
Q: Recently, I refused to process a device based on the following manufacturer’s instructions provided: “The xxx parts are made of durable aluminum and can be cleaned with ultrasound and any cleaning agents. Any standard sterilization technique is acceptable. There are no moving parts to maintain.” I contacted the company to alert them the instructions for use (IFUs) were insufficient. The company replied that “reprocessing is a different concept from cleaning and sterilizing a simple instrument for reuse.” They stated that the particular instrument in question “is a simple "instrument" like a retractor or a mallet. These instruments are reused; do not have critical "parts" that need to be retested between uses. They need to be cleaned and sterilized. It is a simple device with no moving parts or cavities or other complicating factors. How does one handle this?











