Biomedical Maintenance Services: Benefits and Considerations

In today’s healthcare environment high-tech equipment is center stage. Advanced medical equipment is integral to accurate diagnoses, effective treatment, and critical lifesaving. That biomedical equipment needs to be in optimal working order at all times is a nonnegotiable point. It is here that biomedical equipment services become an important player on the field of healthcare.

Biomedical services not only ensure that medical equipment is in proper working order, but they help healthcare facilities,

• operate efficiently,
• maintain compliance with regulations, and
• stay on the front lines of advancement in medical technology.

This article will explore the benefits of annual biomedical services for maintaining biomedical equipment and why these services are critical to quality of care and patient safety.

We will explore:

• Understanding Biomedical Maintenance Services
• Benefits of Biomedical Maintenance Services
• Considerations When Choosing Biomedical Maintenance Services
• Biomedical Maintenance Services FAQs

Understanding Biomedical Maintenance Services

Regardless of how technologically advanced medical equipment is, at some point it will require maintenance to continue functioning at peak performance.

Biomedical equipment maintenance in the form of calibration, repair, and inspection is performed by professional biomedical technicians on a wide range of medical equipment and devices. The following is a list of common categories of medical equipment requiring biomedical services.

• Computer Equipment
• Dermatology
• Diagnostic Testing
• Emergency Response
• ENT
• Imaging Equipment
• Laboratory Equipment
• Life Support Equipment
• Medical Gas Systems
• Ophthalmic
• Patient Monitoring Equipment
• Rehabilitation Equipment
• Surgical Equipment
• Therapeutic Equipment

As evidenced by the wide array of medical equipment categories presented, never mind the innumerable varieties of equipment and devices within each category, healthcare facilities would face significant challenges delivering high-quality care without biomedical maintenance services.

Benefits of Biomedical Maintenance Services

Although obvious, it bears saying that the proper maintenance and servicing of biomedical equipment and devices is essential to ensuring accurate diagnoses, effective treatments, and quality healthcare.

Equipment Reliability

Biomedical equipment should receive scheduled calibration and maintenance to ensure reliable performance. Regular biomedical services identify worn or broken components that should be replaced to keep equipment operating at peak efficiency or to prevent a complete equipment failure. Reliable biomedical medical equipment contributes to efficiency and cost containment by mitigating the downtime associated with improperly performing medical equipment and devices.

Optimal Performance and Accuracy

The same scheduled biomedical equipment maintenance that ensures reliability also ensures optimal performance and accuracy in medical equipment and devices. Regularly cleaning, calibrating, and fine-tuning equipment keeps it operating at optimal levels. It follows that medical equipment operating at peak performance returns accurate data.

The data generated by medical equipment is used by healthcare professionals to make clinical decisions, some of them lifesaving. Whether used to make a diagnosis or recommend treatment, the integrity of medical data is critically important.

Extended Equipment Lifespan

Medical equipment that receives regular biomedical maintenance services often lasts longer than medical equipment that is not maintained. During routine or preventative maintenance, medical equipment is cleaned, preventing corrosion damage. Additionally, worn or damaged parts are replaced, before they cause more costly damage or complete equipment failure.

With the cost of new medical equipment continuing to escalate, healthcare facilities are coming to rely more on scheduled preventative maintenance and calibration to extend the life of medical equipment rather than seeking to replace it.

Cost Savings and Efficiency

Annual preventative maintenance conducted by biomedical services technicians also offers the benefit of helping healthcare facilities control costs in an environment plagued by staff shortages and growing financial challenges.

Unreliable or failing biomedical equipment can result in disruption to patient care and efficiency. Not only does poorly performing equipment impact efficiency, but equipment downtime also carries a significant cost to the healthcare facility. For example, the coat of downtime for a hospital EHR is $5,300-9,000 per MINUTE. ¹

With scheduled maintenance of biomedical equipment potential problems with the equipment may be identified and can be addressed before they become bona fide issues that cause downtime. In short, downtime can be mitigated if not prevented entirely, ultimately saving the facility time and money.

Considerations When Choosing Biomedical Maintenance Services

As with all things of importance, careful consideration should be given to choosing biomedical maintenance services. Not only do these services ensure the reliability and integrity of medical equipment, but they also contribute to patient safety and positive outcomes. At the risk of being melodramatic, choosing the proper biomedical maintenance services provider could save a life.

When vetting biomedical services providers consider the expertise of the technicians and their familiarity with regulatory compliance standards. Does the provider maintain inspection documentation and reporting on behalf of the facility? Are services flexible enough to accommodate a facility’s unique needs or schedules?

