Abstract

A large midwestern hospital, with approximately 700 licensed beds and over 1.2 million patient encounters yearly, purchased several hundred state-of-the-art, non-invasive medical device monitoring systems. Within two years, there was visible damage to the monitoring systems, due to chemical exposure during the disinfection process.

Surface disinfectant compatibility is not a new issue to the healthcare industry. The goal of this case study is to find the problem’s root causes through deep dive real-world analysis.

Methods

The following investigational methods were used by the authors in this case study:

• Evaluate and understand the selection process used by the hospital for purchasing medical devices.
• Review instructions for use (IFU) and testing data compared to the hospital’s cleaning and disinfection process.
• Review test method criteria and disinfectant products used for FDA 510(k) approval and all follow-up testing.
• Calculate costs, both soft and hard costs, incurred by the hospital and the medical device company.

Authors

This case study was a joint educational collaborative effort by Healthcare Surfaces Institute (HSI) and Association of Healthcare Value Analysis Professionals (AHVAP) along with leadership of both organizations highlighted in the case study.