Clinical Engineering Functions
New medical technologies are becoming available all the time, and clinical engineers are responsible for evaluating these and selecting the most appropriate for their hospital. Sometimes this decision is made after conducting clinical trials. Clinical engineers also either deliver or advise on any additional staff training required for the safe operation of new systems. The role of the Clinical Engineer is becoming ever more closely linked to those of the clinicians delivering care and the scientists making new discoveries for the benefit of healthcare.
What are the core functions of CE professionals in a hospital setting?
- Selecting safe and effective medical equipment
- Maintaining medical equipment and systems
- Improving patient outcomes
- Educating clinical staff
- Controlling costs
Developing, implementing, and directing equipment management programs. Specific tasks include accepting and installing new equipment, establishing preventive maintenance and repair programs, and managing the inventory of medical instrumentation. Issues such as cost-effective use and quality assurance are integral parts of any technology management program. The director advises the administrator of the budgetary, personnel, space, and test equipment requirements necessary to support this equipment management program.
Evaluating and taking appropriate action on incidents attributed to equipment malfunctions or misuse. For example, the clinical engineering director is responsible for summarizing the technological significance of each incident and documenting the findings of the investigation. He or she then submits a report to the appropriate hospital authority and, according to the Safe Medical Devices Act of 1990, to the device manufacturer, the Food and Drug Administration (FDA), or both.
Evaluating and selecting new equipment. The director must be proactive in the evaluation of new requests for capital equipment expenditures, providing hospital administrators and clinical staff with an in depth appraisal of the benefits/ advantages of candidate equipment. Furthermore, the process of technology assessment for all equipment used in the hospital should be an ongoing activity.
Healthcare Facilities Design and Project Management
Assisting in the design of new or renovated clinical facilities that house specific medical technologies. This includes operating rooms, imaging facilities, and radiology treatment centers.
Medical equipment planning
Equipment planning is a vital element in the successful completion of a hospital renovation or new construction project.
Medical equipment planning requires much more than just equipment lists, specifications, and CAD room layouts. Successful healthcare design and construction projects involve the perfect combination of appropriate medical technology consistent with an organization’s strategic vision, technology trends, operational requirements, and patient and staff safety – all while maintaining project budgets. That complex recipe requires effective planning and timely guidance to address those needs.
Healthcare facilities that are designing new patient care areas to accommodate current and future technologies need guidance on budgeting and space constraints, unwieldy construction costs, and rapidly evolving devices and equipment. ECRI Institute
The key to successful design and planning of healthcare construction projects of all sizes involves the incorporation of appropriate medical technology with careful consideration of the following factors:
- The organization’s strategic vision
- Medical technology trends and leading-edge technologies
- Clinical needs and operational requirements
- Patient and staff safety
Establish and deliver instructional modules for clinical engineering staff as well as clinical staff on the operation of medical equipment. In the future, it is anticipated that clinical engineering departments will provide assistance in the application and management of many other technologies that support patient care, including computer support, telecommunications, and facilities operations.
Source: Biomedical Engineering Handbook - J.D.Bronzino - CRC 2000
The clinical engineering personnel have a responsibility to educate not only the next generation of their own kind, but to some extent also their medical colleagues and the consumers of health care. More specifically, these tasks can be described as follows:
- Provision of on-the-job training for engineering personnel who have completed adequate formal education, by the careful development of training schemes with a range of clinical experience and responsibilities,
- Instructional lectures/courses/workshops aimed at providing medical staff, from student to qualified practitioner, with the clearest view of what technology can offer the patient, and
- Where appropriate, advice to consumer representative groups on availability of hardware, effective use of resources and new developments.
These responsibilities require that the clinical engineer keeps up the own level of competency
through continuing education.
Protocol for the Training of Clinical Engineers in Europe, BIOMEDEA , September 2005
Source of Training
- Local schools/Training Centers
- Professional Organizations
- In-house Training Programs
- Develop a training program outlining your needs
- Establish local on the job training program for new employees
Why do we need training?
To ensure proper techniques and procedures are followed in safely manner and best practices for patient care and safety.
Medical Equipment Management Plan
To start managing medical equipment in a hospital, you have to write down the plan to manage and support the medical equipment by writing a Medical Equipment Management Plan (MEMP). What is a MEMP? How it is managed?
The Medical Equipment Management Plan defines the mechanisms for interaction and oversight of the medical equipment used in the diagnosis, treatment, and monitoring of patients. The related policies and procedures govern activities from selection and acquisition to incoming inspection and maintenance of medical equipment. The mission is to ensure that equipment used in patient care is safe, available, accurate, and affordable.
