2018 Catalog Standards, Books, & Education

Transcription

1 Advancing Safety in Health Technology 2018 Catalog Standards, Books, & Education New and Noteworthy! AEM Program Guide Sterilization Resources CMMS Guide Industry Training And much more

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4 Whether dealing with the design, manufacturing, maintenance, or sterile processing of medical devices, AAMI provides you with standards, technical information reports, books, courses, and webinars to: Stay up to date on global regulatory requirements. Implement effective practices. Develop innovative and successful products. We make it easy for you to get the information you need. Contents Industry Training...2 Webinars...3 Certification...5 Annual Conference & Expo...6 esubscription...7 Sterilization...9 Upcoming Standards and Products...12 Dialysis...13 Medical/Health Equipment...15 Quality Systems and Risk Management...17 Healthcare Technology Management...21 AAMI Foundation Resource Catalog

5 EDUCATION: INDUSTRY TRAINING AAMI s education programs are the leading source of industry training for medical device manufacturers. You ll learn about regulatory requirements and standards to help keep your products safe, effective, and in compliance. For complete details and to register, visit Human Factors for Medical Devices Design Control Requirements and Industry Practice Integrating Risk Management into the Quality System Regulatory Requirements for Software Validation The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements Process Validation Requirements and Industry Practice Purchasing Controls and Supply Chain Management Industrial Sterilization for Medical Devices Corrective and Preventive Action Requirements and Industry Practice April 30 May 2, Arlington, VA June 26 28, Manchester, UK September 17 19, Arlington, VA October 15 17, Dublin, Ireland November 5 7, Arlington, VA February 14 16, Arlington, VA March 12 14, Galway, Ireland May 28 30, Dublin, Ireland August 29 31, Arlington, VA September 5 7, Munich, Germany December 5 7, Arlington, VA March 12 14, Arlington, VA November 7 9, Arlington, VA March 19 21, Arlington, VA March 26 30, Arlington, VA April 16 20, Arlington, VA April 30 May 4, Munich, Germany June 18 22, Arlington, VA September 24 28, Arlington, VA October 1 5, Dublin, Ireland December 3 7, Manchester, UK April 18 20, Arlington, VA May 21 23, Dublin, Ireland October 24 25, Arlington, VA April 25 27, Arlington, VA May 21 24, Arlington, VA December 3 6, Manchester, UK June 12 13, Arlington, VA COURSES A Revamped Quality System Course! The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ ISO 13485: Navigating Regulatory Requirements. AAMI was the first to respond to the quality system requirements in 1997 by offering a course. We ve worked with industry experts and FDA representatives to update that course to meet today s fast-changing needs. This intensive 4 ½-day course provides quality system professionals with the information needed to develop and maintain a quality management system that conforms with the FDA s Quality System Regulation (21 CFR 820) and 13485:2016, the international standard that spells out the regulatory requirements for quality management systems. During the course, you ll learn directly from FDA representatives and have the opportunity to interact with them and your colleagues to apply these lessons to your own organization Resource Catalog Order online at or call

6 WEBINARS AAMI's webinars cover a variety of topics and provide an overview of new and revised standards. They are available live and on demand. For complete details and to purchase, visit Upcoming Webinars Consolidating User Interface Design Validation Efforts The Importance of Unique Device Identification for HTM Professionals Writing Human Factors Plans & Reports On-Demand Webinars Applying Novel Sterilization Processes to Healthcare Products Cyber Risk Management for Embedded Medical Devices Cybersecurity for Medical Devices Design Considerations for an Aging Population Designing Safe and Effective Home Healthcare Devices Ensuring Water and Dialysate Quality for Acute Hemodialysis Getting Started with Cybersecurity Risk Management How to Recruit the Best Research Participants Integrating Human Factors into Design Controls: AAMI TIR59 Medical Device Risk Management and Safety Assurance Cases New Tools for Design Control Implementation Preparing for Success: Acute Hemodialysis Survey Readiness Quality System Requirements for Sterile Processing: ST90 Signs and Symbols for Sterile Processing Testing Training: Taking the Training Wheels Off Updates to AAMI s ST79 Steam Sterilization Standard Warnings and Safety Information in Device Labeling Resource Catalog Order online at or call

