Letter from Olympus

Dear Healthcare Professionals, Patients and Family Members,

There has been continued media coverage regarding “superbug” bacterial infections in U.S. hospitals following procedures involving duodenoscopes. As the leading manufacturer of duodenoscopes, Olympus has been highlighted in some of this coverage. This letter reinforces Olympus’s highest priority of increasing patient safety and provides additional insights regarding the matter.

Internal Olympus documents were recently made publicly available in litigation. These documents show extensive efforts by Olympus personnel to seek to understand the causes of early reports in Europe of patient infections after a procedure with an Olympus duodenoscope. We recognize that, with the benefit of hindsight, it is possible to consider whether Olympus and others in the medical community should have made different choices at the time, especially with today’s knowledge about the emerging threat of multi-drug resistant organisms, such as Carbapenem-resistant Enterobacteriaceae (CRE).

At the time of these early reports, Olympus personnel acted according to the information available to them as the matter unfolded in real time, and they worked to determine the proper course of action. For example, Olympus submitted a medical device report in May 2012 notifying the Food and Drug Administration (FDA) that 16 patients contracted Pseudomonas aeruginosa (a multi-drug resistant microorganism) after a procedure with an Olympus device at a facility in Europe. Subsequently, customer notices in Europe were issued after consultation with the relevant European regulators and in connection with each jurisdiction’s specific regulatory requirements.

In the years since these first reports of infections, various investigative efforts by Olympus, hospitals, and government authorities have demonstrated that patient safety is a shared responsibility of duodenoscope manufacturers, hospitals and medical personnel, manufacturers of automated endoscope reprocessors, and regulators. Olympus has undertaken extensive efforts to investigate the causes of infections, improve and update duodenoscope instructions for use, communicate to the medical community the importance of thoroughly reprocessing devices according to the manufacturer’s instructions and offer further training on these instructions. There is undoubtedly more to be done, and Olympus continues to be focused on taking additional steps designed to improve patient safety.

Olympus duodenoscopes enable doctors to perform important, and often life-saving, diagnoses and treatments that would otherwise require significant abdominal surgery. More than 600,000 Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures are performed safely in the United States each year. Although any complication involving a patient’s health is serious and requires appropriate investigation, it is important to stress that the reported incidence of infection following a procedure remains extremely low.

Olympus contributes to society by making people's lives happier, safer and more fulfilling around the world. We take this matter very seriously and through our continued work with government authorities and other stakeholders, we are committed to identifying and addressing the root causes of the infections. We will update this page as information becomes available.

Sincerely,
Olympus America Inc.