Solving the Unexpected Problem of the New USP 797 Sporicidal Disinfectant Requirement

Erin Higgins | August 18, 2023

After many delays, the revised USP General Chapter 797 providing guidance on sterile compounding will go into effect on November 1, 2023. While pharmacies have been aware of the update and preparing to meet it for some time now, one change is proving to have unexpectedly significant complications that must be addressed by cross-hospital teams....

Evaluating Waterborne Pathogen Risks for a Stronger Water Management Plan

Erin Higgins | April 21, 2022

Having an effective water management program has proven critical for minimizing patient exposure to a wide range of dangerous waterborne pathogens. In fact, one CDC study found that approximately 21% of HAIs can be transmitted via water. However, many hospitals have struggled with the development and implementation of a comprehensive water management program. Pathogens include...

Compliance with The Joint Commission’s New Water Management Standard Relies on Risk Assessment

Erin Higgins | September 13, 2021

Most healthcare facility managers already have in place a water management plan that outlines control measures for mitigating the risk of waterborne pathogens. Despite this, many of those same facility managers find themselves struggling with how to implement these plans in line with The Joint Commission’s (TJC) new water management program standard for the Hospital...

The Need to Understand Infection Risk Sources and Pathways to Mitigate HAIs

Erin Higgins | January 12, 2021

Hospital-acquired infections (HAI) remain a significant source of concern for healthcare facilities of all types and sizes, and the physical environment is often a leading source of these infection-causing pathogens. Data from the CDC indicates that each year, about 1 in 25 U.S. hospital patients are diagnosed with at least one infection related to hospital...

Beyond the Pharmacy: Preparing for Hospital-wide Compliance with USP 800

Erin Higgins | March 16, 2020

Over the past year, there’s been a lot of discussion about how hospital pharmacies can prepare for USP 800. While hazardous drug safety is not a new concern, the new regulations set forth in USP 800 will require most hospitals to make significant changes in order to achieve and maintain compliance. However, even though the...

Getting Ready for USP 800: What Your Hospital Pharmacy Needs to Know

Erin Higgins | December 10, 2019

While regulations for sterile compounding have been around for decades, many hospital pharmacies around the country have been racing to meet compliance with the new USP 800. Unlike the current standards set by USP 797, which are generally designed to protect the product, USP 800 aims to regulate employee protection. It provides requirements for healthcare...

Sterile Drug Compounding Contamination: What Facility Managers Need to Know and How to Maintain Compliance

Erin Higgins | December 2, 2019

The most widely publicized sterile drug compound contamination outbreak was traced back to the New England Compounding Center in 2012. This outbreak led to more than 800 cases and 64 deaths. The direct cause of these infections was fungal contamination of methylprednisolone that led to the development of fungal meningitis. Perhaps the most shocking detail...

5 Key Takeaways from the NEHES Panel Discussion USP 797/800: What You Need to Know

Erin Higgins | April 23, 2019

Recently I had the pleasure of moderating a panel discussion on the unique challenges of USP 797 and 800 compliance at the New England Healthcare Engineers’ Society (NEHES) Spring Seminar. With the compliance deadline for USP 800 looming (December 1, 2019) this is a critical issue for healthcare facilities. The panel included experts representing healthcare...