A recent report found blame to go around for a series of bacterial infection outbreaks linked to contaminated medical scopes, with regulators, hospitals and manufacturers all dropping the ball. Now new evidence indicates the problems with the scopes were apparent nearly four years ago, according to the Los Angeles Times, but major players in healthcare oppose a key feature that would prevent a delay in notification from happening again.
Contaminated scopes led to an outbreak at a Pennsylvania hospital in late 2012, but Food and Drug Administration (FDA) officials misplaced the paperwork before they could order removal of the devices from the market, the newspaper reported. The missing paperwork was not revealed until a recent Senate inquiry, further emphasizing the crossed wires, miscommunications and bureaucratic inefficiencies that exacerbated the more recent outbreaks, according to the article.
In all, at least 16 American hospitals experienced scope-related outbreaks without following proper procedures for reporting deaths or injuries related to medical devices, according to the Senate's January report. The FDA's initial 2013 investigation into scope-related outbreaks found that Olympus and another scope manufacturer sent the agency five outbreak reports, but the FDA turned up only one such report in its database, according to the newspaper. The agency took nearly a year and a half to warn hospitals of the problems with the cleaning protocols for the device.
A meaningful fix, meanwhile, may be easier said than done. The new system Senate investigators have called on regulators to implement has been in the works for years, but both the American Hospital Association (AHA) and Centers for Medicare & Medicaid Services officials have come out in opposition to it arguing the system would be cost-prohibitive, according to the article.
The proposal would reprogram hospitals' computers to record scopes' serial numbers, which George Arges of the AHA testified in 2014 was far beyond hospital billing systems' current capacity, according to the article. Then-CMS Administrator Marilyn Tavenner agreed, writing last year that the upgrade "would entail significant technological challenges, costs and risks to normal claims processing for Medicare and other payers," the newspaper reported.
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