Cleaning Validation

The Continuing Call For Validated IFUs In a new article in Healthcare Purchasing News, noted author and reprocessing expert Rose Seavey said that “Many reusable devices pose great...

What About Loaner Instruments & Items That Do Not Have An IFU?(Part II) In Part I of this blog post we began looking into the problems and issues that occur...

What About Loaner Instruments and Items That Do Not Have IFU? In 2018 the FDA approved more 510(k) submissions for new medical devices than in any previous year.1 A significant...

Draft of New AAMI Validation Requirements The FDA first published “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration” on...

Manufacturer Validation of Cleaning IFUs? (Part VI) In Part I of this blog, we discussed the FDA’s mandate issued on March 17, 2015, that all reusable medical...

What Does An Instrument Manufacturer Have To Do To Validate Their Cleaning IFUs? (Part V) In Part I of this blog series, we discussed the FDA’s mandate that all reusable...

What Does An Instrument Manufacturer Have To Do To Validate Their Cleaning IFUs? (Part IV) In Part I of this blog series we discussed the FDA’s mandate that all reusable medical...

Hospital Forced To Cancel Surgeries For A Week Due to Contaminated Instruments On May 10, 2018, a hospital in Denver, Colorado, cancelled all surgeries for a week due to contaminated surgical...

Novo Surgical’s Educational Program at IAHCSMM’s National Meeting “Visual Inspection" vs. "Validated IFUs" : An ‘Invisible’ Patient Safety Issue This past week the International Association Healthcare Central Service Material Management (IAHCSMM)...

What Does An Instrument Manufacturer Have To Do To Validate Their Cleaning IFUs? (Part II) In the first part of this blog (March 16, 2018), it was pointed out that...