Diagnostic Ultrasound Catheters

Reprocessed diagnostic ultrasound catheters are made available to hospitals at a lower cost without compromising safety and performance of the devices.

Diagnostic ultrasound catheters use a longitudinal side-fire imaging plane. Anatomy, as well as deployed devices, are shown in standard ultrasound format. The catheter also contains a 64-element phased array transducer that provides high-resolution 2D imaging.

Innovative Health offers reprocessed diagnostic ultrasound catheters used in the electrophysiology lab and the cardiac cath lab. These devices are proven to be as safe and effective as new devices by undergoing stringent validation and verification activities. Innovative Health achieves this high level of safety and performance through an efficient process of cleaning, performance testing, inspection and sterilization. Our reprocessing technologies are cutting edge and proven through years of experience.

Reprocessing helps hospitals achieve better financial results – reprocessed devices are often half the price of new ones – without compromising quality and safety. At the same time, the use of advanced third-party reprocessing provides significant environmental advantages.

Reprocessing establishments are more stringently regulated by FDA than are the manufacturers of the original devices. Innovative Health’s reprocessed diagnostic ultrasound catheters are cleared by the FDA. To meet FDA criteria for safety and effectiveness, the reprocessed devices undergo multiple validations, including, but not limited to, cleaning, sterilization, and functional performance.

Reprocessing Diagnostic Ultrasound Catheters involves the following steps*:

*Some tests are performed during validation activities only.

Developing a 510(k) to achieve FDA Clearance to Reprocess Single-Use Devices

The FDA requires reprocessors to demonstrate that a reprocessed device is substantially equivalent to that of the Original Manufacturer (OM) device prior to marketing the device. The FDA is able to determine that the device is substantially equivalent from the evidence presented in a 510(k) submission.

Cleaning validation based on the AAMI TIR30 and FDA guidelines to ensure that the cleaning process reduces residual biomarkers on devices to acceptable levels to ensure the cleanliness of the devices.

Devices are tested to ensure an acceptable level of bacterial endotoxins in accordance with ANSI/AAMI ST72 to support the non-pyrogenic labeling.

Biocompatibility testing is performed in accordance with AAMI/ANSI/ISO 10993-1 and related subparts to ensure devices do not present adverse effects such as toxicity, sensitization, and irritation when in contact with the patient.

Functionality testing is performed based on the relevant clinical applications and applicable industry standards. Each device is inspected and function tested prior to packaging and labeling.

Innovative Health devices are sterilized using Ethylene Oxide (EO). The EO sterilization process includes preconditioning, sterilization and aeration. The EO sterilization cycle is validated in accordance with applicable industry standards and requirements such as AAMI/ANSI/ISO 11135 to achieve a minimum sterility Assurance Level (SAL) of 10-6. In addition, devices are validated to have acceptable sterilant residual levels after aeration.

For a more detailed description of what goes into an Innovative Health FDA clearance, please ask your contact for additional information.

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