The Importance of Quality Assurance in Refurbished Medical Equipment

March 28, 2025

In healthcare, medical equipment is essential for optimal patient care, from diagnostics to critical life-saving procedures. The performance and reliability of these devices are non-negotiable, as lives depend on them. Whether new or refurbished, medical equipment must function flawlessly, as intended by the original manufacturer (OEM). This highlights the crucial role that quality assurance plays, particularly in refurbished medical equipment, where attention to detail is essential.

A Gap in Refurbishment Standards

Unlike new medical devices, where FDA regulations dictate performance standards, no formal guidelines govern the refurbishment process. This lack of regulation means that the quality of refurbished equipment can significantly differ between providers. It also places the responsibility on decision-makers to research and ensure they purchase from a reputable company. Creating a comprehensive refurbishment process that meets high standards is essential to assure that refurbished equipment is reliable and safe for patients. Without a standardized process, refurbishing companies may adopt different methods, some of which may not fully restore the equipment to its original condition. This variability introduces risks to patient safety and complicates clinical workflows. Healthcare providers should choose partners who adhere to comprehensive quality assurance protocols that make sure refurbished devices meet the same performance standards as new equipment.

Why Does Quality Assurance Matter?

The stakes are high when it comes to medical equipment performance. A failure in a clinical setting could have tragic, even fatal, consequences. Quality assurance isn’t just important; it’s essential. A comprehensive refurbishment process guarantees that equipment performs as well as it did when it first left the OEM. This gives healthcare providers confidence that refurbished devices will deliver safe and effective patient care. Quality assurance in refurbished medical equipment goes beyond simply ensuring that the device powers on. It includes thoroughly assessing the equipment’s functionality, safety features, and reliability. For example, ventilators and anesthesia machines are life-support systems in critical care environments. Refurbishment should extend beyond powering the unit on and performing a ventilation check. A thorough process should also involve measuring the volume and pressure accuracy of gases, checking the gas mixture, ensuring that backup systems work in case of failure, and verifying that anesthetic gases are not exposed to healthcare staff. Additionally, inspections are necessary to identify parts on the verge of failure, which might not always be visible through standard OEM preventive maintenance procedures. The refurbishment should also restore the device’s original cosmetic appearance, avoiding contamination during the process, and undergo a re-check to ensure that performance parameters are retained. After this process, the system should easily pass the Biomedical pre-check in an operating room. A comprehensive quality assurance process simulates real-world usage to ensure the equipment is patient-ready.

The ISO 13485:2016 Certification

ISO 13485:2016 is an internationally recognized certification demonstrating a medical equipment company’s commitment to stringent quality management standards. Achieving and maintaining this certification is a rigorous process involving thorough audits and continuous improvement. While medical refurbishment companies aren’t required to get this certification, Soma Tech Intl consistently re-certifies, proving that their facility, products, and production process meet the highest safety and performance standards. This certification reflects Soma Tech Intl’s dedication to quality assurance and provides healthcare providers confidence that their refurbished equipment is safe and reliable. By adhering to ISO 13485:2016, Soma ensures that their products are refurbished under the same standards as newly manufactured medical equipment.

Soma Tech Intl’s Comprehensive Refurbishment Process

At Soma Tech Intl, the refurbishment process is designed to restore each unit to its original performance and safety standards. It starts with a technical refurbishing process where our highly trained and certified biomedical engineers, many with OEM experience, disassemble the system and check each area, replacing components per OEM recommendations. This includes individual circuit board testing and repair, resolution of any pending recalls, and upgrading any necessary software. Engineers take a preventative approach to identify parts that might seem functional but are on the verge of failure. This is followed by replacing necessary parts, assembly, and system calibration. An operational test of the system follows, during which individual components are assessed. This includes testing the speakers, indicators, switches, and other critical elements. Additionally, it checks whether the software routines are functioning as intended. Any detected failures are promptly corrected and retested to ensure proper operation. A functional test is also conducted to assess various parameters and the overall operation of the system, followed by an electrical safety inspection. All readings are thoroughly documented to ensure complete transparency throughout the process. These results are compiled into a detailed engineering testing report. The parameter testing and electrical safety inspection further validate that the device meets the manufacturer’s performance specifications, ensuring it is safe for use in patient care. In addition to ensuring the equipment works flawlessly, Soma Tech Intl also restores its appearance. The cosmetic restoration process includes repairing or replacing broken panels, handles, and pieces. As well as cleaning, sanding, painting, and adding new decals to bring the device back to its original look. This enhances the equipment’s aesthetic appeal and ensures its durability in a clinical setting. Before any unit is labeled “patient-ready,” it undergoes a final round of testing and inspection. This step includes re-testing the devices’ performance, verifying the engineering report’s accuracy, and checking the physical appearance one last time. Only then is the unit approved for shipment, complete with a warranty.

Conclusion

Quality assurance in refurbished medical equipment isn’t just a matter of compliance; it’s a commitment to patient safety and effective healthcare delivery. By choosing a refurbishing company that prioritizes quality, like Soma Tech Intl, healthcare providers can ensure that their equipment is both reliable and safe, capable of performing at the highest level when it matters most. A well-executed process in an industry without formal regulations is a testament to a company’s dedication to quality, providing healthcare providers with reliable, safe, and effective equipment.