Conceding that conventional duodenoscopes cannot be reliably reprocessed between patients, the Food and Drug Administration is recommending that manufacturers and providers move to disposable components for the intricate devices.
Congressman Ted W. Lieu (D-CA) has introduced two pieces of legislation after a yearlong investigation that he requested by the House Committee on Oversight and Government Reform found significant gaps in existing law that contributed to a nationwide problem of superbug outbreaks due to tainted duodenoscopes.
With all of the difficulties in cleaning duodenoscopes, and the potential for outbreaks of carbapenem-resistant Enterobacteriaceae, some outpatient surgery managers are questioning why these scopes are approved by the Food and Drug Administration. However, the benefits outweigh the risks, some sources say.
Responding to a series of outbreaks of carbapenem-resistant Enterobacteriaceae (CRE) linked to duodenoscopes, the Centers for Disease Control and Prevention has developed an interim protocol for culturing the devices before use to create a greater margin of safety for patients. But as others have noted, the approach is not foolproof and could be costly if facilities determine that they must purchase more scopes to adopt the protocol.