Course Content:

This 6-module virtual course engages those interested in entering the Healthcare Technology Management (HTM) field with expert developed content, interactive practice tools, and pre/post-assessments designed to unpack the requisite focus areas of the field. The areas covered in this course align with those tested in the AAMI Certified Associate in Biomedical Technology (CABT) program.

BMET 101 is geared towards individuals who have limited to no experience in HTM and are in need of an entry-level overview of the field. Employers can also implement this eLearning product as a way to onboard new hires with a base level training as they begin their BMET role.

Course Modules:

About A BMET

• Explore a basic overview of the roles and responsibilities Biomedical Equipment Technicians typically fill and learn exactly what it takes to become a BMET.

Safety

• Participants will learn to 1) identify basic infection control measures and personal protective equipment, 2) describe hazardous material safety data sheets, 3) explain Lock Out Tag Out (LOTO), 4) Identify safety symbols (e.g., color coding for gases, signage), and 5) identify the safety risks associated with various medical equipment (e.g., imaging devices, defibrillator, lab equipment).

Regulatory

• This lesson will explain BMETs impact on patient safety and which regulatory agencies set guidelines.

Electronics

• Participants will learn to 1) solve basic circuit problems involving DC and AC circuits, 2) utilize basic electronics terminology (e.g., electrostatic discharge (ESD), wiring, color-code wire standards, ground, voltage, current, resistance, LED), 3) describe Ohm’s Law and how it applies to electrical safety and testing, and 4) recognize basic concepts of electricity and symbols (e.g., fuses, circuit breakers, capacitors, batteries, transformers).

Anatomy & Physiology

• Participants will learn how to explain the structure and function of the major organ systems in the human body, including the cardiovascular, nervous, endocrine, muscular/skeletal, respiratory, digestive, and renal systems.

Medical Devices

• Participants will learn to 1) Identify the different areas of the hospital, 2) differentiate between diagnostic, monitoring, and therapeutic equipment, 3) identify the different areas of the hospital and the types of medical equipment you will find in each area, and 4) Describe the basic theory of operation, functioning and clinical application of medical devices (e.g. heart monitors, EKG carts, bladder scanners, defibrillators, ventilators, blood pressure monitors, pulse oximeters, infusion pumps [IV, PCA, feeding], suction devices, electrical surgical units, and centrifuges and carry out operational checks on such devices

FDA’s adoption of ISO 13485 in its Quality Management System Regulation (QMSR) harmonizes quality systems globally for medical devices. AAMI is pleased to support the transition with our new Clause-by-Clause: ISO 13485 eLearning tool. This online course examines each ISO 13485 clause to ensure you fully understand the Standard’s implications and requirements. The Clause-by-Clause approach with video instruction by top industry leaders allows you to progress at your own pace. Iterative self-assessment tools strengthen your knowledge and detect and correct misunderstandings.

The Benefits:

1. Stay Ahead of Compliance Requirements: With two years to modify quality systems to meet QMSR and ISO 13485 requirements, our eLearning tool equips you with the knowledge and skills needed to stay ahead of compliance deadlines and navigate regulatory changes.
2. Practical Application: Explore how each clause drives quality in real-world scenarios, utilizing insights from industry professionals and FDA experts.
3. Problem-Solving Strategies: Identify and address common challenges encountered in clause implementation, enhancing preparedness and helping your organization overcome hurdles and ensure a smooth transition.
4. Benchmark for Excellence: Learn best practices associated with each clause, illustrating what excellence in compliance looks like and guiding organizations toward high-performance quality management systems.

This learning assessment tool provides a thorough examination of ISO 14971, aiming to enhance participants’ understanding of each clause and its practical implications for identifying, evaluating, and controlling the risks associated with medical devices throughout their lifecycle. The assessment is designed to explore how each clause contributes to driving excellence in practice, offering insights into the tools, procedures, and documentation commonly employed by the industry to meet these requirements.

Learners in this training will be able to:

• Articulate how each clause influences and promotes quality within the medical device lifecycle.
• Provide practical examples of how adherence to the clause enhances the overall quality of the development, manufacturing, and post-market processes.
• Identify the industry-standard tools and procedures utilized to address the specific requirements outlined in each clause.
• Highlight the key documentation and artifacts produced during the implementation of these tools and procedures.
• Explore the challenges faced by the industry in effectively implementing each clause.
• Analyze potential pitfalls and risks associated with non-compliance or incomplete adherence to the specified requirements.
• Offer insights into best practices for successful implementation of each clause.
• Define the characteristics of an exemplary, “great” implementation, showcasing examples from industry leaders.

This learning assessment tool provides a comprehensive view of ISO 14971, going beyond theoretical knowledge to emphasize the practical implications and real-world applications of each clause. By delving into the industry’s experiences, challenges, and best practices, participants gain a holistic understanding of the standard’s impact on driving quality in the medical device sector while mitigating risk.

This updated and improved self-paced online course allows you to navigate the content areas of the CBET exam via an interactive, comprehensive modular eLearning experience. Each of the modules begins with a knowledge assessment of 10-15 questions and ends with a practice exam of 30 questions. This gives learners an idea of how much time/effort they may need to allocate to each module.

This eight-session course covers each of the Certified Biomedical Equipment Technician exam’s topic area, including

• Anatomy and physiology
• Public safety in the healthcare facility
• Fundamentals of electricity and electronics
• Healthcare technology and function
• Healthcare technology problem-solving
• Healthcare information technology