FDA Announces Plans to Improve Medical Device Safety and Innovation The FDA recently proposed steps to improve the government's system for overseeing medical device safety and new product/device innovation. For...
FDA Rejects Push for New Regulatory Action on Medical Device Service Companies The FDA recently concluded that at the present time, there simply isn’t enough evidence to justify creating and...
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...
Nearly Three-Quarters Of Commonly Used Medical Scopes Tainted By Bacteria! Data from three major hospitals documented the fact that seventy-one percent (71%) of their reusable medical scopes deemed ready for...
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)...
FDA Alert: Risk of cross-contamination from 24-hour multi-patient use endoscope connectors to healthcare facilities performing gastrointestinal endoscopy procedures (April 18, 2018) The FDA is alerting healthcare providers and facilities about the...
What Does An Instrument Manufacturer Have To Do To Validate Their Cleaning IFUs? (Part III) In Part I of this blog post, we discussed the FDA’s mandate that all reusable medical...
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...
House Panel Probes Organizations That Accredit Most U.S. Hospitals The House Energy and Commerce Committee is investigating organizations that accredit most of the nation's hospitals following a report by The...
Breaking News: FDA Issues Warning Letters To Duodenoscope Manufacturers The U.S. Food and Drug Administration issued warning letters last week (March 9, 2018) to all three duodenoscope manufacturers for failing...
