AAMI updates sterilization materials compatibility guidance
Editor's Note The Association for the Advancement of Medical Instrumentation (AAMI) has released the updated AAMI TIR17:2024; Compatibility of Materials Subject to Sterilization, its first revision since 2017. This guidance provides essential information for medical device manufacturers, designers, and sterilization professionals on how sterilization methods impact materials and packaging. Updates…
Mastering CMS regulations: How to ensure a finding-free Joint Commission survey
Takeaways • Requirements for improvement and condition level deficiency findings have been trending up in recent The Joint Commission surveys. • The scoring trends and OR hot spots focus on infection control, medication management, national patient safety goals, post-surgical electronic health record tracers, and transplant (tissue) safety. • Federal regulations,…
Practice updates ease steam sterilization balancing act
Reliable and robust enough for daily use on most medical devices, steam is the most common sterilant in healthcare facilities. However, using steam properly requires a balancing act. For example, too much moisture can lead to wet packs, while steam that is too dry might not be sufficient to achieve…
Updated AAMI standard addresses chemical sterilization safety, compliance
Editor's Note New guidance from The Association for the Advancement of Medical Instrumentation (AAMI) addresses regulatory and safety concerns for hospitals using ethylene oxide (EO) for medical device sterilization—a pressing concern due to EO’s effectiveness but associated health risks. ANSI/AAMI ST58:2024, an update on chemical sterilization and high-level disinfection practices…
Reprocessed medical devices save hospitals millions, cut emissions
Editor's Note In 2023, hospitals and surgical centers saved more than $465 million and prevented nearly 98 million pounds of greenhouse gas emissions by utilizing reprocessed single-use medical devices, according to a survey by the Association of Medical Device Reprocessors (AMDR). DotMed reported the news October 21. The data indicate…
Study: Preventing antibiotic-resistant infection surge could save millions
Editor's Note Research shows antibiotic-resistant infections could lead to 8.2 million deaths annually by 2050, representing a 75% increase from current rates, according to a September 17 article in HealthDay. Published in the Lancet, the new study highlights the growing threat of growing threat of antimicrobial resistance (AMR), predicting that…
Offsite sterilization fuels onsite efficiency for lean ASCs
For many in the healthcare industry, imagining surgery without onsite sterile processing seems unthinkable. Then again, performing total joints in an ambulatory surgery center (ASC) was unthinkable 10 years ago. ASC sterile processing departments (SPDs) are generally not designed to handle the high volumes of instrument trays, vendor trays, and…
Water quality: 5 Ws and an H for sterile processing pros
Asking who, what, why, when, where, and how—otherwise known as the “5 Ws and an H”— is a time-tested way for writers and researchers to ensure comprehensive coverage of any topic. Here, we apply this framework from the perspective of sterile processing department (SPD) professionals seeking to start a water…
AAMI updates guidelines on radiation sterilization validation, single-use systems control
Editor's Note In a new guidance document for manufacturers of pharmaceuticals and biopharmaceuticals, The Association for the Advancement of Medical Instrumentation (AAMI) has released a new guidance document updating best practices for radiation sterilization validation and routine control of single-use systems. The document, AAMI CR513:2024; Guidance on radiation sterilization validation and…
FDA announces Class 1 recalls of ventilator, eye injection kits
Editor's Note The US Food & Drug Administration has designated recalls of Baxter’s Life2000 Ventilator and the I-Pack Injection Kit from Bausch + Lomb and subsidiary Synergetics Inc. as Class 1, the most severe category indicating serious risk of injury or death. According to FDA’s July 15 announcement, the ventilator…
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