USP 797/800

On December 1, 2019, the US government health agencies mandated the use of Closed System Transfer Devices (CSTD) to protect healthworkers who work with hazardous drugs.

USP 800 is for bedside and administration, and USP 797 is for pharmacists.

The Q-FLO connector is fully compliant with both USP 797 and 800, giving you the ability to easily comply with these mandates to keep your healthworkers and your patients completely safe from exposure to hazardous drugs.

A Closer Look

Hazardous Drugs and USP <800> PDF

Safe Handling of Hazardous Drugs in Home Infusion PDF

FDA 510(k)

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification—also called PMN or 510(k).

​This allows the FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. This demonstrates that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device. 
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Having met the requirements for the FDA 510(k), the Q-FLO™ connector is indicated for the following: Use by healthcare professionals for connection with standard open female luers when reconstituting, dispensing/transferring, administering, and disposal of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, as well as non-hazardous fluids.

NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH (NIOSH)

NIOSH recommends healthcare workers use a Closed System Transfer Device (CSTD) throughout the hazardous drug-handling chain, from pharmaceutical compounding to patient dose administration.

As CSTD designs and available models changed, NIOSH and its industry partners realized the need for an independent testing method for CSTD performance.

While CSTD performance standards are available that apply to sterile practice and patient protection, no CSTD performance standards were available for drug containment. To address this gap, NIOSH researchers developed Air-Cleaning and Unified CSTD test protocols that evaluate a CSTD’s containment of hazardous drugs.

The Q-FLO™ connector is compliant with the NIOSH protocol, exhibiting superior test results compared to all other competitors.

White Paper

Click the image above to access the white paper.