UNIT 1: NEED AND SCOPES OF CLINICAL ENGINEERING

Introduction

Clinical engineering is a specialty within biomedical engineering responsible for the application
of engineering principles and techniques to the healthcare field. Clinical engineers work to
ensure the safety, efficacy, and cost-effectiveness of medical technologies and systems.

1. Definition and Purpose

 Clinical Engineering: A field that focuses on the management and maintenance of

medical equipment and healthcare technology to enhance patient care.
 Purpose: To ensure medical devices and technologies are safe, effective, and used
optimally in clinical settings.

2. Roles and Responsibilities of Clinical Engineers

Clinical engineers play a pivotal role in healthcare, often focusing on areas such as imaging,
biomaterials, therapeutics, and biomechanics. They are responsible for maintaining
documentation of equipment, providing customer support through training, and planning projects
with minimal disruption to services. They also design and implement hospital-wide programs
related to inspection, safety, and maintenance. Their duties may extend to creating technology
assessment reports for new medical instruments and facilitating meetings with medical personnel
to ensure appropriate use of patient care equipment.

Here are examples of responsibilities from real clinical engineer resumes:

 Develop and manage in-house maintenance program utilizing a balance of OEM, third
party, and in-house talent.
 Manage Jenkins security by providing specific access to authorize developers/testers
using project base matrix authorization strategy.
 Direct support of cardiovascular unit, surgery and relate services.
 Support all phases of software development life cycle through FDA approval &
commercial launch.
 Handle complaint reporting, return material authorizations and assure effective timescales
are applied, per the FDA.
 Plan, coordinate and complete each project on schedule and little down time to the
radiology department.
 Design a device for use in keyhole surgery to inject cells or drugs into the wall of the
heart.
 Assist with mandatory CMS documentation education/in-services.
 Provide LabView solutions to data acquisition problems.
 Implement data management procedures compliant with HIPAA regulatory requirements.
  Investigate medical device failures that injure patients and present analysis for root cause
determinations.
 Develop and launch custom LabVIEW base automation programming for use in federal
and pharmaceutical clinical trials.
 Plan and execute software validation and verification procedures for a variety of products
relating to vital signs of patients.
 Support guide wire and balloon dilatation catheter projects, requiring similar activities
associate with development of stent delivery systems.
 Analyze healthcare claims data to develop primary care physician attribution logic and
collaborate with the technology team to implement and validate.

 Equipment Management: Selection, installation, maintenance, and disposal of medical

equipment.
 Technology Assessment: Evaluating new medical technologies for safety, efficacy, and
cost-effectiveness.
 Regulatory Compliance: Ensuring compliance with healthcare regulations and
standards.
 Risk Management: Identifying and mitigating risks associated with medical
technologies.
 Education and Training: Providing training for healthcare staff on the proper use of
medical equipment.

3. Components of a Clinical Engineering Program

 Inventory Management: Keeping detailed records of all medical equipment.

 Preventive Maintenance: Regular servicing and checks to prevent equipment failures.
 Corrective Maintenance: Repairing equipment that has failed or is malfunctioning.
 Quality Assurance: Ensuring all equipment meets required standards.
 Technology Planning: Long-term planning for equipment acquisition and replacement.
 Data Management: Maintaining databases for equipment tracking and performance
monitoring.

4. Need for Clinical Engineering in Hospitals

As healthcare technology rapidly evolves, the landscape is being reshaped by advances in

medical devices, telehealth, personalized medicine, and artificial intelligence. Beyond
information technology, biomedical and clinical engineering professionals stand at the vanguard
of this transformation, applying their unique blend of clinical knowledge and engineering
principles to drive innovation, improve patient care, and ensure the seamless integration of new
technologies into the healthcare ecosystem.

Key Contributions of Biomedical and Clinical Engineers

Biomedical and clinical engineering professionals contribute to healthcare technology in several

critical ways:
 1. Innovation and Design: They are instrumental in designing and developing new
medical devices and technologies that improve patient outcomes. These
professionals, from wearable health monitors to advanced diagnostic tools, bridge the
gap between clinical needs and technological solutions.

2. Integration of Emerging Technologies: They are pivotal in integrating emerging

technologies such as AI, robotics, and nanotechnology into clinical practice.
Understanding the technical and clinical sides ensures these innovations work
seamlessly within the healthcare framework.

3. Maintenance and Compliance: Ensuring that medical equipment is safe, efficient,

and compliant with regulatory standards is another crucial role. This includes regular
maintenance, performance testing, and managing updates or recalls, vital for patient
safety and operational excellence.

 Patient Safety: Ensures that all medical devices are safe and functioning correctly.
 Operational Efficiency: Improves the efficiency of healthcare delivery by minimizing
equipment downtime.
 Cost Control: Helps in managing costs through effective equipment procurement and
maintenance.
 Regulatory Compliance: Ensures compliance with healthcare standards and regulations,
avoiding legal and financial penalties.
 Technological Advancement: Keeps the hospital updated with the latest medical
technology.

