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Getinge clarifies FDA Medical Device recall communication

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Report: Expanding Reprocessing Options for Single-Use Cardiovascular Devices Reduces Costs

With the reuse of costly devices offering significant cost savings to health care providers while reducing environmental impacts, reprocessing options for cardiovascular devices are expanding to include devices initially limited to single-use applications, observes data and analytics company GlobalData.

Jacob Fletcher, medical analyst at GlobalData, comments, “Single-use cardiovascular devices like diagnostic electrophysiology catheters, for example, have become increasingly sophisticated in design and function in recent years. 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. In the U.S., the FDA selects which single-use devices 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 US amounted to over $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.

Fletcher adds: “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.”



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