7 NEW! Updated and Improved The new version of ST79 is a must-have standard for any healthcare facility that uses steam sterilization. Easier to use with reorganized content and color diagrams, it covers every step in the process and can apply to a wide array of facilities where sterile products are reprocessed, stored, and used. New features include guidance on the use of ultrasonic cleaners, new text on following manufacturers instructions, and an annex on alternatives to cooling a sterile processing department (SPD). This best-selling standard is an indispensable tool for any SPD. Use it to help you stay in compliance with accrediting bodies. For complete details and to order, visit Advancing Safety in Health Technology

8 CERTIFICATION As healthcare technology becomes more complex, becoming and staying certified is a way to demonstrate knowledge, skills, and experience in core competencies. Additionally, certifications can demonstrate your ability to provide quality and trustworthy service. Cerftified Biomedical Equipment Technician (CBET) Cerftified Laboratory Equipment Specialist (CLES) Cerftified Radiology Equipment Specialist (CRES) Certified Healthcare Technology Manager (CHTM) Certified Quality Systems Manager (CQSM) CERTIFICATION CALENDAR ACI Certification Exam Registration Deadline ACI Certification Exams ACI Certification Exam Registration Deadline ACI Certification Exams April 13 May 1 15 October 12 November 1 15 Certified Industrial Sterilization Specialist (CISS) Highlight your expertise in the science of sterilization and confirm your understanding of sterilization process development, validation, control, and management as part of the manufacture of healthcare products in one of these areas of specialization: Certified Industrial Sterilization Specialist: Ethylene Oxide (CISS-EO) Certified Industrial Sterilization Specialist: Moist Heat (CISS-MH) Certified Industrial Sterilization Specialist: Radiation (CISS-RAD) For complete details, visit Resource Catalog Order online at or call

9 ANNUAL CONFERENCE Attend the Healthcare Technology Event of the Year! With our knowledge-building educational programming, an Expo Hall of more than 200 medical equipment manufacturers and service providers, and countless opportunities to make new professional contacts, this conference will be your most memorable whether it s your first or 21st! Innovate Come away with new ideas after seeing the latest in medical devices and healthcare technology service in our Expo Hall. Connect Make connections with other professionals in order to share best practices that can help you on the job and improve patient safety. Advance Hear inspiring keynote speakers and learn from industry leaders to gain the knowledge and skills that will help you grow in your career. For complete details and to register, visit Order online at or call Resource Catalog 6

10 esubscription INTERACT WITH YOUR STANDARDS! Whether you need a particular set of standards such as sterilization or a wide range of standards, esubscription makes it easy to access them quickly from anywhere. It s more than a static document. It s an interactive platform in which you can: Have easy access to the latest version. Search within documents and across collections. Bookmark documents, annotate particular sections, and create your own personal library. Add and share comments for organizational collaboration (for enterprise users). Copy sections of standards and create your own personal document. Category Individual Plan Enterprise Plans ANSI/AAMI ST79:2017 This subscription is ideal for individuals, such as consultants. It is only for one user and cannot be transferred. Sterilization in Healthcare Facilities This collection includes 14 sterilization standards and guidance documents, including ANSI/AAMI ST79:2017, ANSI/AAMI ST91:2015, and a new ST79 self-assessment tool. For a complete list of what's included, please visit HTM Collection This compilation includes valuable and practical resources, such as ANSI/AAMI EQ56, the CHTM Study Guide, and the Electrical Safety Manual. For a complete list of what's included, please visit Member: $346 List: $396 Member: $535 List: $749 Member: $635 List: $ Concurrent Users (up to 100 named users) Member: $2,500 / List: $3, Concurrent Users (up to 200 named users) Member: $3,500 / List: $4, Concurrent Users (up to 300 named users) Member: $4,500 / List: $6, Concurrent Users (up to 400 named users) Member: $5,700 / List: $7, Concurrent Users (up to 500 named users) Member: $6,800 / List: $8, Concurrent Users (up to 600 named users) Member: $7,900 / List: $9,000 Access: Generic, Named, IP* 2 5 Concurrent Users (up to 100 named users) Member: $1,950 / List: $2,900 Access: Generic, Named, IP* Resource Catalog Order online at or call