Best practices for such plan include the following key components
- The written plan and its supporting policies and procedures;
- The process for selecting, planning, and acquiring equipment;
- The process for addressing equipment use errors and medical device patient risks;
- Preventive maintenance of life-support and non-life-support equipment and documentation;
- Maintenance strategies and intervals;
- Procedures for responding to alerts and recalls;
- Compliance with standards and regulations requirements; and
- The process for evaluating effectiveness of the management plan and compliance with it.
- Maintenance: Providing comprehensive equipment maintenance, repairs and management services with high customer satisfaction and to expend service on medical equipment.
- Incoming inspection & testing of all purchased, leased, loaned devices on arrival and prior to use. Inspection & Preventive Maintenance (PM) – Determining protocols & frequencies
- Minimizing hazards related to device use, assure that intended users are able to use medical equipment safely and effectively throughout the product life cycle.
- Incident reporting & Investigation
- Providing a safe environment with high customer service.
- Encouraging and assisting department members to develop their knowledge and increase their competence in the area of medical equipment troubleshooting, repair and maintenance with emphasis on high quality maximum patient safety and cost effectiveness.
- Expanding the knowledge of members of specific tools and techniques used in clinical/biomedical engineering and other related fields.
- Encouraging and assisting by conducting, participating in regular meetings, conferences and educational programs.
- Providing a medium for the interchange of ideas among members and dissemination of information to members.
- Introduction of a student member to the profession of clinical/biomedical engineering, and the social role and obligations of the CE and BMET.
- Preparation of student members to enter into the profession of clinical/biomedical engineering.
- User Education: Providing in-service training to department and hospital staff, as and when required.
- Safety Alert/recall: Receive and distribute equipment hazard alerts and recalls when and as applicable. Coordinates hazard recall notices for equipment and disposables provided by manufacturers, distributors, ECRI , FDA and local authority.
- Cooperation: Technical and Staff Supports to Primary Health Care Biomedical department as and when required.
- Home Healthcare: Home Health Care equipment support, maintenance and user training.
- Coordination: Liaising with the logistics and user department for the identification of replacement parts and consumables for all medical equipment.
- Contract Management: manage, review and oversee equipment service and maintenance contract and compose recommendations.
- Technical Consultation: Provides technical advice on specifications, pre-purchase evaluations and equipment selection, assisting end-users acquiring new medical equipment.
- Technical Assessment: Provide technical assessment for on loan, trail and demonstration medical equipment for medical/clinical departments.
- Undergraduate Training: Provide Biomedical long and short term Trainings for interns and biomedical students from universities.
- Budget Preparation: Prepare and responsible for department budget yearly.
- Performs other tasks and assignments as per the organization needs and directive.
- Committees: Participating in different hospital Committees as and when required such as but not limited to:
- Patient Safety Committee
- Hospital Safety Committee
- Capital Medical Equipment Committee
- Infection Control Committee
- Emergency Preparedness Committee
- Multidisciplinary Environmental Rounds
- Projects Committee
Medical Equipment Maintenance
What is maintenance?
The combination of all technical and administrative actions, including supervision actions, intended to retain an item in, or restore it to, a state in which it can perform a required function.[British Standard Glossary of terms (3811:1993)]
Defined also as activities required or undertaken to conserve as nearly, and as long, as possible the original condition of an asset or resource while compensating for normal wear and tear.
Clinical Engineering Department (CED) provide comprehensive equipment maintenance, repairs and management services with high customer satisfaction and to expend service on medical equipment.
Types of Maintenance
This is maintenance that you do on a regular basis, which helps keep things in working order. “Schedule of planned maintenance actions aimed at the prevention of breakdowns and failures” Primary goal-Preserve and enhance equipment reliability. It is a set of activities that are performed on plant equipment, machinery, and systems before the occurrence of a failure in order to protect them and to prevent or eliminate any degradation in their operating conditions.
The maintenance carried out at predetermined intervals or according to prescribed criteria and intended to reduce the probability of failure or the degradation of the functioning and the effects limited. [British Standard Glossary of terms (3811:1993)]
Why do we need a PM program?
The PM will include but not limited to the following benefits:
- Increases life of equipment
- Reduces failures and breakdowns
- Reduces costly downtime
- Decreases cost of replacement
- Allows for money to be budgeted for repairs
- Lowers need for extensive parts inventory
The factors that affect the efficiency of this type of maintenance
- The need for an adequate number of staff in the maintenance department in order to perform this type of maintenance.
- The right choice of production equipment and machinery that is suitable for the working environment and that can tolerate the workload of this environment.
- The required staff qualifications and skills, which can be gained through training.
- The support and commitment from executive management to the PM program.
- The proper planning and scheduling of PM program.
- The ability to properly apply the PM program.
