Attribute: Is Sterile
The Is Sterile attribute is important in Data Connect because it helps providers ensure that they're using products that meet necessary sterility standards, which is crucial for patient safety. Sterile products are essential in medical settings to prevent infections and complications during medical procedures, particularly in surgeries and other invasive treatments.
By accurately identifying and managing the sterility status of products, Data Connect helps healthcare facilities make informed purchasing decisions, comply with regulatory requirements, and maintain high standards of patient care.
Data Sources
Here are the sources of data for Is Sterile:
Primary Source
FDA's AccessGUDID.
Alternate Sources
Manufacturer catalog (when not available in GUDID).
Standardization
Is Sterile is standardized based on the accuracy of GUDID-submitted data.
Considerations
The FDA defines sterile as a product that is free from viable microorganisms. The sterilization process must meet specific standards and validations to ensure the absence of living organisms.
Manufacturers are required to publish this information to the FDA, but this isn't enforced. GHX provides a pass-through from the FDA when available and also sources this information from the manufacturers directly.