11 Category Individual Plan Enterprise Plans Sterilization Standards Collection This comprehensive collection provides access to all sterilization standards and technical documents for hospitals and healthcare facilities, manufacturers and users of sterilization equipment, and manufacturers who ship sterile products. For a complete list of what's included, please visit Dialysis Collection Includes ANSI/AAMI 13959, ANSI/AAMI 26722, ANSI/AAMI 23500, and TIR58. Human Factors Collection Includes ANSI/AAMI/IEC 62366, ANSI/ AAMI HE75, HE75, TIR49, TIR50, and TIR51. Complete Standards Collection Access more than 200 comprehensive national and international standards and technical documents covering sterilization, dialysis, biological evaluation of medical devices, quality systems, and medical equipment. Updates and new documents are automatically added after their release. *Access Types: Member: $820 List: $1,220 Member: $360 List: $535 Member: $360 List: $535 Member: $1,395 List: $1, Concurrent Users (up to 100 named users) Member: $4,400 / List: $5, Concurrent Users (up to 200 named users) Member: $5,400 / List: $6,750 Access: Generic, Named, IP* 2 5 Concurrent Users (up to 100 named users) Member: $1,950 / List: $2,900 Access: Generic, Named, IP* 2 5 Concurrent Users (up to 100 named users) Member: $1,950 / List: $2,900 Access: Generic, Named, IP* 2 5 Set Users Member: $4,000 / List: $5, Concurrent Users (up to 100 named users) Member: $6,500 / List: $9, Concurrent Users (up to 200 named users) Member: $10,500 / List: $15, Concurrent Users (up to 300 named users) Member: $14,500 / List: $21, Concurrent Users (up to 500 named users) Member: $19,000 / List: $28, Concurrent Users (up to 600 named users) Member $23,500 / List $32,500 Access: Generic, Named, IP* Generic: The organization is provided provided with a link and generic username and password to place on its intranet. Users are required to create their own username and password the first time they access the site. A primary administrator of the site adds users and creates unique usernames and passwords for each user. Named: Users are specific staff who can access the site. This option is best for a single facility or specialized unit. Set users are provided unique usernames and passwords. IP: The organization provides AAMI with an IP address (or range of addresses) along with the company logo. A link is created and provided to the company to place on their internal site. Users are required to create their own username and password the first time they access the site. There is a one-time setup fee of $350. Order online at aami.org/store or call Resource Catalog 8

12 STERILIZATION ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities BEST-SELLING STANDARD! Included within the scope of this standard are functional and physical design criteria for sterilization processing areas (decontamination, preparation, sterilization, and sterile storage areas); staff qualifications, education, and other personnel considerations; processing procedures; installation, care, and maintenance of steam sterilizers; quality control; and quality process improvement. Product Codes: ST79 and ST79-PDF Member: $346 / List: $396 Available as an esubscription for individuals, which is ideal for consultants. This subscription is only for one user and can t be transferred to another individual within the company. See page 7 for details. ANSI/AAMI ST90:2017, Processing of health care products Quality management systems for processing in health care facilities The first standard of its kind for sterile processing departments, ST90 offers a framework for a sustainable, process-driven quality management system. It provides guidance for repeatable results for all device processing areas within a healthcare facility. Product Codes: ST90 and ST90- PDF Member: $122/ List: $214 Available as an esubscription, see page 8 for details. Sterilization in Healthcare Facilities esubscription Available as both an individual and enterprise subscription, this collection includes 14 sterilization standards and guidance documents, including ST8, ST40, ST41, ST58, ST65, ST79, ST90, ST91, TIR11, TIR12, TIR30, TIR34, TIR55, TIR63, and PB70. See page 7 for categories and pricing. ANSI/AAMI ST91:2015, Flexible and semi-rigid endoscope processing in health care facilities FDA-RECOGNIZED STANDARD This standard provides guidelines for precleaning, leak testing, cleaning, packaging, storage, high-level disinfecting, and/or sterilizing of flexible gastrointestinal (GI) endoscopes, flexible bronchoscopes, surgical flexible endoscopes, and semi-rigid operative endoscopes. Product Codes: ST91 and ST91-PDF Member: $135/ List: $229 Available as part of the Sterilization in Healthcare Facilities esubscription. See page 7 for details. Endoscope Reprocessing Video This instructional video covers how endoscopes work, correct handling, reprocessing guidance, and much more. It can be a key resource in promoting patient safety. Product Code: VID-ERCT Member: $128 / List: $213 3 Ways to Order P.O. Box 0211, Annapolis Junction, MD For details, visit Resource Catalog Order online at or call