5. Scope of Clinical Engineering

Clinical engineering is a specialized field combining medical technology with traditional

engineering methods. Clinical engineers support health care professionals by overseeing the
daily operations of medical tools and equipment.Working with advanced and emerging medical
technologies requires clinical engineers to develop a deeper understanding of different
technological abilities. Since clinical engineers focus on using technology to improve health
care, understanding the basic functions of computer and software programs is an important skill
for professionals in this field. They also use an understanding of computer hardware to complete
designs and install equipment.

 Hospitals and Healthcare Facilities: Primary area of application, involving direct

patient care environments.
 Medical Device Industry: Involvement in the design, development, and testing of
medical devices.
 Government and Regulatory Bodies: Working on policy-making, regulatory
compliance, and public health standards.
 Research and Development: Engaging in research to develop new technologies and
improve existing ones.
 Education and Training: Training healthcare professionals and engineers on medical
technology.
 6. Challenges in Clinical Engineering

Challenge #1: Coordinating service schedules for equipment

Government regulators have strict guidelines about how often and who is qualified to
monitor, test, calibrate, and maintain medical equipment. These activities must be followed
according to manufacturer recommendations, as well as state and federal laws.

Keeping track of the servicing requirements for every piece of equipment can be
an overwhelming task, especially if a biomedical engineer is tasked with maintaining
equipment across multiple facilities. This task is especially challenging because:

 Manufacturers often differ widely in their servicing recommendations

 Clinical staff are often reluctant to part with equipment when servicing is required
 Some products require servicing and preventive maintenance more frequently than others

Challenge #2: Obtaining manufacturer support when problems arise

Equipment often seems to malfunction at the most inopportune times. While some
biomedical engineers have the expertise to diagnose problems and troubleshoot them on the spot,
other engineers may lack enough familiarity with equipment to do this effectively. In these
cases, engineers must contact the manufacturer for support. This process can prove
especially challenging because:

 The equipment has been manufactured in China or another country in a different time zone
 Devices were produced by a manufacturer that is no longer in business
 Manufacturers are unresponsive or slow to respond to urgent requests for technical support

Challenge #3: Locating parts to repair failing equipment

Securing replacement parts for failing equipment is a challenge that all biomedical
engineers face at some point in their careers. However, poor access to replacement parts is
especially difficult for engineers who work in hospitals outside the U.S. that house equipment
that is decades old. Supply chain issues and part availability can slow down procurement, or
even make it impossible. Healthcare providers may be forced to replace equipment, even if it’s
not within their budget.

Challenge #4: Segregating accessories for different equipment makes and models

Life for biomedical engineers would be simpler if manufacturers just designed

products universally compatible with accessories. Unfortunately, many equipment manufacturers
design products that will only accept proprietary parts. As a result, hospital biomeds must
maintain a segregated collection of accessories and parts for every style of monitor, anesthesia
machine and table. Here are a few examples of this type of barrier:

 Many infusion pumps will only accept tubing sets made by a specific manufacturer
 Some monitors require dual lumen blood pressure cuffs while others can only accept single
lumen cuffs
 Some anesthesia machines are built with a selectatec mounting system for vaporizers while
others are built with an auto exclusion style.

Challenge #5: Convincing clinical staff and stakeholders that equipment should be replaced

 Convincing stakeholders that capital equipment needs replacing can be a major challenge unless
the cost to repair a piece of equipment exceeds the costs to replace it. In most cases, biomedical
engineers must prove that a piece of equipment is no longer safe, effective, or functional. In
other instances, hospitals do not have the budget to replace equipment and biomedical engineers
must shoulder the burden of sourcing parts that are nearly impossible to find.

 Rapid Technological Changes: Keeping up with the fast pace of technological

advancements.
 Regulatory Hurdles: Navigating complex regulatory environments.
 Cost Management: Balancing the need for advanced technology with budget constraints.
 Interdisciplinary Collaboration: Working effectively with healthcare professionals,
administrators, and technical staff.

7. Future Trends in Clinical Engineering

 Integration of IT and Medical Technology: Increasing use of IT in medical devices and

systems.
 Telemedicine and Remote Monitoring: Growing importance of remote healthcare
solutions.
 Artificial Intelligence and Machine Learning: Utilizing AI for diagnostics, predictive
maintenance, and data analysis.
 Personalized Medicine: Developing technologies for individualized patient care.
 Sustainability: Focus on environmentally sustainable practices in healthcare technology
management.

Some of the most exciting possibilities of the near future include: Telesurgery, in which
surgical procedures are performed remotely. Tissue engineering for research and
development. Medical virtual reality tools that can create more accurate images and models
of a patient's body.