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But collaboration between device manufacturers, reprocessors, and regulatory bodies is needed to further enable device reuse.
July 15, 2022
By: Michael Barbella
Managing Editor
With the reuse of costly devices offering significant cost savings to healthcare providers while reducing environmental impacts, reprocessing options for cardiovascular devices are expanding to include devices initially limited to single-use applications, GlobalData claims. “Single-use cardiovascular devices like diagnostic electrophysiology catheters, for example, have become increasingly sophisticated in design and function in recent years,” said Jacob Fletcher, a medical analyst at GlobalData. “As improved technologies are rapidly adopted, healthcare providers often face the challenge of balancing care with rising device costs. Device reprocessing offers a means of controlling procedure.” Due to the risk of contamination, device reprocessing is subject to strict regulation in most regions. The U.S. Food and Drug Administration (FDA) selects the kinds of single-use devices that are eligible for reprocessing based on the device’s design and overall risk. Third-party device reprocessors, like NEScientific and Innovative Health, are subject to the same regulations as original equipment manufacturers, and must obtain FDA 510(k) clearances for devices they include in their portfolio. Collaboration between device manufacturers, reprocessors, and regulatory bodies is needed to further enable device reuse. Professional reprocessing companies are continuously improving their capabilities to service more complex devices. A prime example of this came from device reprocessor Innovative Health, as the company announced it had received clearance to reprocess the market leading Philips Eagle Eye Platinum Intravascular Ultrasound (IVUS) catheter. According to GlobalData, IVUS catheter sales in the United States amounted to more than $315 million last year, with individual catheters averaging nearly $750 per unit. Opportunities to reduce repurchasing of these advanced devices could help to keep the technology accessible to patients. “As device reprocessors work to expand their device catalogues, reuse of once single-use devices may become more of a common practice. High-cost environments like cardiac catherization and electrophysiology labs stand to benefit especially, improving their financial stability and ability to provide patient care,” Fletcher said.
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