Specialty reprocessing
Since all the low-hanging fruit has been picked, new FDA clearances are increasingly demanding, both regulatorily and technologically. A company must invest substantial resources in R&D to be able to achieve these clearances.
Over the past five years, specialty reprocessing has largely driven FDA clearances for new devices, thanks to the development of “reprocessing technology,” a series of highly specialized methodologies, standards, validation techniques and testing practices. These include, for example: hemostasis detection capability; micro lumen occlusion detection, cleaning and inspection; hydrophilic coating performance characterization; electronic programable memory decryption, read and write capabilities; advanced visual inspection methodologies, 3D mapping location sensor performance characterization and testing; advanced, custom cleaning validation methodologies; and advanced non-destructive material identification methodologies.
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Reprocessing an advanced electrophysiology mapping catheter with microlumens is a world apart from reprocessing a compression sleeve. This means that beyond optimizing existing reprocessing programs in terms of collection compliance, sound buy-back practices and clinician support, savings can only grow from working with specialty reprocessors or with distributors of specialty reprocessors.
Specialty reprocessors don’t just develop new R&D and regulatory competencies; they have to develop deep clinical skills through frequent interaction with clinicians who – rightfully – insist that they feel comfortable with the new devices – and to understand how the devices should feel and function. Different clinical areas of the hospital have different dynamics. Because of their very narrow focus, specialty reprocessors are also able to create reprocessing programs that are tailored to a specific clinical area. The EP lab is a different landscape than the OR in terms of purchasing decisions, utilization decisions (which device should be used) and others. Specialty reprocessors optimize reprocessing programs specifically for the dynamics of their clinical area.
