Many devices used in cardiac catheterization labs and electrophysiology suites are single-use by design. Many of these devices — such as diagnostic and therapeutic electrophysiology catheters and intravascular ultrasound devices — have seen rapid technological advancement in recent years with evolving capabilities. The adoption of these increasingly sophisticated devices is costly and can place a burden on healthcare providers seeking to balance patient care with cost of delivery.
Device reprocessing — the act of cleaning, disinfecting, sterilizing, testing, and repackaging medical devices — offers a solution to some of these challenges by allowing for repeated use at a reduced cost. Medical device reprocessing has expanded over recent years to include a variety of single-use cardiovascular devices, expanding the range of procedures that can leverage cheaper reprocessed devices.
As an example, earlier this week third-party device reprocessor Innovative Health announced it had received US Food and Drug Administration (FDA) 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 more than $ 315m last year, with individual catheters averaging nearly $ 750 a unit. Opportunities to reduce device repurchasing could help reduce procedure costs and keep this technology accessible to patients.
In cardiac electrophysiology labs, where expensive single-use devices are frequently used, device reprocessing has been utilized to a significant extent in many regions. A 2020 survey of European Heart Rhythm Association members across 34 countries found that more than 67% of responders had previously or were currently using reprocessed cardiac electrophysiology devices. At a higher level, a recent report from the Association of Medical Device Reprocessors estimated that total device reprocessing efforts saved American hospitals $ 372m in 2020 alone, further highlighting its savings potential.
Limitations remain in terms of which devices can be effectively reprocessed, as servicing more complex devices can be challenging to do without compromising precision or durability. In addition, not all device designs are compatible with existing reprocessing technologies. Despite this, device reprocessors have continuously advanced their capabilities to safely service and repurpose devices that were initially limited to a single use. High-cost environments like cardiac catheterization and electrophysiology labs stand to benefit especially, improving their financial stability and ability to provide patient care.