In the world of healthcare, there's a currently prevailing issue that concerns healthcare policymakers, hospital administrators, and infection prevention professionals alike. Hospital-acquired infections, which are an ever-present danger for patients, pose a particular challenge to hospital administration as federal penalties are levied on hospitals with high rates of these infections.
The issue stares at a problematic…
Infection preventionists play an essential role in ensuring healthcare devices, specifically ultraviolet-C (UV-C) disinfection systems, adhere to relevant regulatory standards. As these systems become increasingly commonplace in hospitals as a response to the rise of healthcare-associated infections (HAIs), it's important for infection prevention and control professionals to have a clear understanding of the regulations that…
A constellation of regulations, standards, and protocols control the medical device production arena, among which the United States' Federal Drug Administration (FDA) and International Organization for Standardization's (ISO) stipulations play crucial roles. Specifically, the FDA's 21 CFR Part 820 and ISO 13485 commands extensive respect and observance due to their core focus on maintaining quality…
In an effort to enhance sterilization procedures and safety in healthcare, the Association for the Advancement of Medical Instrumentation (AAMI)/American National Standards Institute (ANSI) has recently issued an update to the ANSI/AAMI ST24 standard regarding ethylene oxide (EO) sterilizers. EO sterilization plays a pivotal role in preventing infection in medical settings due to its broad…