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March 13, 2012 

Wyoming Hospital Failed to Adequately Sterilize Equipment, Potentially Exposing Surgical Patients to Variety of Infections

In Letter, Public Citizen Calls on Wyoming Department of Health to Require Notification and Screening of Patients

WASHINGTON, D.C. – Several hundred patients undergoing surgery at a Wyoming hospital may have been exposed to a variety of infectious viral and bacterial agents over a period of several months because of insufficient sanitation procedures, Public Citizen said in a letter today to the Wyoming Department of Health.

Public Citizen recently learned from an internal hospital memo and other sources of information that in a November 2011 inspection at Wyoming’s Sheridan Memorial Hospital in Sheridan, the Wyoming Department of Health discovered that the hospital was no longer properly sterilizing or disinfecting reusable laryngeal mask airways (LMAs) between uses in patients undergoing surgery. At the conclusion of the inspection, the state agency required the hospital to immediately resume the appropriate sterilization method it had abandoned allegedly eight months earlier.

An LMA is a device inserted into a patient’s throat to provide anesthesia and mechanical ventilation for elective surgery. Because LMAs are in contact with mucous membranes in patients, the Centers for Disease Control and Prevention (CDC) requires that the devices receive a high level of disinfection. The manufacturer of the LMAs explicitly indicates that steam autoclaving – a process using steam under high pressure – is the only recommended method of sterilization for the devices. Sheridan Memorial Hospital allegedly only manually washed the LMAs with a brush, then conducted a low-level disinfection using an automated spray washer.

“The hospital’s decision to abandon steam sterilization was reckless and potentially dangerous for patients undergoing surgery at the hospital,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group.

In its letter to the Wyoming Department of Health, Public Citizen detailed three lines of evidence pointing to the recklessness of the hospital’s decision to abandon proper sterilization of LMA devices:

  • The substandard cleaning and low-level disinfection method temporarily adopted by the hospital was in clear violation of the federal CDC guidelines for sterilization and disinfection of such medical devices;
  • This cleaning and low-level disinfection method refuted the explicitly stated directions on the manufacturer’s label to steam-sterilize these LMA devices; and
  • Following its inspection, the Wyoming Department of Health ordered the hospital to revert to the previously used steam-sterilization procedure.

Approximately 100 patients a month undergo surgery using an LMA device at Sheridan Memorial Hospital, Public Citizen has been told. If this estimate is accurate, several hundred or more patients at the hospital may have been subjected to the inadequately sterilized devices, which could have exposed them to a variety of infectious viral and bacterial agents.

Public Citizen also is concerned that the hospital may not have taken the steps necessary to identify the cause for the inappropriate sterilization procedures and hold accountable hospital staff members responsible.

Public Citizen calls on the Wyoming Department of Health to require the Sheridan Memorial Hospital to inform patients about the possible exposure and risks, offer to screen patients for possible infections the exposure may have caused and treat any patients found to have been infected.

Some staff at the Sheridan Memorial Hospital allegedly were aware of, and concerned about, the failure to steam-sterilize the LMAs, but didn’t inform hospital leadership because of fears of retaliation, Public Citizen was told. If true, such an environment that stifles hospital staff from raising reasonable concerns about potential patient safety problems would more broadly represent a clear and present danger at the hospital, Carome said.

The Department of Health should require that the hospital implement policies and procedures that encourage staff to bring concerns about potential patient safety problems to the attention of hospital management without fear of retaliation.

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