Acertara: Your Partners in Compliance With FDA Guidance
Recent FDA guidance on remanufacturing medical devices has shed light on the crucial distinction between repair and remanufacturing activities. Ensuring proper maintenance and repair of reusable medical devices is essential for both patient safety and continued functionality throughout equipment lifespan. Navigating the new guidelines and complying with the testing requirements can be a challenge for healthcare providers. Here’s how we can help.
How the FDA’s Final Guidance will impact providers
The FDA’s guidance on remanufacturing medical devices brings much-needed clarity to the world of probe repair. Previously, the line between repair and remanufacturing activities could be blurry. Now, the guidance emphasizes the importance of testing to ensure repairs maintain patient safety and device effectiveness.
Here’s what this means for healthcare providers (HCPs):
- Proper testing is a requirement for servicing and remanufacturing. Simply replacing a component no longer guarantees a repair. HCPs need to ensure the service provider conducts comprehensive testing to verify the repaired probe meets the original equipment manufacturer’s (OEM) specifications or qualifies as a remanufactured device with the required 510(k) clearance.
- Repairs must achieve substantial equivalence to OEM specifications. For repairs that don’t require a 510(k), testing must demonstrate “substantial equivalence” to the OEM specifications. This means the repaired probe performs identically to the original in terms of safety, efficacy, and intended use.
- Compliance should be a top priority. Failure to adhere to these guidelines can lead to disruptions in service, legal repercussions, and — most critically — compromised patient safety. HCOs are responsible for ensuring the probes they use are compliant with regulatory requirements.
How Acertara has exceeded standards from the start
Long before the FDA issued its Final Guidance, Acertara has been a champion for the highest standards in probe repair. We’re committed to ensuring the safety and efficacy of repaired probes, going above and beyond the baseline requirements.
A cornerstone of this commitment is our comprehensive testing program. Every probe repaired by Acertara undergoes a battery of tests by a long list of well-established industry standards:
- IEC 60601-1: General requirements for basic safety and essential performance
- IEC 60601-1-2: Electromagnetic compatibility requirements and tests
- IEC 60601-2-37: Particular requirements for the safety of ultrasound devices
- IEC 62353: Test after repair of medical electrical equipment
- ISO 10993-1: Biocompatibility of patient contact materials
- IEC 62359: Acoustic power
By adhering to these stringent standards — in conjunction with FDA Ultrasound Submission Guidance — Acertara ensures each repaired probe delivers the same level of performance and safety as a new one.
Looking ahead, we’re not content simply meeting the FDA’s standards; we’re dedicated to exceeding the expectations set by the new guidance. We continuously invest in research and development to refine our testing procedures and stay ahead of the curve in probe repair technology.
Acertara partners with HCPs for higher standards and safer care
Acertara doesn’t just provide compliant probe repair; we collaborate with HCPs to offer full access to detailed testing data for repaired probes. This level of transparency fosters trust and empowers HCPs to confidently demonstrate their probes meet regulatory requirements.
We also understand the unique needs of each healthcare provider. We partner with them to develop customized service plans to optimize probe performance and ensure regulatory compliance. By working together, we can establish best practices for probe maintenance and repair within your facility — no matter your protocols.
Acertara’s dedication goes beyond technical expertise. We’re committed to patient safety, and we always have been. That’s why we’ve historically held ourselves to the highest standards regardless of formal requirements. Partnering with us allows HCPs to focus on what they do best — delivering exceptional patient care — with the peace of mind that their probes are repaired compliantly and effectively.
Find your partners in patient care and compliance
Compliant probe repair is no longer just about restoring device functionality; there’s a significant emphasis on quality control for the sake of patient safety. For Acertara, this is nothing new. Our commitment to exceeding the FDA’s requirements and collaborating with healthcare providers goes above and beyond these new guidelines.
By partnering with us, HCPs gain a dedicated team of experts in ultrasound repair, performance testing, and regulations — a team with a track record of approaching equipment quality and safety the right way since day one. It’s continued proof that we don’t merely follow best practices; we define them.