With Patient Safety on the Line, Reprocessing Must Be a Top Priority
Over the past several months, the federal government has issued several notices regarding the cleaning, disinfection, and sterilization of medical devices following a series of deaths attributed to improper cleaning. In August, the Food and Drug Administration (FDA) released a safety communication to address reprocessing standards for cleaning ERCP endoscopes. And earlier this month, the Centers for Disease Control and Prevention (CDC) joined the FDA in issuing a notice alerting healthcare providers and facilities about recent infection control lapses due to non-compliance with recommended reprocessing procedures, highlighting a critical gap in patient safety.
The notice, issued on September 11, urges healthcare facilities—including hospitals, ambulatory surgical centers, clinics, and doctors’ offices—that employ reusable medical devices to review current reprocessing practices immediately to ensure that they (1) comply with all steps as directed by the device manufacturers, and (2) have in place appropriate policies and procedures consistent with current standards and guidelines.
The heightened focus on sterile processing has increased in recent months following extensive media reports of instances in which patients were notified of potential increased risk for infection due to “lapses in basic cleaning, disinfection, and sterilization” of both surgical instruments, known as critical items, and non-critical items, like endoscopes that contact mucous membranes or non-intact skin. The root cause of the increased risk appears to be the repeated failure to follow manufacturers’ reprocessing instructions, which has prompted calls by the FDA and CDC for increased training and review of processes and protocols.
Focus on Duodenoscopes
ERCP endoscopes, also known as duodenoscopes, are devices that are used in the diagnosis (and sometimes treatment) of problems in the bile and pancreatic ducts. The intricate design of the duodenoscope is simultaneously its most valuable and problematic feature, specifically the components involved in the side visualization camera functionality. However, given the device’s complex components and subsequent difficulties in cleaning, the FDA determined that duodenoscopes do not provide “reasonable assurance of safety and efficacy.” Nonetheless, the device remains indispensable to the practice of gastroenterology.
Responding to hospitals’ need for concrete direction in responding to these issues, the FDA released four supplemental measures to append to routine cleaning and sterilization for scope reprocessing, recommending that healthcare facilities performing ERCP evaluate whether they have the expertise, training and resources to implement one or more of these options:
While the announcement offers several methods to protect patient safety, the additional measures require additional resources—something that most sterile processing departments don’t have. So while the FDA is trying to offer support, the safety communication frequently directs healthcare workers to refer back to manufacturer instructions for use (IFU).
Are Manufacturer IFU Feasible in the Real World?
Manufacturer’s IFU, while effective in a testing environment, are often difficult to replicate in real time in a working hospital setting. Unlike testing labs, hospital sterile processing departments operate in environments that leave little room for procedural deviation. As medical device technology improves—creating products that are more complex—the associated instrument-specific reprocessing procedures are becoming very labor-intensive and time-intensive. Adding the time pressures of delivering instruments to the OR makes following a 102-step reprocessing document a near-impossibility for most sterile processing departments. To provide some context, facilities can turn around thousands of devices, with the largest hospitals reprocessing up to 40,000 instruments each day.
The recent communications from both the FDA and CDC suggest that hospitals and healthcare organizations develop and maintain their own policies and procedures for instrument reprocessing. While organizations certainly need to monitor their sterile processing departments, expecting them to draft device-specific procedures for sterilizing duodenoscope and other complex instruments is unrealistic, as product design varies not only by type but also by manufacturer.
FDA: Limited Control over Manufacturer IFU
Unfortunately, the FDA only has limited control of what it can require of device manufacturers, namely requesting that manufacturers create IFU that can reasonably be performed in a hospital environment. Apart from that, the FDA has no oversight of device cleaning processes. The FDA has asked all duodenoscope manufacturers to submit relevant criteria for reprocessing, including any special tools required for cleaning, as well as an accompanying catalog number. While this will not ease the work of reprocessing, it is the first step in creating some sort of standard practice among device makers. Additionally, the FDA sent warning letters on August 17 to Olympus, Pentax, and Fujifilm, stating that the companies failed to report scope problems and address cleaning issues. The agency asked the companies to respond with details of how they will fix the situation and prevent future problems. However, the FDA stopped short of pulling duodenoscopes off the market, noting that for most patients, the devices’ benefits continue to outweigh the risks and that, given how many scopes are in use, the risk of infection remains “relatively low.”
Closing the Reprocessing Education Gap
While we await the manufacturer response to the FDA warnings, the industry must continue to move forward. One area where we can make immediate changes is training, as much of the sterile processing profession lacks formal education and/or certification. To date, only seven states—Indiana, Massachusetts, New Jersey, New York, South Carolina, Tennessee and Texas—require surgical technologist certification, and only three, New York, New Jersey, and Connecticut, require certification for sterile processing technicians.
While hospitals invest in hiring skilled surgeons and anesthesiologists and adopt Six Sigma strategies to improve perioperative throughput, they often fail to invest in training their sterile processing team. An integral component of the perioperative team, the sterile processing department directly supports the OR’s ability to function. In fact, surgical case start times depend on efficient, effective instrument reprocessing. Moreover, ensuring that your sterile processing team is appropriately skilled and adequately trained is critical for developing clinically integrated networks.
Next Steps on a Path to Safe Reprocessing
While the benefits of using duodenoscopes outweigh the risks, the entire healthcare industry needs to work together to improve patient safety and mitigate unnecessary harm. One next step that can be taken immediately is changing the perceptions of the sterile processing profession—recognizing the importance of this department to surgical safety and outcomes. Accordingly, we should require certification for all technicians, and hospitals should support their staff members by ensuring that they have received proper training.
But the responsibility for safe duodenoscope use doesn’t rest solely with hospitals and surgical centers. In recent years, healthcare manufacturers have proven themselves capable of incredible, life-changing innovations—the ingestible, pill-sized camera used for diagnostic endoscopy procedures is just one example. Payers, regulators, and policymakers need to challenge manufacturers to 1) revise and simplify cleaning instructions to be easily implemented and replicated in a hospital environment and 2) work toward designing a safer scope. If an affordable disposable scope is out of reach, what about creating scopes with a disposable elevator mechanism (the scope’s most problematic piece) or even an elevator mechanism with a detachable tip to help ensure safer, more effective reprocessing? The FDA warning letters are a step in the right direction but a very small step on a long road to improvement.
Regardless of how we get there, something must be done to improve reprocessing procedures. We can’t continue to leave sterile processing technicians stuck between the proverbial rock and a hard place, where they have to choose between being safe (following 100+ step proprietary cleaning instructions) or being fast (to meet the instrumentation turnaround times for OR procedures). For any healthcare worker dedicated to helping patients, that’s really no choice at all.
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