Clearance and Adherence. Healthcare organizations should also require strict adherence to FDA clearance guidelines from their reprocessors. No shortcuts should be taken when it comes to when data needs to be submitted to FDA, and no shortcuts should be taken when it comes to the diligent collection of data needed for FDA clearances. The FDA clearance process is the most cumbersome, expensive, and time-consuming pathway to legally market a reprocessed device. There are other pathways, and at times, these are appropriate, but only within the FDA guidelines. Without these requirements, providers risk partnering with reprocessors who may have a more relaxed view on the need for FDA clearances to market reprocessed devices.

A Focus on Cost Savings. Hospitals should expect their reprocessing partners to maintain a singular focus on maximizing the results from the hospital’s reprocessing program. In other words, consideration for overall corporate profit that may suffer from reprocessing should have secondary importance versus considerations for maximizing cost savings and environmental impact for the hospital. Without this requirement, there is a risk that reprocessors will restrain their reprocessing activities to maximize profits—for example, by offering only limited quantities of reprocessed devices or avoiding the use of FDA clearances to bring greater cost savings to the hospital.


Ethical Practices. Healthcare organizations should also expect strict rules for corporate ethics, transparency, and accountability from their reprocessing partners. Deceitful communication, lack of transparency about program results, and similar practices should not be tolerated. Without these expectations, hospitals risk working with reprocessors who may have a more relaxed view on corporate ethics and program transparency.

A reprocessor’s commitment to high standards is not only about individual performance but about protecting the credibility and progress of the entire reprocessing industry. A more successful, more ethical, and results-oriented industry benefits all stakeholders, and high standards support peer accountability within the industry. Oversight isn’t constant, and it is partially the responsibility of the reprocessing company itself. When reprocessors hold themselves and each other accountable to high standards, the entire industry is strengthened, and the risk of harm to patients and hospitals is reduced.

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