The Importance of Safety and Technological Competencies in Reprocessing
After regulation in the early 2000s, the reprocessing market grew rapidly as hospitals embraced reprocessing as a premier cost reduction strategy. Since then, growth has slowed considerably, and the differences between reprocessors are beginning to play a role. What is important in a reprocessing program? Number of clearances? Number of customers? Service? Price, Safety? Volume? Potentially any of these could be the core strategy of a reprocessing company.
However, as outlined in this month’s whitepaper, a key premise of reprocessing – regardless of strategy – needs to be the continuous pursuit of new 510(k) clearances to create opportunities to replace savings from obsolete devices and grow the savings overall. Without new 510(k) clearances, a reprocessing program will quickly slow down and stop producing savings results.
Innovative Health has made it a core strategy from the beginning to build strong technological competency in order to include new technologies and devices in the reprocessable portfolio while ensuring that the inclusion of progressively more complex devices does not compromise safety.
Pursuing new technologies in reprocessing is important for the hospital: Hospitals should expect their reprocessors to do this.
Pursuing new technologies in reprocessing is important for the hospital: Hospitals should expect their reprocessors to do this. However, not all reprocessors are created equal – some have the technological and scientific wherewithal for this, some have a different focus. A recent Class 1 recall for one of the largest reprocessors on a new device type shows the importance of clearly understanding the reprocessor’s level of technological competency as well as safety policy.
Be sure to ask the tough questions of your reprocessor when they pursue new technologies and offer them to you for use in situations where patient safety is at risk:
- Does the reprocessor fully understand the clinical use of the devices?
- Does the reprocessor have a strong focus on safety, not just on revenue, when venturing into new device functionality?
- How does the reprocessor handle technical complexity in new technologies?
- How does the reprocessor test reprocessed devices to make sure they don’t fail and become a safety issue?
- Is the reprocessor a member of the Association of Medical Device Manufacturers (AMDR)? AMDR members have committed to very strict standards for safety and device quality.
Ideally – visit your reprocessor, spend time with the engineers, quality staff, and inspectors - and see for yourself!
Click below to discover Innovative Health's latest white paper, The Industry That Took A Nap
