As exam device turned deadly, its maker went silent. Where were regulators?

Twenty-one patients died and at least two dozen others fell ill from infections now linked to a flexible, state-of-the-art scope used in gastrointestinal examinations, even as the medical device’s manufacturer for years kept selling the instrument and failed to alert hospitals about growing dangers, the Los Angeles Times has reported. The paper detailed its findings about a nationwide outbreak that became public only after problems were publicized at a major, Southern California medical center.

The manufacturer, Olympus of Japan, blamed others and improper cleaning for deadly infections tied to its instrument. It also kept hospitals and regulators in the dark about problems with the devices, allowing each of several hospitals involved to think it was the only one having issues, the paper reported. It quoted a gastroenterologist at one affected hospital as saying the company’s silence was “unethical, irresponsible, and dangerous.”

Only after the Times published reports of three Southern California deaths did federal regulators issue a nationwide warning, and investigations in LA, Pittsburgh, and Seattle were tied together. These indicated that, what the manufacturer had called improvements in the scope’s design and had led to a higher costs for the devices, permitted a grimy film to develop in Olympus scopes; this residue harbored patient tissue and deadly microbes that were fatally spread. The company was brought in to see how hospitals tried to clean the scopes, offering no adverse commentary about intensified procedures that ultimately proved inadequate.

The Times also has posted a companion story describing Olympus’ woes with another of its scopes, this device to examine bronchial passages. As investigators discovered with these scopes, they, too, spread infections because their design hampered sterilization. Then, the company and its slow response prompted researchers from Johns Hopkins, an affected institution, to publish a 2003 letter to the New England Journal of Medicine, calling on manufacturers to accept the importance in device design of instrument cleaning to patient safety.

Such warnings apparently aren’t getting heeded as they need to be, as I’ve written before. I noted as recently as this fall that federal regulators had again issued extensive warnings to hospitals about hygiene, scopes, and other medical devices, particularly those that get re-used. Let’s also be clear: technology’s advances have created real challenges for experts in tracking and assessing safety issues as more new and redesigned devices roll out. The U.S. Government Accountability Office, a congressional watchdog, has put heightened oversight of medical devices as one of its “high risk” issues demanding urgent improvement.

As the Times stories make clear, however, fancy new hardware commands big dollars in health care. Lobbying of lawmakers by interests in this area are formidable. Further, it can be hard to create sufficient public clamor to prompt tough action by regulators and lawmakers because patients are affected piecemeal by many and different medical devices. News reporting in this area deserves credit for helping to clean up problems. It also may take concerted work in the civil justice system to hit bad actors with verdicts sizable enough to prompt more responsible action.