13 STERILIZATION AAMI TIR29:2012/(R)2017, Guide for process characterization and control in radiation sterilization of medical devices This technical information report provides guidance for characterizing the irradiation process and for establishing requisite process controls to ensure the irradiation system remains in a validated state. This document is intended to complement qualification and routine control activities as defined in ANSI/ AAMI/ISO for gamma, X-ray, and electron beam sterilization. Product Code: TIR29-PDF Member: $122 / List: $214 Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys, 3 rd edition Rose Seavey This publication serves as a guide to healthcare facilities seeking to comply with accrediting body surveys (e.g. CMS, TJC, AAAASF) for the reprocessing of surgical instruments and other reusable medical devices in any healthcare setting. Product Codes: SPHC3 and SPHC3-PDF Member: $140 / List: $240 AAMI TIR12:2010, Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers Product Codes: TIR12 and TIR12-PDF Member: $129/List: $229 ANSI/AAMI/ISO 17664:2017, Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices The provisions of this standard are applicable to medical devices that are intended for invasive or other direct or indirect patient contact. Product Code: PDF Member: $107/ List: $188 Available as an esubscription. See page 7 for details. ANSI/AAMI/ISO 11138, Sterilization of health care products Biological indicators Series ANSI/AAMI/ISO :2017, Part 1: General requirements Part 1 specifies general requirements for the production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes. Product Code: PDF Member: $122 / List: $214 ANSI/AAMI/ISO :2017, Part 2: Biological indicators for ethylene oxide sterilization processes Part 2 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators, and test methods in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas. Product Code: PDF Member: $69 / List: $123 Order online at or call Resource Catalog 10

14 STERILIZATION ANSI/AAMI/ISO :2017, Part 3: Biological indicators for moist heat sterilization processes Part 3 contains the requirements for test organisms, suspensions, inoculated carriers, and biological indicators, as well as test methods intended for use in assessing the performance of sterilization processes employing moist heat. Product Code: PDF Member: $69 / List: $123 Benchmarking Solutions Sterile Processing Compare your sterilization practices to those at similar facilities, make the case for hiring additional staff, and prepare for accreditation surveys. Developed in partnership with IAHCSMM, this tool covers productivity, personnel, budget, and more. Monthly metrics and trend reports provide insights that track improvement. Simplified questions make it easier and faster to get results. Product Code: SPB Member: $750 List: $850 For complete details and to subscribe, visit ANSI/AAMI/ISO :2017, Part 4: Biological indicators for dry heat sterilization processes Part 4 outlines the requirements for test organisms, suspensions, inoculated carriers, and biological indicators, as well as test methods intended for use in assessing the performance of sterilization processes employing dry heat. Product Code: PDF Member: $69 / List: $123 ANSI/AAMI/ISO :2017, Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes Part 5 contains requirements for test organisms, suspensions, inoculated carriers, and biological indicators, as well as test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde. Product Code: PDF Member: $69 / List: $123 Available as part of the Sterilization in Healthcare Facilities esubscription. See page 7 for details. ANSI/AAMI/ISO , Sterilization of health care products Biological indicators Part 7: Guidance for the selection, use and interpretation of results Resource Catalog Order online at or call

15 Upcoming Standards and Products Cardiovascular Data and Device AAMI/ISO 23810, Cardiovascular implants and artificial organs Checklist for preoperative extracorporeal circulation equipment ANSI/AAMI/ISO 5910, Cardiovascular implants and extracorporeal systems Cardiac valve repair devices In store title is: Cardiovascular implants and extracorporeal systems Hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators , Extracorporeal systems for blood purification Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters , Extracorporeal systems for blood purification Part 3: Plasmafilters AAMI SW91, Classification of Defects in Health Software AAMI TIR45, Guidance on the use of agile practices in the development of medical device software AAMI TIR75, Factors to consider when multi-vendor devices interact via an electronic interface AAMI TIR97, Principles for medical device security Post-market security management for device manufacturers AAMI SW2761-1, Medical devices and medical systems Essential safety requirements for equipment comprising the patient-centric integrated clinical environment Part 1: General requirements and conceptual model Dialysis ANSI/AAMI/ISO 23500, Guidance for the preparation and quality management of fluids for haemodialysis and related therapies Part 1: General requirements Part 2: Water treatment equipment for haemodialysis applications and related therapies Part 3: Water for haemodialysis and related therapies Part 4: Concentrates for haemodialysis and related therapies Part 5: Quality of dialysis fluid for haemodialysis and related therapies For a complete list of more than 200 standards, visit and search Product Categories. Order online at or call Resource Catalog 12

