Walk into any healthcare facility and ask when they last serviced their medical devices; you are likely to hear the answer, “We do that every year.” In any healthcare facility, performing a service on equipment every twelve months is normal. As such, the idea of having an annual service schedule is so deeply rooted in the minds of facility managers that they believe it to be a legal requirement.
But is it?
The short answer is no. There is no one-size-fits-all medical device calibration schedule. An annual service may be a good default, but a rigid policy of servicing everything every year can lead to over-calibrating simpler, lower-risk devices while potentially overlooking more complex, higher-risk equipment.
At Midwest Biomedical Technologies, our experienced team has been assisting medical institutions with establishing compliant equipment management programs within the Midwest region since 2018. In this guide, we have discussed the factors that dictate medical equipment calibration frequency, established the criteria for assessing inventory, and outlined the relevant regulatory compliance standards.
How Often Should Medical Equipment Be Calibrated?
Medical equipment must be calibrated in accordance with the manufacturer’s recommendations and the clinical risk associated with the device. Even though most manufacturers suggest a yearly calibration, the calibration intervals should be determined based on the equipment’s usage and the environment in which it is kept.
Instead of relying on a generic timeline, healthcare facilities should determine their calibration interval by evaluating:
- Original Equipment Manufacturer (OEM) recommendations
- Applicable federal, state, and accreditation requirements
- The device’s intended clinical use and patient risk
- Measurement accuracy requirements and historical drift
- Frequency of use and environmental wear
What Determines the Right Calibration Interval?
Establishing the calibration interval requires a risk-based approach. According to the National Institute of Standards and Technology (NIST), there is no standard calibration interval because numerous factors should be considered before establishing the calibration interval of an instrument.
Manufacturer Recommendations
The primary consideration for any service schedule can be found in the manufacturer’s service manual. For many categories of equipment, particularly imaging and radiologic devices, federal regulations and accreditation agencies require adherence to the OEM maintenance schedule.
Equipment Risk and Clinical Impact
A device that is used in a critically important procedure or one in which a dosage must be precise to exact measurements poses a greater risk if its reading is inaccurate. High-risk equipment needs to be calibrated more often or more strictly than lower-risk or general equipment.
Usage Frequency and Environment
A patient monitor that is located in a busy emergency room will see more wear and tear as well as use its sensors more frequently than the same device in a less active outpatient setting. The differences in physical, thermal, and mechanical forces can make a significant difference on the lifespan of a piece of equipment
Equipment Age and Historical Drift
As equipment ages, it tends to deviate from the precision of its original state at a quicker pace. By analyzing the equipment history and calibration records, you can determine if a particular piece of aging equipment requires a shortened maintenance schedule to stay within tolerance.
Regulatory and Accreditation Requirements
Joint Commission Organizations as well as CMS permit facilities to make alterations to the maintenance schedules of particular devices through the use of alternate equipment management or AEM. This applies to a variety of devices, but with specific exceptions and with specific requirements to understand what devices require the OEM timeline.
Should All Medical Equipment Be Calibrated on the Same Schedule?
No. Assigning the same service schedule to all of an organization’s devices is not a cost-effective or clinically responsible approach to equipment management. A proper inventory management program will classify devices according to their individual needs and assign service schedules accordingly.
| Equipment Situation | Factors Affecting Frequency | What the Facility Should Consider |
| Frequently used equipment | High physical wear, sensor degradation, rapid historical drift. | Review performance history and usage rates. Consider shortening the interval if out-of-tolerance results occur frequently. |
| High-risk equipment | Severe clinical consequences of inaccurate readings or failure. | Strictly follow applicable requirements and manufacturer guidance. Do not extend intervals without robust, documented justification. |
| Imaging equipment | Strict manufacturer specifications, radiation safety, complex internal components. | Use documented service and verification procedures. CMS guidelines generally prohibit AEM programs for imaging equipment. |
| Newly acquired equipment | Limited historical data regarding stability in your specific facility. | Start strictly with manufacturer guidance. Build an equipment history before considering any schedule adjustments. |
| Equipment after repair | Corrective work, replaced components, or physical trauma may affect measurement baseline. | Perform appropriate post-repair testing and calibration verification before returning the unit to clinical use. |
| Equipment with repeated failures | Evidence of mechanical instability or rapid electronic drift. | Evaluate if the equipment has reached its end of life or if the calibration interval needs to be significantly shortened. |
What Is the Difference Between Calibration, Preventive Maintenance, and Performance Verification?
