Recently, the FDA conducted a surprise audit of Case Medical. The FDA has the right to do this whenever they want, to any FDA regulated facility, and give no notice beforehand. While conducting the audit, the FDA may ask for any information that they want, from whatever date they want, and it is up to the organization being audited to produce that information to show they are in compliance with FDA regulations...

Residue is material that remains after cleaning, like grease left over on a frying pan. It can also be a liquid residue that’s left over at the bottom of a bottle, pot, or can, and even moisture remaining at the base of a sterilization container or tray after sterilization. When it comes to removal of moisture in a container or sterilized tray this is easy to fix...

Yesterday we updated our signature block to reflect the beginning of a new decade in the life of Case Medical. Given all the projects we are working on and the upgrades with new equipment on the manufacturing floor, I nearly forgot that this week is our 31st anniversary...

Should, can, may, must… Healthcare is an industry that is highly regulated. And there are regulatory requirements that should be met for manufacturers and users, for the benefit of the patient. There are various products and processes available in sterile processing for the same intended purpose, whether it’s for decontamination, sterilization, or for surgical and patient care procedures. Where things get messy is when faced with conflicting messages...