Calling duodenoscope deaths ‘Preventable Tragedies,’ Senate committee demands reform

Contaminated duodenoscopes sickened at least 250 people worldwide between 2012 and Spring 2015, and the Senate’s Health, Education, Labor, and Pensions Committee deemed the illnesses and resulting deaths preventable tragedies. The Committee’s investigation into the outbreaks revealed wrongdoing and/or errors committed by device manufacturers, hospitals, and the FDA that led to a lengthy investigative process, during which additional patients were infected (see Olympus pressed for information about response to superbug outbreaks, Health Law Daily, June 11, 2015). In a January 13, 2016 report, the Committee, led by Ranking Minority Member Patty Murray (D-Wash), made several recommendations for preventing infections related to medical devices, including the implementation of a robust medical device safety surveillance system similar to the existing Sentinel system that monitors drugs.

Flawed investigation

In September 2013, the Centers for Disease Control and Prevention (CDC) notified the FDA of an outbreak of infections at a Chicago-area hospital linked to a duodenoscope manufactured by Hoya Corporation PENTAX Life Care Division (Pentax). Around the same time, a Seattle hospital linked infections to a duodenoscope manufactured by Olympus Medical Systems (Olympus). The hospitals at issue had cleaned the duodenoscopes pursuant to manufacturer instructions. Although the FDA began investigating closed channel duodenoscopes, devices used in endoscopic retrograde cholangiopancreatography (ERCP) procedures at that time, the Committee noted that the FDA did not issue a safety alert to hospitals for at least 17 months. Further,the agency did not provide hospitals with additional measures to supplement reprocessing of duodenoscopes for reuse for nearly two years, during which at least 68 patients were infected in the U.S.

Manufacturer failure

The Committee determined that Olympus failed to issue safety alerts, despite knowledge of potential infection for years; that, Olympus and Fujifilm Medical Systems (Fujifilm) never applied for FDA clearance for their new device designs before selling them in the U.S.; and that Olympus, Fujifilm, and PENTAX attested that their cleaning instructions worked reliably, without sufficient data (see Cracking down: FDA sends warning letters to duodenoscope manufacturers, Health Law Daily, August 18, 2015). It concluded that the duodenoscope manufacturers, along with Custom Ultrasonics, the manufacturer of an automated cleaning machine used on duodenoscopes, “failed at every level to meet basic expectations of transparency and openness.” It further found that 16 U.S. hospitals affected were slow to report infections to various entities and did not follow all steps to report adverse events resulting from the devices to manufacturers and the FDA.


The Committee was most concerned about the length of the FDA’s investigation and its failure to take notice of existing studies from Europe that determined that the duodenoscopes could cause infections, even after adherence to cleaning instructions provided by the manufacturers. As a result, it recommended the creation and implementation of a robust medical device safety surveillance system, similar to the Sentinel system that allows the FDA to monitor drugs. Such a system would allow the FDA to access real-time information on adverse events, such as that included in insurance claims, without relying on manufacturers and hospitals to report them. It would also provide a larger pool of data so that the agency could analyze adverse events in the context of total patients treated.

The Committee specifically recommended that the FDA evaluate the design of closed-channel duodenoscopes and implement a phased recall; update guidance to specify when manufacturers should request 510(k) clearance after devices are modified; and implement new draft guidance to quickly provide providers with information when it becomes aware that a medical device might compromise patient safety. It recommended that Congress require that unique device identifiers (UDIs) be used in insurance claims, electronic health records, and device registries and clarify the FDA’s authority to consider 510(k) applications incomplete due to lack of sufficient data regarding whether a device can be safely cleaned and reused. Finally, it recommended that hospital compliance with adverse event reporting be made a condition of participation in Medicare.

Thousands of lives, billions of dollars saved by Affordable Care Act

The Affordable Care Act’s provisions to reduce hospital-acquired conditions (HACs) saved 87,000 lives and almost $20 billion in health care costs from 2010 to 2014, according to a report from HHS’ Agency for Healthcare Research and Quality (AHRQ). The report, Saving Lives & Saving Money: Hospital-Acquired Conditions Update, found that the four-year period saw 2.1 million fewer HACs—such as infections associated with catheters, central lines, and surgical sites—or a 17 percent decline. “Patients in America’s hospitals are safer today,” said HHS Secretary Sylvia Burwell.


Thousands of Americans die each year from preventable medical errors. HACs are conditions individuals acquire during the course of treatment for a different condition in a health care setting. Due to the high number of preventable deaths and injuries attributable to HACs, the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) included a number of provisions to reduce such problems. Under Section 3008, Medicare payments will be reduced by 1 percent to hospitals scoring in the top quartile of the national average for HACs. Section 3025 of the ACA also seeks to reduce hospital readmissions, which are associated with HACs, by reducing the base diagnosis-related group (DRG) payment to hospitals based on the ratio of actual to expected readmissions.

To implement the HAC reduction program, HHS created strong, diverse public-private partnerships and sought active engagement by patients and families. These efforts include the federal Partnership for Patients initiative, Hospital Engagement Networks, Quality Improvement Organizations, and many other public and private partners. According to HHS, public and private partners, including hospitals and other health care providers, are collaborating to identify and spread best practices and apply these solutions to reduce HACs and hospital readmissions.


The new AHRQ report shows that the HAC reduction program is accomplishing its goals of encouraging better care, smarter spending, and healthier people. An earlier report for 2010 through 2013 showed 50,000 fewer patients dying in hospitals and $12 billion in health care cost savings. After adding data from 2014, those numbers increased by 37,000 fewer deaths and $8 billion. HHS says that the updated data shows that the ACA’s patient safety improvements are holding steady, while showing an accumulation of impact over time.

To create the report, the AHRQ analyzed the incidence of a number of avoidable HACs compared to 2010 rates, using as a baseline estimates of deaths and excess health care costs that were developed when the Partnership for Patients was launched. CMS Deputy Administrator for Innovation and Quality and Chief Medical Officer Patrick Conway, M.D., said, “These results demonstrate that it’s possible to improve national patient safety performance resulting in millions of people avoiding infections and adverse events.” To assist providers in preventing HACs, the AHRQ produced a variety of tools and resources.