EXPERIMENTATION TEST LOCATION: St. John’s Hospital, Maplewood, MN

EXPERIMENTATION EQUIPMENT: Steris-Amsco® Eagle 3000 60” Deep

EXPERIMENTATION OBJECTIVE:

Determine most appropriate or most challenging locations inside various Synthes® Instrument Set cases, Major Instrument and Bookwalter Retractor sets for the placement of internal chemical indicators. The purpose of this is to minimize the chance that these sets would be released when the sterilant (saturated steam) did not penetrate the most challenging areas.

EXPERIMENTATION CONCLUSION:

Created some failures, but were not able to determine precisely where the most challenging location was for placing the chemical indicators. Where the medical device manufacturer’s instruction is not available, a single chemical indicator in the center of the set is acceptable.

Only the medical device manufacturer can determine through validation testing (spore seeding, thermocouple use) where the most challenging areas are for placement of chemical indicators.

HEALTHEAST DECISION:

Reinstate chemical indicator monitoring program for instrument sets, packs and load. Meet best practice standards as established by the Association for the Advancement of Medical Instrumentation (AAMI), for accreditation reasons (JCAHO) and in the event of a legally required need situation. Implement change at the acute care hospitals, ambulatory surgery centers and office-based physician clinics.

HEALTHEAST ACTION:

Revise appropriate system policies. Develop system protocols for type and placement in set, package and load, retrieval and interpretation and action in the event of a non-responsive result. To be accomplished in the Fall 2005.

REPORT PREPARED BY:

Michael Festa

Director of Sterile Processing

HealthEast Care System

mfesta@healtheast.org

651.232.3106

* HealthEast finished documents will be available upon request