Biofilm - When I was visiting with a client at one of his infant formula plants, I asked him what threat keeps him awake at night. Without hesitation, he said, "BIOFILM!"
Biofilm is incredibly resistant to removal and should never be found in areas where foods or drugs are produced or stored or where healthcare services are delivered. Identify it, Remove it, and Prevent its return.
Whether non-sterile or sterile, drug compounding is the vital last step in caring for patients with special needs. Access for patients to safe compounded drug preparations is vital.
I hate the expression, "there ought to be a law..." Legislation is always vague and insufficiently explicit and administrative law is always "one size fits all" loaded with unintended consequences that reduce creative options and limit liberty.
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We're moving past small molecule drugs and beyond even targeted biologics. Before long, we'll be delivering therapies that actually cure diseases.
Health professionals have abdicated their responsibility for establishing a verifiable State of Control to the people who "certify" their engineering controls.