Innovative Health offers 45 unique reprocessed electrophysiology (EP) device families from 5 manufacturers, resulting in 600+ available SKUs. We have built the fastest-growing reprocessed EP device portfolio in approximately 3 years, during which more than 32 submissions have been sent to the FDA. Our devices include diagnostic and vascular ultrasound imaging catheters, mapping catheters, introducer sheaths, steerable and fixed EP catheters as well as Reusable EP cables: If it can be reprocessed and used in the EP lab, Innovative Health offers it.
However, it doesn’t end there. Our company has made a commitment to our customers: We will continue to break into new technologies to be able to get FDA clearance for more complex devices – even devices that may not be considered “reprocessable." The reason for this commitment is simple: If a reprocessing company stops getting new clearances, savings will drop over time – and we have witnessed this again and again. This is because new technologies and devices are constantly being introduced, especially in a rapidly growing procedure area like electrophysiology. So when new technologies take over from old technologies, hospitals lose reprocessing savings – unless there is an FDA clearance to reprocess the new technology. Since our first clearance, Innovative Health has received a new FDA clearance every 44 days and we have several active files under review with FDA. That compares with a new FDA clearance every 180 days for Stryker and every 210 days for SterilMed, during the same time period. Innovative Health gets new clearances 4 times faster than its closest competitor…
"If a reprocessing company stops getting new clearances, savings will drop over time – and we have witnessed this again and again."
We are committed to not allow savings to drop off over time, and to deliver on this, we have focused on building an entirely new type of technology to reverse engineer, reset software, clean, and test more complex devices. We call this “reprocessing technology”. It consists of a set of competencies, capabilities, methods, standards and fixtures that make it possible to reprocess – and reuse – devices with EPROM (erasable programmable read-only memory) chips, microlumens, location sensors, hydrophilic coatings and other traditional barriers to reprocessing. Some of the capabilities involved are listed below:
- Hemostasis detection capability
- Joint leak detection capability
- Macro lumen occlusion detection, cleaning and inspecting
- Micro lumen occlusion detection, cleaning and inspecting
- Hydrophilic coating performance characterization
- Hydrophilic coating detection, application and/or removal
- Electronic programmable memory decryption, read and write capabilities
- Advanced visual inspection methodologies
- 3D mapping location sensor performance characterization and testing
- Ultrasound Imaging performance characterization and testing
- Dielectric breakdown assessment for insulation per IEC 60601
- Patient leakage testing for medical devices per IEC 60601
- Custom and advanced cleaning validation methodologies
- Like-for-like component replacements
- Injection molded component replacements
- Mechanical characterization of medical devices
- Advanced non-destructive material identification methodologies
- Advanced non-destructive wall thickness measurement for catheters
- Advanced sterile packaging design and development
As the head of R&D at Innovative Health, I am proud of my engineers, who have made this possible. They come from a reprocessing background, from the original manufacturers and from highly specialized engineering positions in other industries. In our R&D group, everybody has his or her specialty, and contributes with this specialty to our ongoing pursuit of FDA clearances. I would like to invite you to watch the video in the link below. In this video, some of my engineering team members present themselves and the functions they are responsible for. Our Director of R&D describes how we test imaging catheters and how we address location sensors and the existence of EPROM chips that are programmed to prevent reprocessing. Our R&D engineer for emerging technologies describes how we constantly work on new devices to understand if they can be reprocessed – and how we target these devices by looking at how much they represent in cost savings for the EP lab. Other Innovative Health engineers discuss how we clean and inspect introducer sheaths and how we design fixtures and test methods. Finally, our packaging engineer addresses our environmental focus on ensuring that packaging doesn’t unnecessarily add to the landfills – and how Innovative Health approaches packaging design so as to minimize costs and optimally protect the devices.
FDA’s Innovative Health clearances of Agilis and ViewFlex represent the adoption of new technologies and standards for reprocessing associated with what we call “reprocessing technology”. These clearances have opened the door for the clearance of more complex devices with similar technologies. However, the bar for FDA reprocessing clearances is higher than ever, which reflects a continued commitment to enable reprocessing and better EP lab economics – while ensuring patient safety.
Watch the video here: