The most misunderstood and overlooked aspect of any reusable device manufacturer’s instructions for disinfecting, cleaning and sterilizing their product is whether those instructions for use (IFUs) have been ‘validated’ by...
In a previous blog we addressed issues surrounding the proper operation and maintenance of steam sterilizers, including the use of monitoring tools. These monitoring tools should include process challenge...
In Part I of this blog we pointed out that over the past 30 years, there has been a very significant increase in the number of outpatient surgical procedures....
Over the past 30 years, there has been a tremendous increase in the number of outpatient surgical procedures done in the United States. The number of outpatient procedures surpassed 54...
Can your hospital modify medical equipment or a surgical instrument that it purchased, paid for and legally owns? Can you modify or alter an instrument or piece of equipment to...
The problem of wet packs has been around since we first started using steam sterilizers to process reusable medical devices. It is imperative that you and your staff immediately take...
According to the CDC, over 30,000 patients die every year in the U.S. from a surgical infection. Among hospital acquired infections (HAIs), surgical site infections (SSIs) are associated with greater...
The FDA disclosed on Tuesday, August 20, 2019 that they had issued a warning letter on March 20th of this year. The warring letter expressed significant concerns by the FDA...
In Part I we reviewed the FDA’s latest Safety Communication on duodenoscopes that was issued on April 12, 2019. In that Safety Communication the FDA listed the patient infection...