Expertise and Qualifications

Biomedical Engineering Technicians (BMET) should be BMET certified. This means that the technician holds at least an associate degree in biomedical engineering, has two years’ work experience, and has passed the certification exam. Exams must be administered by recognized organizations such as the International Certification Commission for Biomedical Equipment Technicians (ICC-BET).

There are in fact a variety of BMET certifications, including equipment specialization, in addition to the basic certification. Here are the top ten.

• Certified Biomedical Equipment Technician (CBET)
• Certified Clinical Engineering Technologist (CCET)
• Certified Medical Equipment Technician (CMET)
• Certified Healthcare Technology Manager (CHTM)
• Certified Radiology Equipment Specialist (CRES)
• Registered Medical Instrument Technician (RMIT)
• Certified Laboratory Equipment Technician (CLEC)
• American Society for Clinical Pathology Certification in Medical Laboratory Technology (ASCP-MLT)
• National Institute for Certification in Engineering Technologies Biomedical Electronics Technician (NICET-BETC)
• Association for the Advancement of Medical Instrumentation Biomedical Equipment Technician Certification Program (AAMI-BMETCP)

Service Customization

Biomedical services plans or contracts generally include scheduled “check-ins”, annual routine maintenance, performance checks, and compliance inspections. There may be clauses related to repair services and warranties on work performed.

In addition to the preventative maintenance contract custom services such as asset-tagging, staffing solutions, and asset validation services may also be included in the services agreement.

Documentation and Reporting

Following biomedical maintenance of performance testing, safety inspections, and equipment or device specific verifications the findings and data are recorded in logs kept by the healthcare facility. For example, autoclaves are commonly tested and inspected by BMETs. Data from the biomedical and chemical indicators testing, performance check, electrical safety inspection, and temperature verification on tabletop autoclaves is recorded in logs.

This documentation is required to prove compliance with regulatory standards. Entries must include the ID of the equipment or device inspected, inspection frequency, inspection procedure, testing findings, and the biomedical technician conducting the testing or inspection.

Additionally, many healthcare facilities maintain repair records. These records are integral to the decision-making process around continuing to repair or decommissioning and replacing the equipment.

Regulatory Compliance and Standards

Biomedical equipment maintenance in the form of annual testing is required by the government and hospital industry on all new, used, or reconditioned medical equipment in use in hospitals, surgery centers, clinics, and medical practices.

Several organizations set compliance regulations for biomedical equipment manufacture and maintenance. These regulations are in place to ensure the reliability and accuracy of medical equipment and devices. Patient safety and positive outcomes are the natural extension of reliable medical equipment.

Food and Drug administration

The U.S. Food and Drug Administration (FDA) has established regulations to assure that medical equipment and devices are safe and effective throughout their total product lifecycle. FDA regulations govern the manufacture of high-quality medical devices through to the proper maintenance and servicing of medical devices. Safe, effective, and reliable performance of equipment and devices used in healthcare is always a top priority.

FDA regulations are not optional. The FDA can enforce regulatory compliance through injunctions, warning letters, and administrative procedures.

Association for the Advancement of Medical Instrumentation

The Association for the Advancement of Medical Instrumentation (AAMI) is a non-profit organization established to “advance the development, and safe and effective use of medical technology.” ^2.

The American Standards Institute (ANSI) has accredited AAMI as a standards development organization.

Some sample standards advanced by AAMI include:

• ANSI/AAMI ST79 – guidance for steam sterilization
• ANSI/AAMI ST91 2021 – sterilization guidelines for endoscopes
• ANSI/AAMI ST98 - validation of manufacturers cleaning processes for processing medical devices
• ANSI/AAMI ST108 - guidance on water quality for device reprocessing.
• ANSI/AAMI PB70:2022 – classification system for protective apparel

Adherence to these and other AAMI standards is a voluntary action by healthcare facilities.

International Organization for Standardization (ISO)

ISO standards are an internationally agreed upon way of doing something. They are voluntary. According to ISO “standards are the distilled wisdom of people with expertise in their subject matter and who know the needs of the organization they represent. “³

For biomedical equipment manufacturers adherence to ISO Quality Management Standards is in many ways an indicator of quality products. The recognizable 9001 standard is the only quality management standard that can be certified. The most applied standards for medical devices are 14971, 10993, 62304, and 13485.

• ISO 14971:2019 – application of risk management to medical devices
• ISO 10993:2018 – define standards for evaluating the biocompatibility of medical devices to manage biological risk.
• ISO 62304:2006 – defines the life cycle requirements for medical device software.
• ISO 13485:2016 - specifies requirements for a quality management system for the design and production of medical devices.

Environmental Management Standards are being increasingly applied to manufacturing and healthcare facilities commit to more sustainable practices.

