Clinical Engineering

Clinical engineering basics for healthcare systems

Learn clinical engineering basics, including the responsibilities, guiding regulatory standards, and how a Biomed CMMS can help the department.


Medical equipment breakdown in your hospital isn't news. However, the consequences of any equipment failure are usually far-reaching. After an occurrence, you could face anything from inefficiency and downtime to compromised patient care or improper diagnosis. 

A Biomedical (or Clinical) Engineering team helps prevent equipment breakdown. In this comprehensive beginner's guide, you’ll learn more about the following:

  • What is Biomedical Engineering?
  • What are the roles and responsibilities of the Biomedical Engineering department?
  • The difference between Facilities departments and Biomedical Engineering departments.
  • Who defines the regulatory standards for Biomedical Engineering within healthcare?
  • How a Biomed CMMS can help you manage all your clinical engineering department’s needs.

First up, defining Biomedical Engineering.

What is Biomedical Engineering (BME)?

Biomedical (or Clinical) Engineering is the team at healthcare systems primarily responsible for applying and implementing medical technology to optimize healthcare delivery while ensuring cost-effectiveness in hospital equipment maintenance. They ensure medical assets are well maintained, properly configured, and function safely as part of the patient care team. 

Biomedical engineering/equipment technicians (BMETs) may go into patient rooms and help nurses with the operation of medical equipment. They are ultimately driven by patient safety and regulatory compliance. Additionally, they are technology savvy and very good with digital resources.  

At the basic level, a BMET is an equipment manager tasked with providing clinical staff and other end-users with medical equipment knowledge and technologies. 

Roles and responsibilities of the Biomedical Engineering departments

A biomedical engineering technician has a wide variety of responsibilities when it comes to managing equipment. On a day-to-day basis, they:

  • Ensure that all medical assets are optimally functional, well-maintained, safe, and properly configured. 
  • Teach and guide hospital staff on equipment operation, physiological principles, and ensure a safe environment for patients, visitors, and medical personnel. 
  • Install, maintain, configure, inspect, and calibrate biomedical assets and healthcare support systems to ensure that they comply with regulatory guidelines, plus perform other specialized duties and roles, as needed. 

Their responsibilities as patient care team members also include:

  • Operational, technical, and safety resource to clinical staff 
  • Protecting the patients' ePHI (electronic Protected Health Information—usually entered into biomedical assets like X-ray machines and EKGs)

Finally, in managerial or directorial positions, BMETs assume the daily management duties of the department and healthcare technologies. Some of their key responsibilities include:

  • Asset risk assessment
  • Ensuring optimal operational performance
  • Personnel and budgeting management
  • Keeping up with the ever-evolving asset technologies and healthcare trends
  • Ensuring regulatory compliance
  • Capital asset planning, which involves evaluating new equipment for acquisition as well as existing assets for replacement

Healthcare Facility departments vs. Biomedical Engineering departments

The big difference between healthcare Facility departments and Biomedical Engineering departments has to do with work orders and assets. 

Facility departments manage work orders that may include assets, such as HVAC units. On the other hand, BME departments manage assets that may include work orders, such as Preventive Maintenance and Hazard/Recalls. 

Regulatory bodies within Biomedical Engineering 

Like any other healthcare facility department, the Biomedical department is guided by a set of regulatory standards that the stakeholders must comply with. Here's a list of some of the bodies that define and ensure these standards, including a breakdown of what they do:

The Center for Medicare and Medicaid Services (CMS) 

  • Defines regulatory standards required for healthcare

The Joint Commission (TJC)

TJC is a healthcare organization and programs accreditation body tasked with: 

  • Surveying all equipment and departments
  • Identify any compliance issues with the Environment of Care (EOC) standards
  • Inspecting healthcare facilities and reporting to CMS after every three years

Det Norske Veritas (DNV)

DNV is an international accredited registrar and classification society headquartered in Norway. Among other responsibilities, the organization is tasked with:

  • Surveying all equipment and departments
  • Identify any compliance issues with the National Integrated Accreditation for Healthcare Organizations (NIAHO) standards
  • Conducting annual inspections and reporting to CMS after every three years

State Health Department

The state health department exists in every state across the U.S.. It is a public health body involved with licensing healthcare professionals and collecting vital health records, among other roles. In the Biomedical Engineering sector, the body conducts regular surveys and verifies previous surveys. 

College of American Pathologists (CAP)

CAP is a world-leading organization of board-certified pathologists. Beyond that, it serves the public by advocating and fostering best practices in pathology and laboratory medicine. Some of its duties include:

  • Laboratory surveys
  • Performing inspection and reporting to CMC after every three years

Additional Biomedical regulatory influencers:

Other additional known Biomedical regulatory influencers include the following:

  • American National Standards Institute (ANSI)
  • American Society of Healthcare Engineers (ASHE)
  • Association for the Advancement of Medical Instrumentation (AAMI)
  • Emergency Care Research Institute (ECRI)
  • National Fire Protection Association (NFPA)

Support your Clinical Engineering teams with a Biomed CMMS

Hopefully, this guide laying out Biomedical Engineering basics was insightful and you learned more about BMETs and how they help ensure that your hospitals and health systems are always safe for patients, staff, and visitors.

At FSI, we custom-built our CMMS for healthcare maintenance needs. That includes both Facilities and Biomedical Engineering. 

If you’d like to learn more about enterprise asset management and the tools available to help your Biomedical Engineering team, contact FSI for a demo. We provide the best tools to promote safe and efficient hospital operations. With a cloud-based CMMS purpose-built for healthcare professionals, we help empower efficient operations for healthcare systems.  

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