16 DIALYSIS Dialysis Standards Collection No dialysis professional, facility, or manufacturer of dialysis equipment or products should be without this complete collection. It includes: ANSI/ AAMI 11663, Quality of dialysis fluid for hemodialysis and related therapies; ANSI/ AAMI 13958, Concentrates for hemodialysis and related therapies; ANSI/AAMI/ISO 13959, Water for hemodialysis and related therapies; ANSI/AAMI 23500, Guidance for the preparation and quality management of fluids for hemodialysis and related therapies, AAMI TIR58, Water testing methodologies; ANSI/AAMI 8637:2010, Cardiovascular implants and extracorporeal systems Hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators; ANSI/AAMI RD47:2008, Reprocessing of hemodialyzers; ANSI/AAMI/ IEC :2012, Medical electrical equipment Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment. Product Codes: DSBK15 and DSBK15-PDF Member: $368 / List: $557 Available as part of the Dialysis esubscription. See page 8 for details. Acute Hemodialysis: Survey Readiness Handbook Jo-Ann B. Maltais, PhD and Glenda M. Payne, MS, RN, CNN This handbook provides a clear explanation of the federal requirements applicable to the acute hemodialysis service and an overview of the expectations for compliance with the standards of the four accreditation organizations that provide quality oversight of hospitals: The Joint Commission, American Osteopathic Association/Healthcare Facilities Accreditation Program, DNV GL Healthcare USA, Inc., and Center for Improvement in Healthcare Quality. Because these accreditation organizations must meet or exceed Centers for Medicare & Medicaid Services (CMS) conditions of participation for hospitals, the authors provide examples on how each CMS standard or condition may be applied in the review of acute hemodialysis services. Product Codes: ACUTE and ACUTE-PDF Member: $140 / List: $240 Dialysis Water and Dialysate Recommendations: A User Guide Edited by Glenda M. Payne This book provides a side-by-side comparison of key regulations and standards. Specifically, it looks at the Centers for Medicare & Medicaid Services (CMS) regulations and interpretive guidance for the Condition of Water and Dialysate Quality and the section related to water and dialysate from the Condition of Care at Home with the suite of ISO standards that have been adopted as replacement for ANSI/AAMI RD52:2004. Product Codes: DUG and DUG-PDF Member: $136 / List: $233 3 Ways to Order P.O. Box 0211 Annapolis Junction, MD For details, visit Resource Catalog Order online at or call

17 MEDICAL/HEALTH EQUIPMENT ANSI/AAMI/IEC , Medical electrical equipment Part 2-30: Particular requirements for basic safety and essential performance of automated type noninvasive sphygmomanometers Product Codes: and PDF Member: $129/ List: $229 ANSI/AAMI/ISO :2010, Small-bore connectors for liquids and gases in healthcare applications This series of standards outlines the design requirements for each connector, specific to its application. Product Codes: or PDF Member: $69/ List: $123 SmartLab Respiratory Analysis Eagle 7301 Eagle 7302 Disposable - Single Patient Use EAGLE SERIES Order online at or call Resource Catalog 14

18 ANSI/AAMI/ISO :2016, Connectors for enteral applications Product Code: PDF Member: $129 / List: $229 ANSI/AAMI/ISO :2016, Connectors for limb cuff inflation applications Product Codes: and PDF Member: $107 / List: $188 ANSI/AAMI/ISO :2016: Connectors for neuraxial applications FDA-RECOGNIZED STANDARD Product Codes: D and D-PDF Member: $129 / List: $229 Parts 3, 5, and 6 are available as esubscription. See page 8 for pricing. ANSI/AAMI ES , General requirement for basic safety and essential performance medical electrical equipment FDA-RECOGNIZED STANDARD This is the American adoption of the IEC standard, which includes U.S. deviations, such as the U.S. national electrical codes. This version contains the rd edition of as well as Amendment 1, which was approved in Following are some of the other U.S. adopted IEC standards. Product Codes: and PDF Member: $596 / List: $ , Medical electrical equipment and systems intended for use in the emergency medical services environment Product Code: PDF Member: $129 / List: $ , Cardiac defibrillators Product Codes: and PDF Member: $129 / List: $ , Infant Incubators Product Codes: A and A-PDF Member: $69/ List: $ , Electrocardiographs Product Codes: and PDF Member:$180/List: $ , Electrocardiographic monitoring equipment Product Codes: Member: $129 / List: $ , Ambulatory Electrocardiographic Systems Product Codes: and PDF Member: $129 / List: $229 Available as an esubscription. See page 8 for details. For a complete list of more than 200 standards, visit and search Product Categories Resource Catalog Order online at or call