The Joint Commission

The Joint Commission (TJC) is the oldest standards-setting and accreditation body for medical facilities in the United States. TJC is not a government agency and accreditation by the Joint Commission is not required by law. However, facilities accredited by TJC may enjoy better liability insurance terms and higher payments by medical insurance companies.

Accreditation by TJC demonstrates compliance and commitment to patient safety and is viewed as a means of improving the reputation of the healthcare facility. Joint commission standards are stringent and hold healthcare organizations accountable for health-related outcomes.

To become and remain TJC accredited, facilities are reviewed by the Joint Commission then every two to three years the commission conducts unannounced weeklong reviews. Healthcare facilities must continuously prepare for a Joint Commission visit.

Liability insurance and support from the state and federal government as Medicare and Medicaid payors can be contingent on TJC certification.

Whether ensuring compliance with federal regulations or seeking to improve the reputation of the facility with voluntary certifications and accreditation, biomedical equipment maintenance and biomedical equipment services are universally essential across the healthcare landscape.

Concluding Thoughts

Preventing equipment failures with annual biomedical service to medical equipment minimizes the safety and treatment disruption risks to patients. In the arena of treatment disruption risks associated with equipment failure one would only need to imagine an ER with a malfunctioning defibrillator to understand the need for preventing equipment failure.

Regulatory compliance and standards are in place to help prevent medical equipment failure. However, very often hospital staff are not trained, nor do they have the proper time needed to inspect equipment and devices for compliance.

Biomedical equipment service technicians are trained not only to maintain and repair biomedical equipment but also to inspect the equipment for compliance. Compliant biomedical equipment is far less likely to fail.

CME Corp. Biomedical Maintenance Services

CME is not only a premier high-tech medical equipment distributor but also a reliable source for biomedical services.

Inspecting and testing new equipment can drain the resources of a healthcare facility’s biomed team and delay the facility opening, costing valuable time and revenue.

CME Biomedical Equipment Technicians are available to compliment in-house resources during large projects or a period of biomedical staffing deficit.

For example, during a recent project in Colorado the CME Biomedical Services team:

• Performed 1,729 incoming inspections,
• Placed 461 capital tags,
• Conducted 575 Safety Inspections, and
• Clocked 300 technician hours.

Biomedical services have been at the heart of CME for over 35 years. With this expert experience we are ready to support your biomed team to ensure your facility opens on time and is fully functional.

Here’s how:

• Initial pre-project meeting with your biomed staff to discuss hospital requirements for incoming electrical inspections.
• Deliver, de-box, assemble, and install all equipment and remove trash.
• Document any failed equipment with hospital and manufacturer at time of receiving.
• Inventory and catalog all items by Asset ID#, Manufacturer, Model, SN, and location.
• Perform comprehensive equipment testing for electrical safety.
• Additional testing may include equipment functionality, battery functionality, scale calibration, preventative maintenance, performance verification, and output measurement testing.
• Affix asset ID tags and inspection result stickers according to hospital guidelines if needed.
• Provide all required documentation and equipment reporting for your CMMS.

CME start up biomed services guarantee that every device is tested and ready for service.

Our BMETs can also work with your facility to establish equipment maintenance plans aimed at ensuring the reliability of medical equipment and compliance with regulations.

Click the CHAT button to start a conversation about your BMET needs.

Biomedical Maintenance Services FAQs

What is a biomedical inspector?

Biomedical inspectors perform biomedical maintenance services. During maintenance biomedical technicians inspect the physical condition of equipment for worn or damaged features as well as conduct performance testing.

What kind of biomedical equipment typically requires the most maintenance and repairs?

How often biomedical equipment needs to be repaired can be correlated to how frequently the equipment receives scheduled preventative maintenance. All biomedical equipment should receive annual preventative maintenance.

What is biomedical equipment?

Biomedical equipment is any device or instrument used in the fields of healthcare, pharmacology, or biology. In healthcare these devices are used to diagnose and/or treat patients.

What do biomedical diagnostics do?

Biomedical diagnostics provide information that helps diagnose diseases and health conditions such as cancer, cardiovascular issues, diabetes, and infectious diseases.

About CME: With two corporate offices and 35+ service centers, CME Corp is the nation’s only equipment focused medical equipment distributer. We are the premier source for more than 2 million healthcare equipment products, from more than 2,000 manufacturers.

Our Turnkey logistics and biomedical services allow us to help healthcare facilities nationwide reduce the cost of the equipment they purchase, make their equipment selection, and schedule delivery, installation, and maintenance without impacting patient care. From medical equipment purchases to renovations and new facility construction CME Corp is your partner for seamless capital medical equipment purchases, delivered on time and in budget.