News & Articles

A Partnership With Acertara Is Built on Safety and Compliance

The recent release of the FDA’s Final Guidance on remanufacturing of medical devices sent ripples through the healthcare industry. This is especially true for healthcare organizations (HCOs) heavily reliant on reusable medical devices. This new guidance aims to clarify the distinction between servicing and remanufacturing activities, both of which are crucial for ensuring patient safety and device effectiveness. Navigating the complexities of the FDA’s Final Guidance — and implementing its recommendations — can pose challenges for suppliers and HCOs alike.

Challenges HCOs might face moving forward

Understanding the difference between servicing and remanufacturing is essential to verifying compliance and avoiding disruptions to patient care. Testing is required in either case. For servicing, testing must confirm repairs have restored device performance to OEM (original equipment manufacturer) specifications. For remanufacturing — in cases where repairs have significantly altered device performance or intended use — HCOs must verify 510(k) clearance to understand if the device is safe and effective for use with patients. Translating these requirements into action and action into assurance can be challenging for several reasons:

• Resource limitations: Proper servicing requires functionality testing following specific protocols. For HCOs, acquiring the necessary equipment and expertise for in-house testing can be a significant financial investment — both in terms of upfront costs and ongoing maintenance.
• Difficulty finding compliant suppliers: Many HCOs rely on third-party service providers for equipment maintenance and repair. With the new guidance in place, identifying qualified service providers who adhere to the updated regulations becomes critical.
• Verification of accreditations: HCOs must verify the legitimacy of accreditations held by third-party service providers. This can be a time-consuming task, requiring a system for managing and verifying credentials across various service providers — some of whom might be unprepared and slow to provide credentials — and equipment types.

These are just a few of the hurdles HCOs now face when medical equipment needs servicing. That said, these stopgaps can be eliminated in the case of ultrasound equipment maintenance. How? By partnering with Acertara.

We make compliance simple

At Acertara, we’re proud to be an industry-leading partner to HCOs navigating the FDA’s Final Guidance. Our processes for quality testing and assurance are anchored in rigorous standards and internationally recognized accreditations. For us, quantitative testing to optimize device performance is integral to due diligence. And this level of due diligence has been our baseline for decades, long before the FDA’s definitions for servicing and remanufacturing made it a requirement.

ISO 17025 accreditation

Our state-of-the-art laboratory is accredited under ISO/IEC 17025:2017 — the gold standard for testing and calibration laboratories across the globe. This accreditation signifies our technical competence and ability to generate precise and accurate test results and calibration data. You can be confident that Acertara’s measurements and calibrations are traceable to national standards, ensuring the utmost reliability. We maintain a stringent quality assurance process, continuously demonstrating our expertise through regular reassessments and participation in proficiency-testing programs.

Advanced diagnostics with ATLAS™

We leverage our cutting-edge ATLAS™ diagnostic tools to provide unparalleled assessments of ultrasound probes — down to the individual crystal level. This comprehensive analysis ensures exceptional accuracy in identifying even the most subtle performance issues, encompassing sophisticated probes from leading manufacturers like Philips, GE, and Siemens.

By partnering with us, HCOs can be certain repairs restored each probe to OEM specifications, guaranteeing optimal performance and patient safety.

Find patient-safe ultrasound maintenance at Acertara

While the FDA’s Final Guidance offers a much-needed roadmap for ensuring the safety and efficacy of reusable medical devices, navigating its intricacies can be a complex undertaking for HCOs. Partner with experts at Acertara for ultrasound equipment servicing. Minimize risks of noncompliance. Ensure patient safety with effective maintenance. Maximize equipment lifespan and optimize performance. And reduce total cost of ownership for critical ultrasound devices — all while elevating patient care.