The medical industry is abuzz with discussions about the potential for additional government regulations regarding the manufacture, refurbish and maintenance of equipment. Ongoing conversations among industry leaders, stakeholders and experts revolve around the importance of quality standards and how new regulations will impact the service industry.
As an OEM of ultrasound equipment, GE Healthcare understands the need for quality and is focused on driving high standards for its multi-vendor probe repair services.
TechNation: Why does quality matter for ultrasound users?
GE Healthcare: In Ultrasound, most service related issues involve the probe. In fact, we have seen evidence that 1 in 4 probes in clinical use today have some sort of defect. For ultrasound users, probe issues make up the most time, effort, and financial risk. Because of this, it’s critical for HTM professionals to understand what defines quality repair as they select their service provider.
TechNation: Can you tell our readers more about GE Healthcare’s leadership in probe repair services?
GE Healthcare: We know how crucial it is that ultrasound equipment remains patient-ready. Downtime due to probe failures can cost valuable resources and reduce overall quality of care. That is why GE Healthcare has been expanding our probe solutions and services. On May 29, 2013, GE Healthcare acquired Unisyn Medical Technologies’ Transactional Business, which includes their multivendor probe repair services and proprietary test equipment business. With this acquisition, we have been integrating Unisyn’s existing ISO 9001 and 13485 certification into our broader GE Healthcare QMS and investing in the capabilities of the business and operation.
TechNation: How is GE Healthcare preparing for potential additional government regulations in the service industry?
GE Healthcare: Repairs performed on ultrasound probes should be benchmarked to OEM specifications. However, across the industry we are finding that repair quality can be inconsistent and not to the OEM performance standard.
Because we manufacture probes and ultrasound equipment, our GE probe repair services are consistent with our manufacturing standards. Quality is foundational to our organization and drives our probe repair services in the way that we engineer, validate, and repair our probes.Â
In the case of our multi-vendor repairs, our programs were developed to include risk management and regulatory activities to demonstrate compliance with safety regulations. And we apply the same QMS requirements for qualification, risk management, and production and process controls to our multi-vendor probe services as we do to our own probes.
Since the acquisition of Unisyn’s probe repair business, we have taken their existing expertise and applied our knowledge and experience. When a customer sends us a probe, we don’t just repair it; we verify each and every probe to our high quality standard.