America has entered a whole new phase of the COVID-19 pandemic. As of January 8, 2021, over 2 million U.S. citizens have been vaccinated with the Pfizer/BioNTech’s vaccine or with...

COVID-19 represents the single largest pandemic to hit the world in the past 100 years. By the end of October, 2020, the pandemic will have taken the lives of over...

PLYMOUTH MEETING, PA—“An analysis by the nation’s largest patient safety organization shows that up to 70 percent of KN95 masks it tested do not meet U.S. standards for effectiveness, raising...

Beginning in March of this year, the FDA has issued several Emergency Use Authorizations (EUAs) to help healthcare personnel and facilities in their fight against the COVID-19 epidemic. Over the...

Recently the FDA conducted a public advisory committee meeting to comment on the feasibility of various strategies to reduce (or completely eliminate) ethylene oxide (EtO) emissions from large-scale, medical device...

In Part I of this blog  we pointed out that “The #1 responsibility of everyone involved in reusable medical device processing is to minimize the risk of patient harm...

The #1 responsibility of everyone involved in reusable medical device processing is to minimize the risk of patient harm caused by a device that remains contaminated with organic debris after...

Over the past several years this blog has frequently addressed the many problems caused by contaminated duodenoscopes. According to a recent study, data from three major hospitals documented the fact...

In Part I of this blog we discussed the fact that several reusable device manufacturers claim that their cleaning and sterilization IFUs are ‘validated.’ We then raised two important...

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...