12/9/16

FDA Issues Guidance Regarding Gastrointestinal Scope Cross-Contamination


By on 6:34 AM

Issues with reprocessing of endoscopes continue to play a prominent role in the infection prevention arena. In late November, the U.S. Food and Drug Administration (FDA) issued guidance in response to ongoing reports of the possibility of cross-contamination from water bottles used for irrigation during endoscopy.

Concerns about contamination with blood, stool and other body fluids from the water bottles, particularly when irrigation channels lack a backflow prevention device, resulted in this guidance being published.

The FDA's guidance includes a recommendation for one or more device components within the irrigation system having some feature or backflow prevention valve to ensure safe use of the water bottles and proximal tubes or accessories. Quality control in the form of testing to ensure the prevention of backflow is also recommended. The FDA advises manufacturers to provide clear and specific instructions including labeling. Note: For additional coverage, see this Outpatient Surgery Magazine report.

Infection Control Consulting Services (ICCS), a national provider of infection prevention consulting, continues to stress the importance of following manufacturers' instructions, regulatory guidance and standards when reprocessing reusable devices.

ICCS works with gastroenterology and endoscopy centers throughout the country, providing oversight and assistance with reprocessing best practices, including onsite observation of processes and review of policies and procedures. If your organization requires assistance in this or any other area concerning infection control and prevention compliance and evidence-based practices, contact ICCS today.
 

Phenelle Segal, RN, CIC

Phenelle Segal, RN, CIC, FAPIC, is the founder and president of Infection Control Consulting Services LLC (ICCS). Phenelle has more than 30 years experience providing customized comprehensive infection control and prevention services to healthcare facilities nationwide. Her services focus on assisting hospitals, ambulatory surgery centers, dental office and oral surgery practices, doctor's offices, nursing homes and other organizations with implementing and maintaining an infection control program that: complies with The Joint Commission, AAAHC, Centers for Medicaid and Medicare Services (CMS) and other regulatory agencies; respond to situations of noncompliance; and improve the processes for reducing risk.

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