Safety Safety Concerns.

ECRI Institute published its Top 10 Patient Safety Concerns for Healthcare Organizations to give healthcare organizations a gauge to check their track record in patient safety. The list originally appeared in its Healthcare Risk Control (HRC) System newsletter, the Risk Management Reporter, and is reprinted in this report. The list is partly based on more than 300,000 patient safety events, custom research requests, and root- cause analyses submitted to our federally designated patient safety organization, ECRI Institute PSO, for evaluation and analysis.

The number 1 issue on the list is data integrity failures with Health IT systems.

ECRI intends to publish its top 10 list of patient safety concerns on an annual basis and recommends using it along with ECRI Institute’s other two top 10 lists: list of health technology hazards and ar list of technologies to watch to stay informed in all areas of patient safety.

The PDF can be viewed here: ECRI_Top10_0414

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IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

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