La importancia del control de calidad en los equipos médicos restaurados

1. A gap in refurbishment standards
2. Why is quality control important?
3. ISO 13485:2016 certification
4. The comprehensive restoration process of Soma Tech Intl
5. Conclusion

In the healthcare sector, medical equipment is essential for optimal patient care, from diagnosis 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, just as the original equipment manufacturer (OEM) intended. This underscores the crucial role of quality control, especially for refurbished medical equipment, where attention to detail is paramount.

A gap in refurbishment standards

Unlike new medical devices, where FDA regulations dictate performance standards, there are no formal guidelines governing the refurbishment process. This lack of regulation means that the quality of refurbished equipment can vary significantly among vendors. It also places the responsibility on procurement officers to research and ensure they purchase from a reputable company. Establishing a comprehensive refurbishment process that meets high standards is essential to ensuring that refurbished equipment is reliable and safe for patients. Without a standardized process, refurbishment companies may employ different methods, some of which may not fully restore equipment to its original condition. This variability introduces risks to patient safety and complicates clinical workflows. Healthcare providers should choose partners that adhere to comprehensive quality assurance protocols that ensure refurbished devices meet the same performance standards as new equipment.

Why is quality control important ?

There is a lot at stake when it comes to the performance of medical equipment. A failure in a clinical setting could have tragic, even fatal, consequences. Quality control is not just important, but essential. A comprehensive refurbishment process ensures that the equipment performs as well as when it left the original manufacturer. This gives healthcare professionals confidence that refurbished devices will deliver safe and effective patient care. Quality control in refurbished medical equipment goes beyond simply ensuring that the device powers on. It includes a thorough assessment of the equipment’s functionality, safety features, and reliability. For example, ventilators and anesthesia machines are life support systems in critical care settings. Refurbishment must go beyond simply powering on the unit and performing a ventilation check. A thorough process must also include measuring the volume and pressure accuracy of the gases, checking the gas mixture, ensuring that backup systems function in the event of a failure, and verifying that anesthetic gases are not exposed to medical personnel. Furthermore, inspections are necessary to identify parts nearing failure, which may not always be visible through the original manufacturer’s standard preventative maintenance procedures. The refurbishment must also restore the device’s original aesthetic appearance, preventing contamination during the process, and undergo a further inspection to ensure that performance parameters are maintained. Following this process, the system should successfully pass pre-operative biomedical verification in a surgical setting. A comprehensive quality control process simulates real-world use to guarantee that the equipment is ready for patient use.

ISO 13485:2016 certification

ISO 13485:2016 is an internationally recognized certification that demonstrates a medical equipment company’s commitment to rigorous quality management standards. Obtaining and maintaining this certification is a demanding process involving comprehensive audits and continuous improvement. While medical refurbishment companies are not required to obtain this certification, Soma Tech Intl consistently recertifies , demonstrating that its facilities, products, and production processes meet the highest standards of safety and performance. This certification reflects Soma Tech Intl’s dedication to maintaining high quality standards and providing healthcare providers with the confidence that their refurbished equipment is safe and reliable. By adhering to ISO 13485:2016 , Soma ensures that its products are refurbished to the same standards as newly manufactured medical equipment.

The comprehensive restoration process of Soma Tech Intl

At Soma Tech Intl , the refurbishment process is designed to restore each unit to its original performance and safety standards. It begins with a technical refurbishment process where our highly trained and certified biomedical engineers, many with original equipment manufacturer (OEM) experience, disassemble the system and inspect every area, replacing components according to OEM recommendations. This includes testing and repairing each circuit board, resolving any outstanding recalls, and updating necessary software. The engineers take a proactive approach to identify parts that may appear functional but are nearing failure. The necessary parts are then replaced, and the system is reassembled and calibrated. An operational test of the system is also performed, during which individual components are evaluated. This includes testing speakers, indicators, switches, and other critical elements. Software routines are also verified to ensure they function correctly. Any faults detected are promptly corrected and retested to guarantee proper operation. A functional test is also performed to evaluate various parameters and the overall system performance, followed by an electrical safety inspection. All readings are meticulously documented to ensure complete transparency throughout the entire process. These results are consolidated into a detailed engineering test report. Parameter testing and electrical safety inspection further validate that the device meets the manufacturer’s performance specifications, guaranteeing its safe use in patient care. In addition to ensuring flawless equipment operation, Soma Tech Intl also restores its appearance. The cosmetic restoration process includes repairing or replacing panels, handles, and broken parts, as well as cleaning, sanding, painting, and adding new decals to return the device to its original look. This enhances the equipment’s aesthetics and ensures its durability in the clinical environment. Before any unit receives the «patient-ready» label, it undergoes a final round of testing and inspection. This step includes retesting the device’s performance, verifying the accuracy of the engineering report, and checking its physical appearance one last time. Only then is the unit approved for shipment, including the warranty.

Conclusion

Quality control in refurbished medical equipment goes beyond regulatory compliance; it involves a commitment to patient safety and the effective delivery of healthcare services. By choosing a refurbishment company that prioritizes quality, such as Soma Tech Intl , healthcare professionals can ensure their equipment is reliable and safe, capable of performing at its best when they need it most. A well-executed process in an industry lacking formal regulations demonstrates a company’s dedication to quality, providing healthcare professionals with dependable, safe, and effective equipment.