ECRI 2015 Patient Safety Concerns

ECRI has released their top 10 Patient Safety Concerns for 2015. Second on the list is “Data Integrity: Incorrect or missing data in EHRs and other HealthIT systems”. While we are not surprised to see this area of patient safety risk on the list, SoftwareCPR believes that many of these data integrity hazards could easily be eliminated or risk reduced through simple to implement active risk controls designed into the software during development. Simply arguing that Design Controls and risk management requirements will “slow down” the development of HealthIT, is a poor excuse for not adding simple data integrity checks and defensive coding practices. IEC/TR 80001-2 (or AAMI TIR32) is an excellent resource to help your team identify these hazards and provides common risk control methods. SoftwareCPR experts can perform data integrity assessments or help you define effective data integrity risk control control measures as part of your design and risk management.

A PDF with the Top 10 Patient Safety Concerns for Healthcare Organizations can be found at: 2015_Patient_Safety_Top10

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:

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