How Long Can Reusable Medical Devices Safely Last?
With limited guidance on how to validate end-of-life processing, a new study proposes a practical protocol using 100 simulated use-and-processing cycles.
Category: Regulations & Standards
Regulations & Standards
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Regulations & Standards
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ISS Solutions Achieves ISO 13485:2016 Certification
ISS Solutions has obtained ISO 13485:2016 certification, confirming its adherence to quality management standards for medical devices and ensuring their safety and reliability.
Regulations & Standards
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Joint Commission Issues Sentinel Event Alert for Surgical Fires
The Joint Commission has issued Sentinel Event Alert for surgical teams on risk factors for surgical fires and how to prevent them.
Regulations & Standards
Latest
How Long Can Reusable Medical Devices Safely Last?
With limited guidance on how to validate end-of-life processing, a new study proposes a practical protocol using 100 simulated use-and-processing cycles.
AAMI Foundation Releases Anthology of Complex Technology Solutions
The AAMI Foundation has released the last in a series of free anthologies with solutions to seemingly intractable problems with healthcare technologies.
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Library of Congress Adopts Final Rule on Fair Use of Medical Device Software
The Library of Congress published a final rule saying that accessing medical device software for the purpose of diagnosing, repair, and maintenance is considered fair use under copyright law.
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Vaccine Mandates for Healthcare Workers Gaining Momentum
A push for vaccination mandates for healthcare workers could affect those in the HTM field who work in healthcare facilities.
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FDA Hiring More Experts to Help Healthcare ‘Unleash the Power of Data’
Commissioner Hahn says the FDA is hiring the best people to analyze healthcare data to make better decisions and adapt as technology changes.
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CDRH Director Says Flexibility Key as COVID-19 Strains Regulatory System
Jeffrey Shuren says the regulatory structure for medical devices needs to change and adapt with lessons learned from the COVID-19 pandemic.
Read MoreWSO2 Launches Open Healthcare Solution
WSO2 Healthcare Solution provides a complete platform for fast-tracking API-driven compliance and digital business innovation.
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Regulations & Standards
Latest
AAMI Releases Complete Collection of Modern Dialysis Standards
AAMI is releasing Complete Dialysis Collection: 2020 edition, a comprehensive collection of 14 dialysis standards. New editions of the book will be regularly released to keep pace with the rapidly changing dialysis landscape.