PM Procedures Manual
The preventive maintenance procedure manual should include all medical equipment in the CMMS system as per the department categorizations of what on the PM schedule. The PM procedures should be initiated on the time of receiving the new equipment for inspection. The PM procedure should follow according to the organization policy, manufactures recommendation and CES maintenance history and experience with similar equipment. That is followed with the risk assessment by the biomedical equipment technician (BMET) at time of inspection. All necessary parts, tools and test gears should be noted as well. It depends on the CES program whether such PM procedure entered into the CMMS system as digital copy and attached with the PM work order or hard copy on manual file within the workplace.
Corrective Maintenance (CM)
In this type, actions such as repair, replacement, or restore will be carried out after the occurrence of a failure in order to eliminate the source of this failure or reduce the frequency of its occurrence.
The maintenance carried out after recognition and intended to put an item into a state in which it can perform a required function. [British Standard Glossary of terms (3811:1993)]
The difference between corrective maintenance and preventive maintenance is that for the corrective maintenance, the failure should occur before any corrective action is taken.
There are two categories in CED with regard to medical equipment types
First category: the equipment in this category is specialized, sophisticated and of high capital cost. It is commonly maintained under comprehensive and/or demand maintenance contract agreements, by the manufacturer/agent. It is the responsibility of the CED to monitor and supervise all of the contracts under its jurisdiction and ensure the maintenance is carried out in a timely and technically competent manner and to a high standard. These contracts include the maintenance of imaging equipment, radiation equipment, dialysis water analysis, etc…
Second category: the equipment in this category includes all electronic and mechanical medical equipment from patient monitors to patient ventilators and from laboratory analyzers to renal dialysis machines. It also includes surgical instruments, operating tables, and intensive care beds. A very high percentage of these equipment are maintained in-house. Part of this category is maintained –in case of breakdowns- by the local agents as and when required.
How we can achieve a best practice of maintenance
This is achieved through a mix of in-house maintenance and services purchased from supplying companies and/or third party services.
Models for Service Delivery
There are two types of services delivery models are available which are:
- Centralized (dispatch or depot)
- Less duplication,
- Easier management
- Better response time (therefore less downtime)
- Generally less efficient use of resources (more costly)
- Nature (method) & quality of communications
- Geography of service area (i.e., travel distances)
- Nature (method) & quality of transportation available
- Response time necessary
- Use resident or in-house services for “basics” for category one, and
- Use centralized or Independent Service Organization (ISO) services for more technically specialized needs for the second category
Computerized Maintenance Management System (CMMS)
indicators requires the collection, storage, and analysis of data from which
the indicators can be derived. Many Computerized Maintenance Management Systems
(CMMS) are handy available to determine the most common data elements used.
Indeed, most of the high-end software systems have more data elements than many
clinical engineering departments are willing to collect. This is especially
important if the data will later be used for comparisons with other
organizations. Different departments often have different definitions for the
same data element. It is crucial that the data collected be accurate and
complete. It makes no conceptual difference if the database is maintained on
paper or using computers. Computers and their databases are ubiquitous and so
much easier to use that usually more data elements are collected when
computerized systems are used.
The clinical engineering department must consistently gather and enter data into the database. The database becomes the practical definition of the services and work performed by the department. This standardized database allows rapid, retrospective analysis of the data to determine specific indicators identifying problems and assist in developing solutions for implementation. A minimum database should allow the gathering and storage of the following data:
- In-House Labor.
- Vendor Labor.
- Spare Parts.
- Problem Identification.
- Equipment Identification.
- Service Requester.
- Full (comprehensive) service contract that include labor and parts coverage during working hours. You may include the coverage to be 24x7 at different agreement if and when required.
- Service contract which is similar to above but no parts included in the contract.
- Preventive Maintenance (PM) Only - this type of contract does not cover unplanned corrective maintenance but you may agree with the contractor to provide a limited service call on emergencies only.
- Demand service contract - Arrangement in which a contractor is paid on the basis of actual cost of direct labor, usually at specified hourly rates and the actual cost of parts used.
- Shared service contract that include training of your staff by the vendor/manufacture to be the first responder for any service calls and vendor's engineers follows up as and when required.
When determining type of cover it is vital that an assessment is carried to determine amount of usage and reliability of the equipment. This should be carried out by looking at historical information held on the equipment database to determine number of breakdowns, and reasons for those breakdowns. If the equipment has been in use for 12 months, with no call-outs to the service supplier, it may be more cost effective to wait until the equipment breaks down, rather than build in maintenance cover that will not be used. Comprehensive contracts are expensive, and it can be more cost effective to call out the service supplier on demand basis for repairs and have a planned maintenance contract for routine maintenance.