Category: Semicritical Devices

The Reprocessing of Sheathed “ENT” Endoscopes, Cystoscopes, and Other Types of Flexible Endoscopes

A number of years ago this blog’s founder – Dr. Lawrence F Muscarella – wrote the Food and Drug Administration (FDA) requesting the Agency review for clarity and consistency, among…

Recommendations for the Safe and Effective Use of Ortho-phthalaldehyde

This is the third of three articles by Lawrence F Muscarella, PhD, discusses the evolution of the labeling of a medical device – namely, of the “Instructions for Use” of…

ortho-phthalaldehyde: A Tale of Three Labels

May 6, 2013 (revised 12-23-2014) — This article discusses the evolution of the labeling of a medical device — namely, of the “Instructions for Use” of Cidex OPA, which is…