New Case Study: Surface Disinfection Incompatibility with Medical Devices Creates Potential Patient Risks

Post Author: HSI
September 30, 2021

The Healthcare Surfaces Institute (HSI) and the Association of Healthcare Value Analysis Professionals (AHVAP) announce the release of a first-of-its-kind case study featuring a real-world analysis of the risks and costs caused by surface disinfection incompatibility with medical devices in a patient care environment.

This in-depth case study identifies gaps and makes recommendations of multi-modal solutions to mitigate issues surrounding surface disinfection incompatibility and its risks to patient care.

HSI and AHVAP collaborated on developing this case study, wherein a large hospital purchased several hundred monitoring systems from a medical device company. Within two years, damage to the devices due to chemical exposure during the disinfection process was identified. The case study investigation focused on these issues:

  • The selection process used by the hospital for purchasing medical devices
  • Review of instructions for use (IFU’s) and testing data
  • Evaluation of manufacturer guidelines compared to hospital reprocessing guidelines
  • Examination of the guidance received by the medical device company when determining test method criteria for FDA 510(k) approval and follow-up testing
  • Calculation of both soft and hard costs incurred by the hospital and the medical device company

Both organizations evaluating this case study found that the ability to effectively reprocess medical devices by following a hospital’s infection prevention guidelines is critical.

“Surface disinfection incompatibility creates risks and costs the healthcare industry millions of dollars annually,” said Barbara Strain, MA, SM(ASCP), CVAHP, the Board Strategic Liaison for AHVAP. “It is important to align the decision-making process for onboarding medical devices with a risk mitigation mentality that addresses patients, staff, devices, and environment. If there is not a balanced approach, then the failure of one may cause all four to fail.”

Linda Lybert, the Executive Director of the Healthcare Surfaces Institute, found that “there is confusion, conflicting recommendations, and no minimum required testing and no validation standards to ensure surface materials can be effectively cleaned and disinfected. This case study provides insight into the many gaps that exist and what we must address.”

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