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

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

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