19 QUALITY SYSTEMS AND RISK MANAGEMENT AAMI TIR57:2016, Principles for medical device security risk management FDA-RECOGNIZED STANDARD This technical information report provides medical device manufacturers with guidance on developing a cybersecurity risk management process for their products. It blends security and safety risk management by showing how to apply the principles presented in ANSI/AAMI/ISO 14971, Medical Devices Application of risk management to medical devices, to security threats that could impact the confidentiality, integrity, and/or availability of a medical device or information processed by the device. Product Codes: TIR57 and TIR57-PDF Member: $158 / List: $266 Available as an esubscription. See page 8 for details. AAMI/IEC TIR80001, Application of risk management for IT-networks incorporating medical devices FDA-RECOGNIZED STANDARD This set of technical documents provides guidance for managing healthcare IT networks. ANSI/AAMI/IEC TIR :2012, Step-by-step risk management of medical ITnetworks; Practical applications and examples ANSI/AAMI/IEC TIR :2012, Guidance for the disclosure and communication of medical device security needs, risks and controls ANSI/AAMI/IEC TIR :2012, Guidance for wireless networks ANSI/AAMI/IEC TIR :2012, General implementation guidance for healthcare delivery organizations Product Codes: 80001TIRS and 80001TIRS-PDF TIRS: Member:$241/ List: $425 TIRS-PDF: Member: $201/ List: $425 Available as an esubscription. See page 8 for details. The Quality System Compendium: CGMP Requirements and Industry Practice, Third Edition Jack Ward Developed by a team of FDA and AAMI reviewers, this popular resource gives industry professionals clear guidance on 21 CFR Part 820, which deals with current good manufacturing practices for medical devices. The third edition includes new regulations, standards, and guidance documents in a reader-friendly layout. Product Code: QSC3 Member: $390 / List: $650 Order online at or call Resource Catalog 16

20 Writing Human Factors Plans & Reports for Medical Technology Development Michael Wiklund, Laura Birmingham, Stephanie Alpert Larsen This book provides the foundation for developing specific human factors engineering (HFE) work products that are needed to meet the FDA s HFE guidance. The authors have created a fictitious company and product to generate concrete examples of the plans and reports developed during various stages of the HFE process. The book includes an HFE project plan, a formative usability test plan and report, a summative (i.e., validation) usability test plan and report, and an HFE report. These work products and additional content outline the activities necessary to develop safe and effective medical devices, making this book an ideal resource for anyone interested in the medical technology field. Product Codes: HFP and HFP-PDF Member: $125 / List: $175 Premarket Risk Management for New Medical Device Companies Tom Shoup, PhD As a complement to ANSI/AAMI/ISO 14971, this book explains risk management concepts in practical terms to walk you through the creation of a compliant risk management file for a medical device. Your company will benefit from having well-structured evidence of risk management activities necessary to support regulatory submissions, regulatory compliance audits, and compliance testing of the device prior to placing it on the market. The book contains templates for actionable tasks in creating a risk management plan that results in a successful product launch. Product Codes: PRM and PRM-PDF Member: $113 / List: $148 AAMI TIR45:2012, Guidance on the use of agile practices in the development of medical device software FDA-RECOGNIZED STANDARD Agile methodologies have become increasingly accepted in developing software products. This TIR provides recommendations for complying with international standards and U.S. FDA guidance documents. Product Code: TIR45-PDF Member: $135 / List: $229 Available as an esubscription. See page 8 for details. ANSI/AAMI/ISO 14971:2007/(R)2016, Medical devices Application of risk management to medical devices FDA-RECOGNIZED STANDARD This standard specifies a process for manufacturers to identify the hazards associated with medical devices, including in vitro diagnostics to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls throughout all stages of the product life cycle. Product Codes: and PDF Member: $139 / List: $265 Available as an esubscription. See page 8 for details Resource Catalog Order online at or call

