However, the practice of labeling certain devices “single-use” had only recently become a common practice: Original manufactures determine this designation. Regulatory risk was introduced: Since the label says “single-use”, you should not be able to reprocess and reuse the device.
FDA’s regulation meant that only FDA regulated, third-party reprocessing companies with advanced engineering and regulatory competencies could reprocess single-use devices, and only when they could successfully present FDA with data that demonstrated the reprocessed devices were safe and functionally similar to new devices.
Even on this regulatory backdrop, for years, clinicians questioned the infection risk associated with the use of reprocessed single-use medical devices. Reprocessing had only just been established, and clinicians did not feel certain that single-use devices could actually be cleaned, inspected, and tested.
Since these formative years of the single-use devices reprocessing industry, there has always been risk associated with the use of its reprocessed devices. However, as reprocessing became more established, and more data existed to disprove concerns about patient safety, new types of risks were introduced into the clinical and administrative discourse about reprocessing.
While you might have thought that after a while, concerns about risk would go away, throughout the history of reprocessing, the original manufacturers, whose devices were being reprocessed, has continued to re-invent the risk narrative to curtail the use of reprocessed devices.
Regulatory risk
Prior to 2000, “single-use” labeled devices were increasingly introduced by original manufacturers to reduce the reuse of their devices or to avoid publishing instructions about reprocessing (because reprocessing was not desirable or possible). Technically, the practice of reprocessing and reusing “single-use” devices was not legal, but it was not until the FDA came up with a regulatory framework that made third-party reprocessing legal that hospital reprocessing of single-use devices was effectively stopped. It can be said that a new category of devices was invented with this regulatory evolution: The reprocessable device.
Infection risk
Although the Government Accountability Office’s 2000 report on single-use device reprocessing established that “Available evidence suggests that some types of SUDs (single-use devices) can be safely reprocessed”, clinicians broadly questioned the safety of using such devices, due to the infection risk associated with the practice.
The report continued to observe that “the evidence suggests that some SUDs can be safely reprocessed if appropriate cleaning, testing, and sterilization procedures are carefully followed. However, SUD reprocessing is not invariably safe, and relatively little is known about the practice of SUD reprocessing in health care facilities. For this reason, FDA has taken steps to increase its oversight of SUD reprocessing. Nonetheless, the new framework is cumbersome and will be difficult to implement.”
It was a surprise to original manufacturers, on whose initiative the regulation had been put in place, that third party reprocessors were actually able to meet the requirements of the new regulation, since “the framework will extend enforcement of all of FDA’s requirements for device manufacturers to hospitals that reprocess SUDs and third-party reprocessing firms.” Meeting the same requirements as a manufacturer seemed impossible – and yet, the first FDA reprocessing clearances were issued in 2001 and 2002.
In spite of growing evidence to the contrary, clinicians continued to hesitate using reprocessed devices due to infection risk throughout most of the 2000s. In 2006, Daniel Schultz MD, Director, Center for Devices and Radiological Health endorsed the practice of single-use device reprocessing: “The types of adverse events reported to be associated with the use of SUDs are the same types of events that are also being reported for new, nonreprocessed devices […] SUDs that meet FDA's regulatory requirements are as safe and effective as a new device.”
In spite of this, other voices in the industry continued to emphasize infection risk. Stephen Ubl, president and CEO of AdvaMed said, “The reprocessing of medical devices designed to be used once is inherently risky.” Supporting the same perspective on reprocessing, Mark Leahey, executive director of the Medical Device Manufacturers Association, said “The first priority is safety. Yet, while SUD advocates talk about cost savings, can anyone actually point to a patient bill that reflects savings attributed to the use of SUDs?”
Legislation introduced in Massachusetts, Virginia, and Rhode Island would require hospitals and doctors to notify and obtain consent from patients before reprocessed devices could be used in their procedures. Bob Franks, president of the HealthCare Institute of New Jersey said, “The Food and Drug Administration hasn't done enough to either protect or inform the public of the dangers of reprocessed single-use devices. Lacking adequate federal oversight, states need to step in to ensure the public's safety.”
Functional risk
The second report from the Government Accountability Office was published in 2008, and it effectively changed the risk narrative. The report stated: “FDA oversight has increased, and available information does not indicate that use presents an elevated health risk.”
The report also firmly establishes that there is a category of devices that are single-use, yet reusable: “A device may be labeled as single-use because the manufacturer believes that it cannot be safely and reliably used more than once, or because the manufacturer chooses not to conduct the studies needed to demonstrate that the device can be labeled as reusable […] Some devices fall into another category—they are labeled and marketed by the original manufacturer as single-use devices (SUD), but with clearance from FDA are marketed after being reprocessed for reuse––that is, they are cleaned, sterilized, and performance-tested by one of numerous entities that are in business to reprocess them for reuse.”
Effective, the jury deliberated – the accused is innocent: There is no added infection risk. However, manufacturers quickly came up with a new narrative, designed to sow confusion and doubt about the value of reprocessed single-use devices: The functionality of the devices may be compromised after reprocessing. In the functional risk era, clinicians started questioning whether location sensors were compromised during reprocessing, whether the equipment (like generators) would recognize the devices, whether re-calibration of the device was necessary, and whether – in general – the clinician risked that the device would not function like new.
This was a powerful narrative, and many clinicians turned away from using reprocessed devices, not because they would harm the patient, but because they wouldn’t allow the clinician to practice optimally.
The acquisition of Ascent by Stryker in 2009 and SterilMed by Biosense Webster in 2011 never really had the effect of “mainstreaming” reprocessing, since neither acquirer made reprocessing a central part of their value proposition. The performance risk mindset continued well into the middle of the decade, with manufacturer reps emphasizing that since they didn’t know hoe devices were reprocessed, they couldn’t recommend using them.
Punitive risk
However, clinicians gradually came to accept that the reprocessed devices actually functioned like new (an aspect of reprocessing that had already been codified in FDA’s regulation from 2000, which required “substantial equivalence”). Manufacturers had to shift the risk narrative away from the clinicians and to the administrators, from lab managers to service line leaders: If the lab was to use reprocessed devices, they risked not that the patient got infected, they risked not that the devices wouldn’t perform, but they risked that the procedures simply could not be completed, because punitive measures would be deployed by the manufacturers.
The risk is no longer about the patient or about the doctor – it has become directly about the manufacturer’s willingness to respect the hospital’s right to choose the less expensive, reprocessed devices. Under normal circumstances, hospitals could simply turn to other providers, but market dominance has allowed manufacturers to largely avoid such demand-shifting.
In summary, while initial hesitation from clinicians to use reprocessed devices and even later hesitation about the functionality of the device - were based on genuine concerns about the patient, the current risk associated with reprocessing simply has to do with manufacturer punitive reactions to reduced profitability.
In a landmark decision from May this year, by a federal jury in California federal court, one manufacturer was found guilty of unlawful tying and predatory and anticompetitive conduct to prevent hospitals from using reprocessed devices. Hopefully this puts an end to the punitive risk era – and to manufacturers constant reinvention of new risk narratives to block hospitals from realizing critical savings.