AAMI News December 2019

AAMI Resources to Add to Your Holiday Wish List

Are you looking for a gift for your colleagues, or perhaps for yourself? Consider one of the newest publications on health IT, quality systems, risk management, artificial intelligence, and other healthcare technology topics—available at the AAMI Store.

Holiday GiftsANSI/AAMI ST79:2017

ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, is THE go-to reference for steam sterilization and sterility assurance in all healthcare facilities, regardless of sterilizer or facility size. Developed by industry experts, regulators, and sterilization professionals, this standard will guide you through every step of the steam sterilization process.

PRODUCT CODE: ST79 or ST79-PDF

AAMI HIT1000-3(PS):2019

HIT1000-3, Safety and effectiveness of health IT software and systems—Part 3: Application of risk management, specifies a process for identifying the patient safety hazards associated with health IT software and systems, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the
controls.

PRODUCT CODE: HIT10003PS2019

The Quality System Compendium, 4th Ed.

The latest edition of the Quality System Compendium provides a comprehensive view of the rapidly evolving world of international medical device regulations. Since the 2015 publication of the third edition, the medical device regulatory landscape has undergone fundamental changes that impact many aspects of the global medical device community.

PRODUCT CODE: QSC4 or QSC4-PDF


ANSI/AAMI/ISO 13485:2016/(R)2019

Medical devices—Quality management systems—Requirements for regulatory purposes specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

PRODUCT CODE: 134852019PDF

Artificial Intelligence and Machine Learning

This position paper covers the emergence of artificial intelligence and machine learning in healthcare and offers recommendations to support governance and regulation. The paper also summarizes key discussion points from the collaborative activities undertaken by BSI and AAMI, with support from the Medicines and Healthcare products Regulatory Agency.

PRODUCT CODE: AIPAPER2019

ANSI/AAMI ST90:2017

ST90, Processing of health care products—Quality management systems for processing in health care facilities, specifies minimum requirements for quality management systems to effectively, efficiently, and consistently process (transport, clean, decontaminate, disinfect, inspect, package, sterilize, and store) medical devices to prevent adverse patient events and non–manufacturer-related device failures.

PRODUCT CODE: ST90 or ST90-PDF

Healthcare Technology Management Manual

Take your HTM department to the next level. The 2019 edition of the Healthcare Technology Management Manual, the successor to the popular Medical Equipment Management Manual, can help you get there. This edition covers “all aspects of running a successful HTM department,” from accreditation and standards to HTM operations, personnel, and services, according to author Al Gresch, vice president of client success at Accruent.

PRODUCT CODE: HTMM or HTMM-PDF