21 ANSI/AAMI/ISO 13485:2016, Medical devices Quality management systems Requirements for regulatory purposes Design a quality management system that establishes and maintains the effectiveness of your processes. This standard is meant to be used throughout a device s life cycle, from initial concept through post-production, including final decommission and disposal. It also covers topics such as storage, distribution, installation, and servicing, as well as the provision of associated services. Product Codes: and PDF Member: $135 / List: $229 Available as an esubscription. See page 8 for details. ANSI/AAMI/ISO :2016, Medical devices Recognized essential principles of safety and performance of medical devices Part 1: General essential principles and additional specific essential principles for all non-ivd medical devices and guidance on the selection of standards Product Codes: and PDF ANSI/AAMI/ISO :2017 Medical devices Recognized essential principles of safety and performance of medical devices Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards Product Code: PDF Member: $129 / List: $229 Available as an esubscription. See page 7 for details. Courses The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements Risk Management and Human Factors Additional Quality Systems and Risk Management Resources Integrating Risk Management into the Quality System Free Download 80001: The Business Case for Health IT Risk Management To download your copy, visit 3 Ways to Order P.O. Box 0211, Annapolis Junction, MD For details, visit Order online at or call Resource Catalog 18

22 HEALTHCARE TECHNOLOGY MANAGEMENT AEM Program Guide: Alternative PM for Patient Safety Matthew F. Baretich, PE, PhD This book offers practical guidance on implementing an alternate equipment management (AEM) program and explains how to remain compliant with applicable standards and regulations. Product Codes: AEM and AEM-PDF Member: $60 / List: $93 Computerized Maintenance Management Systems Ted Cohen, MS, FACCE and Matthew F. Baretich, PE, PhD The third edition of this guide offers a foundation for working within a CMMS, which is essential to the success of every HTM department. Product Codes: CMMS and CMMS-PDF Member: $92 / List: $133 ANSI/AAMI EQ56:2013, Recommended practice for a medical equipment management program This recommended practice specifies the minimum criteria for a management program designed to minimize certain risks associated with equipment used during routine patient care. It addresses the structure of the program, documentation, requirements, staffing, and resource allocation. Product Codes: EQ56 and EQ56-PDF Member: $107 / List: $188 Available as part of the HTM esubscription. See page 7 for details. ANSI/AAMI EQ89:2015, Guidance for the use of medical maintenance strategies and procedures This standard identifies and describes various strategies and methods for efficient, effective, and timely maintenance of medical equipment in healthcare facilities. It is intended to help HTM departments standardize and document their maintenance procedures, and provide guidance on selecting the most appropriate maintenance strategy for a given type of device. Product Codes: EQ89 and EQ89-PDF Member: $69 / List: $123 Available as part of the HTM esubscription. See page 7 for details Resource Catalog Order online at or call

23 Get the Most Out of Your CMMS Computerized Maintenance Management Systems for Healthcare Technology Management, 3rd Edition Computerized Maintenance Management Systems for Healthcare Technology Management 3rd Edition In this book, authors Ted Cohen, MS, FACCE, and Matthew Baretich, PE, PhD, provide guidance and best practices for: Proper setup of your CMMS Generating meaningful data Performing better equipment maintenance Ted Cohen, MS, FACCE Matthew F. Baretich, PE, PhD To purchase a print or PDF copy, visit Product Codes: CMMS or CMMS-PDF Advancing Safety in Health Technology

24 Electrical Safety Manual, 2015 Edition Matthew F. Baretich, PE, PhD Revised and expanded, this manual pulls together crucial information from the full range of applicable codes and standards, including ANSI/AAMI ES and the 2012 editions of NFPA 70 and NFPA 99. It includes basic elements that should be contained in an electrical safety program and recommended steps for implementing a costeffective program. Product Codes: ESM4 and ESM4-PDF Member: $131 / List: $216 For a complete list of more than 200 standards, visit and search Product Categories. Submitting a Device to the FDA? HIGHPOWER Labs has been validating reusable medical devices for device manufacturers for 30 years. HIGHPOWER provides a wide range of validation and testing services, as well as consulting to medical device manufacturers and with every major FDA cleared sterilization process in-house, we are available to assist device manufacturers in all of their verification/validation or regulatory compliance needs. Put our services to the test, contact us for a free consultation today. Device Cleaning Sterilization Efficacy Packaging Validation Reusability Testing Biocompatability 125 HIGHPOWER RD, ROCHESTER, NY p: info@highpowervtls.com An ISO Accredited Laboratory Certificate No Resource Catalog Order online at or call

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