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USP 797, Pain Pumps and You

With the induction of United States Pharmacopeia (USP) 797 sterile compounding guidelines in 2008, many rigid regulations of the compounding processes for ambulatory peripheral nerve blocks have been developed. USP 797 requirements are strictly outlined, above and beyond non-sterile compounding and good compounding practices. The sterility of the compounds must be tested and validated throughout the meticulous process. A pharmacy / facility compounding sterile preparations (CSP) will need to control and maintain the environment, personnel, and processes for aseptic techniques; especially, for CSPs that will be infused into the vascular and central nervous systems of the patients. Since ambulatory peripheral nerve blocks are aqueous solutions that enter the body and can pose a significant risk to the health of a patient, pharmacies / facilities compounding sterile preparations must implement written Standard Operating Procedures (SOP) through extensive education and training programs

The main difficulty ambulatory peripheral nerve blocks pose to pharmacies / facilities is the SOPs for filling the device within USP 797 regulations. One must create additional steps and procedures specific to that particular device. These procedures must be checked and rechecked periodically to validate the effectiveness of the current SOP and the ability of the personnel to comply fully with USP 797. Manufactures have developed SOPs specific to there very own devices to help assist facilities with this difficulty but even when following extensive manufacture guidelines for compounding sterile preparations in an ISO Class 5 or better laminar flow bench some devices are classified as medium risk.

An additional struggle for pharmacies / facilities is the extensive time consuming processes involved with filling an ambulatory peripheral nerve block. To increase efficiency, pharmacies prepare multiple infusion devices at a time to build a supply that is stored to meet daily demands. This alternative leads to additional validation testing of sterility, possible waste of product, and possible waste of expired CSPs that cannot be stored in infusion devices and still maintain complete compliance to USP 797.

There is an ambulatory peripheral nerve block device on the market that allows pharmacies / facilities to eliminate the difficulties above. The ambIT PCA by Sorenson Medical does not interrupt or increase the number or complexity of the processes or procedures for USP 797 compliance. The unique ability of the ambIT cassette to connect to any standard bag via spike or luer connection allows for a seamless introduction of the ambIT Infusion Pump System into any pharmacy / facility compounding sterile preparations. No additional SOPs need to be produced for the ambIT PCA, thus, eliminating any possibility of additional liability, and maintaining the integrity of the pharmacy’s implemented SOPs that are in compliance with USP 797. Since a standard bag is filled without open air access to medication the risk of contamination is low when filled under an ISO Class 5 or better laminar flow bench.

Since the ambIT Infusion Pump System utilizes a standard bag there is no need to prepare multiple CSPs prior to one being ordered. This allows pharmacies / facilities to maintain complete compliance with USP 797 and cuts down on wasted CSPs and product.

By reducing the complexity of compounding medications for peripheral nerve blocks a pharmacy / facility is improving the compounding of sterile products, reducing or preventing harm to patients, reducing microbial contamination and reducing compounding errors.

For more information, please contact the team at OR Dynamics.