These terms are often used interchangeably in the context of busy hospitals and clinics, but they have significantly different implications for the biomedical field. Being able to distinguish the two is essential to correctly servicing and recording service completion for compliance purposes.
- Calibration: It can be described as the process of comparing a device’s measurement to a traceable reference standard (i.e., NIST-traceable standards) and adjusting the device so that its measurements are accurate in relation to the standard.
- Performance Verification: It is the process of testing the equipment against set standards to confirm that it is performing within the set parameters without making adjustments to it.
- Preventive Maintenance (PM): A scheduled inspection, cleaning, lubrication, or servicing of equipment or a replacement of batteries or parts in anticipation of future failure and to ensure continued reliability.
- Repair: Actions taken to restore an item that is inoperative, malfunctioning, or nonconforming to technical specifications.
Typically, our biomedical calibration services comprise all three of these steps: we do preventive maintenance, check if everything is working fine, and then calibrate the sensors to guarantee total accuracy.
When Should Medical Equipment Be Checked Before Its Scheduled Calibration?
Even if your equipment has a 12-month service schedule, there are some events that require immediate intervention. Do not wait for the next preventive maintenance if the device went through:
- Physical damage: The device was dropped, hit, or exposed to liquid spills.
- Major repairs: Replacing any of the device’s major internal components (such as sensors, power supplies, or motherboards).
- Unusual readings: Practitioners claim that the results are abnormal for the patient’s condition.
- Relocation: Very sensitive equipment was transported to another facility or subjected to extreme temperatures during transit.
- Repeated alarms: The machine tends to give technical errors or warnings.
How Often Should Imaging Equipment Be Calibrated?
Imaging equipment is one of the most hazardous and highly regulated forms of medical devices. Diagnostic X-ray, computed tomography, fluoroscopy, and ultrasound procedures require proper installation and commissioning to achieve dose accuracy and image quality.
Unlike some general biomedical devices, the maintenance schedule for most imaging equipment cannot be determined by a facility’s preferences. Facilities usually follow the recommendations of the original equipment manufacturer (OEM), state regulations regarding radiation safety, and federal regulations.
At Midwest Biomedical Technologies, imaging is our specialty. Our staff engineer has more than 30 years of experience in radiology and diagnostic imaging. From our office in Oak Brook, Illinois, we provide service imaging equipment support in the region, making sure that your equipment receives the service and testing needed to meet manufacturer guidelines.
What About C-Arm Equipment?
Mobile c-arms are used extensively in the operating room, outpatient surgical centers, and the pain management environment. They undergo frequent movement, being wheeled through doorways and exposed to temperature variations in the OR environment. All this requires careful oversight.
C-arm maintenance comprises more than simply a basic electrical safety inspection. It usually includes a performance evaluation of the image intensifier or flat panel detector, dose checks, mechanical examination, and comprehensive preventive maintenance of the device’s cooling and power supply.
If a system sustains damage, it may require professional C-arm repair. However, testing after repair is a critical step because even a minor maintenance activity can compromise the system’s geometry or output. Thus, facilities should always make sure that systems undergo a comprehensive performance evaluation before being returned to the operating room.
How Should Healthcare Facilities Track Calibration?
If it’s not documented, it didn’t happen. Documentation allows the facility to stay on top of what is going on with their equipment and get ready for state surveys, joint commissions, and internal audits.
