Hospital oversight lacking, experts say

Karen Bouffard, and Joel Kurth

Step inside the sterile processing facilities of multiple hospitals, and you’ll find variations in staffing levels, pay scale, education, management and culture that impact the safety of medical devices.

Loose control over the manufacture and cleaning of surgical instruments — and a lack of accountability by hospitals — increase patients’ risk of surgical infections, while making outbreaks difficult to detect and track, according to experts.

Hospitals largely police the quality of their own sterile processing operations, with only patchy oversight by state and federal agencies.

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Doctors and staff are expected to step forward when there’s an adverse event — such as a patient coming in contact with a dirty instrument — and to work openly to identify and resolve underlying causes through the peer review process, a scholarly method of self-assessment.

The federal Centers for Medicare & Medicaid Services requires hospitals to have an internal system for reporting risk or harm to patients. But the agency doesn’t verify that hospitals actually have such a system, or that it’s being used to report and correct problems.

Twenty-eight states including Illinois, Indiana, Ohio and Minnesota have passed laws that require hospitals to inform state officials of “adverse events” — such as when patients are harmed or die due to falls, medication mix-ups, surgical infections and other preventable causes. Twenty-two of those states make the data public, according to the National Academy for State Health Policy.

Hospitals in Michigan, and the remaining states, do not have to report medical mishaps to state health officials or the public. Participation in the federal Medicare program requires hospitals to provide data on hospital-acquired infections to the National Healthcare Safety Network, run by the CDC. The children’s hospitals don’t collect Medicare payments and provide no reports to the network.

No state requires that hospitals report exposures to dirty instruments, which may or may not lead to infection. As a result, it can be difficult to track whether patients become sick or die as a result. State reporting requirements, if they exist, typically are based on the National Quality Forum’s list of reportable events. That list includes contamination by drugs, devices or biologics, but only if the exposure results in serious injury or death.

“It’s a resource issue and it’s also a politically tense issue,” said Jill Rosenthal, senior program director at the National Academy for State Health Policy, when asked why states have resisted enacting such reporting requirements. “Often facilities don’t want to have to report, they tend to have strong lobbyists and some states haven’t been able to enact that kind of policy because of opposition.”

The safety of surgical instruments starts with the way instruments are designed and manufactured, experts said.

Deadly outbreaks in Houston, Los Angeles, Seattle, Pittsburgh and dozens of cities have been linked to superbugs that live in tiny bits of bone and tissue trapped deep inside hard-to-clean surgical devices. Even sterilized blood, bone or tissue — when deposited deep inside the body by a dirty surgical instrument — can trigger deadly conditions including sepsis or whole body organ failure due to the immune system’s response to the foreign matter.

Outbreaks have been linked to commonly used scopes used to see inside the body, tiny cannula that suck fluids away from surgical sites, and shavers that trim away bone and tissue during arthroscopic surgeries.

Jim Schneiter, a Chicago-based instrument designer, said the federal Food and Drug Administration didn’t go far enough last year when it instituted a rule that requires instrument manufacturers to “validate,” or prove, their devices can be cleaned using the manufacturers’ instructions. The rule isn’t retroactive, and scores of potentially deadly devices remain in use, Schneiter said.

Hospitals have invested tens of thousands of dollars in some devices and can be reluctant to replace them with new, easier-to-clean models, he added.

“All of these needless deaths could have been prevented if the FDA had demanded that all reusable medical device companies provide independent laboratory validation of their cleaning IFUs (Instructions for Use) before being given permission to sell their devices,” Schneiter said.

Chicago-based sterile processing consultant Donna Swenson said the FDA has “truly tried to address everything they were finding from the field.”

“The FDA does not have the authority to make laws retroactive,” Swenson said. “That would take an act of Congress.”

The Centers for Medicare & Medicaid Services requires that sterile processing facilities adhere to “industry standards” for the cleaning and sterilization of surgical instruments.

The accepted standards, experts said, are laid out in the American National Standard, published by the Association for Advancement of Medical Instrumentation. The Centers for Medicare & Medicaid publishes its own set of guidelines but adherence by hospitals is voluntary.

“A lot of people don’t seem to understand we have national standards in this country that you have to be compliant with,” said Swenson, who helps hospitals improve their sterile processing facilities. “A lot of people view them as recommendations which they don’t have to be compliant with — which is technically true, they’re not regulations ...

“They are voluntary but the expectation is that you are going to be compliant, and if you’re not adhering to a particular standard you better be adhering to a higher standard.”

Swenson recommends that hospitals audit their sterile processing departments at least annually — or more frequently in some cases. But audits also are voluntary, and not all hospitals conduct them.

The federal government uses private, nonprofit accrediting agencies to inspect hospitals and catch sterile processing errors. Those audits occur about once every three years.

In Michigan, about 90 percent of the state’s 150 hospitals with operating rooms are accredited — or given the seal of approval by accrediting agencies — and aren’t inspected by state auditors.

As a result, the state does about 10 on-site inspections per year of non-accredited hospitals, said Michael Loepp, spokesman for the state Department of Licensing and Regulatory Affairs, which conducts the inspections.