March 13, 2015 — The FDA has approved final guidance for manufacturers of medical scopes that have been linked to deadly outbreaks of infections because they are extremely difficult to sterilize.
Hospitals in Washington, California, Florida, Connecticut, North Carolina, and Illinois have all blamed the scopes on outbreaks of infection. Some of those outbreaks involved carbapenem-resistant Enterobacteriaceae, or CRE, an antibiotic-resistant bacteria that can be deadly in 50% of infections.
The FDA set out six criteria that manufacturers must include in the instructions for cleaning reusable medical scopes. The agency also asked for the following precautions:
- Provide clear and comprehensive cleaning instructions on the scope’s label.
- Test the effectiveness of the cleaning procedures and provide this data to the FDA.
- Consider designing the scopes in a way that facilitates cleaning.
According to the director of the FDA’s Center for Devices and Radiological Health, Dr. William Maisel:
“Patients and health care providers should know that the risk of acquiring an infection from a reprocessed medical device is low. … This guidance is an important step toward further enhancing the safety margin.”
Duodenoscopes are used in about 500,000 procedures every year in the United States. Last month, the FDA warned that the complex “elevator” mechanism at the tip of the scope, which is used to bend the scope into tight spaces, can be very difficult to sterilize effectively.
The FDA is reluctant to recall the scopes or require more stringent cleaning procedures, such as using ethylene-oxide gas, because they are used in emergency procedures, such as life-saving cancer biopsies.
Do I have a Hospital Infection Lawsuit?
The Schmidt Firm, PLLC is currently accepting duodenoscope induced injury cases in all 50 states. If you or somebody you know has been diagnosed with a “superbug” infection, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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