Farm’s very own Cheryl Kwinn, Senior Human Factors Engineer, was featured in the award-winning Horizons magazine, produced by the Association for the Advancement of Medical Instrumentation (AAMI). Published twice each year, Horizons provides in-depth coverage on a specific topic. The spring 2016 edition focused on the topic of Sterilization and Reprocessing: Overcoming Challenges, Safeguarding Patients.
Cheryl’s article, “Barriers to Adopting FDA Guidance in Central Sterile Departments,” discusses the issues surrounding reprocessing complex medical devices, a subject that has received recent attention as a result of “superbug” outbreaks traced to contaminated surgical instruments.
The barriers to adoption in healthcare facilities are many, including limited financial resources to implement the new FDA recommendations, no formalized requirements for technician training across institutions, and insufficient wall and counter space to hold the IFUs and wall charts required for each different complex instrument.
Although the FDA guidance puts much of the responsibility on the manufacturers of these complex instruments, implementing the manufacturers’ FDA-required safety measures and the FDA’s recent safety communication may require big changes on the part of healthcare institutions.