A compliant calibration record should capture:
- Equipment identification (Name, OEM, Model, exact Serial Number)
- The particular workshop or department where it was serviced
- The date when it was serviced
- The one who performed the service (name and signature of technician/service provider)
- The test equipment used (including its calibration traceability)
- Particular test results (“as found” and “as left”), pass/fail
- Out-of-tolerance findings with corrective action taken
- The next due date for servicing.
Keeping up with this documentation is a huge task for a busy medical office or rehabilitation facility. That is why many Midwest facilities turn to us for documentation and compliance support to help maintain their equipment histories in an organized and auditable manner.
What Happens If Equipment Fails Calibration?
When a medical device is calibrated or tested and found to be outside of acceptable tolerances, the facility needs to respond accordingly. The general process would be as follows:
- Remove from service: Take the equipment off the clinical floor and put it out of service tag to ensure that it is not used until repairs have been made.
- Documenting the failure: It is important to document the “as found” readings that will give you information on what caused the incident.
- Assessment of impact on patient care: If the device was out of calibration, clinical leadership might have to take actions to determine if patient care had been compromised.
- Perform corrective action: The biomedical technician attempts to adjust the device back into specification. If the first action proves ineffective, medical equipment repair and/or replacement of components are required.
- Verify performance: The repaired unit must be calibrated to verify that it is working correctly.
- Document the return: The final “as left” status is recorded, and the equipment is returned to service.
How Can a Facility Build a Practical Calibration Program?
Building an effective equipment management program means changing the paradigm from a reactive paradigm to a proactive paradigm.
Therefore, the first step is to create a complete digital inventory of the existing equipment: The proverbial knowing what you own. Then, a schedule should be created for every piece of equipment according to the manufacturer’s recommendations or legal requirements.
For many medical offices, skilled nursing facilities, and outpatient clinics, managing this kind of schedule internally can be overwhelming; but partnering with an independent service organization to administer a comprehensive preventative maintenance program is simple!
If you are now considering who to turn to for medical equipment repair, do not forget to read our guide on selecting the best option for your business. This way, you will be able to entrust your diagnostic tools to professionals who will correctly track and treat them, returning them to your staff in good working condition.
Need to Schedule Your Next Service?
Do not worry about keeping up with equipment maintenance requirements for your staff. Regardless of a full facility survey, specific imaging equipment service and repair, or even a regular maintenance program, we are here to help you. Reach out to set up an appointment time to review your inventory and make sure you are always survey-ready.
Frequently Asked Questions
How often should medical equipment be calibrated?
Medical equipment should be calibrated according to the manufacturer’s recommendations, amount of use, and the clinical risk it presents. Typically, equipment is calibrated once a year, but some equipment carries a higher or lower risk or is used more or less frequently, and so is calibrated more often or less often accordingly.
Is annual calibration required for all medical equipment?
No, not all equipment is calibrated annually. That’s a federal standard baseline, but every piece of equipment has a calibration schedule defined by the OEM (Original Equipment Manufacturer), federal regulations, or equipment history. Some are done semi-annually, while others are less frequent.
What determines a medical equipment calibration interval?
The calibration schedule is based on the information retrieved from the manufacturer’s service manual, clinical risk, frequency of use, potential hazards, the instrument’s maintenance history, and relevant regulatory or accreditation requirements (CMS/JCAHO).
Does medical equipment need calibration after repair?
Yes, any device that has been repaired by major corrective maintenance or has undergone component replacement or has suffered trauma shall be verified for performance and accuracy through testing and calibration. This is to ensure that repair did not affect the measurement baseline of the device before returning it to service.
Does Midwest Biomedical Technologies provide calibration services in Illinois and other Midwest states?
Yes. Based in Oak Brook, Illinois, Midwest Biomedical Technologies offers biomedical calibration, preventive maintenance, and repair services to medical institutions in the Midwest of the U.S., including Illinois, Indiana, Wisconsin, Michigan, Iowa, and the surrounding states.