Baystate Health

Michael D. Gudejko

Flexible endoscope reprocessing and tracking is critical for patient safety because of reprocessing challenges, variables, and patient risk. Endoscopes are flexible medical devices that allow the practitioner to look inside a patient. Some examples of flexible endoscopes are colonoscopes, bronchoscopes and gastroscopes, which include a fiber optic system to view inside the colon, the lower respiratory tract or the stomach. These flexible endoscopes cannot be sterilized at high temperature therefore endoscopes are reprocessed with a high-level disinfectant, a chemical germicide which can destroy viruses, vegetative bacteria, fungus, mycobacterium, and some bacterial spores.

In recent years there have been several accounts of incomplete or inappropriate cleaning of endoscopes resulting in look backs and patient notifications. FDA reported over 400 patients contracted serious infections from bacteria tainted endoscopes between January 2010 and October 2015. Some of these incidents have resulted in patient harm and lawsuits. Pro-actively our facility performed a root cause analysis and corrective action plan that included a process improvement plan for reprocessing training and competency assessment. The current patient documentation paper trail did allow easy traceability. We believed technology could improve patient safety. The initial problem statement included the following issues and pain points. Flexible endoscopes are used in the Operating Rooms (ORs), in outpatient areas, in the Emergency Department and in the Intensive Care Units. Our facility has approximately 55 different endoscope models that must be manually reprocessed, this requires competent staff who must demonstrate proficiency in the cleaning and reprocessing procedures. Paper documents are attached to each scope with processing information and reprocessing expiration date. Data from the current instrument tracking application recorded date and time of reprocessing demonstrated that scope reprocessing, utilization and repair needed process improvement.

Sterile Processing Department (SPD) initiated process improvements to gain control by centralizing scope reprocessing, selected and validated scope processing staff education and redesigned the work flow for endoscopes. After a demonstration of an instrument tracking software with Radio Frequency Identification (RFID) technology, we challenged the vendor to provide the same level of detail for endoscope tracking. Our current technology was dependent on staff manually scanning, but RFID scanning would be passive scanning and drastically reduce human error.We partnered with the vendor to design an innovative product to focus on patient and staff safety.

We agreed on a phased approach to our problem. The first phase was to control the reprocessing process with step by step instruction according to the manufacturer’s instructions for use (IFUs). In these processing steps would be timers, for example soaking and brushing times. The electronic competency would be a hard stop for processing each scope by type and model number. If staff does not have system approval, they cannot reprocess that scope model.

The new scope processing room was redesigned for a unidirectional work flow from dirty to clean. The application installation allowed for washing stations with touch screen monitors. A cleaning validation station is utilized for lumen clean confirmation using chemical (channel check) as well as visual aids (borescope). The check of the highlevel disinfection (HLD) chemical minimum required concentration before placing scope in the automated endoscope reprocessing (AER) device. The AER devices include documentation for HLD traceability. The next scope tech will review the reprocessing parameters for acceptance criteria, validate and scan the receipt into the software. Lastly the packaged scope is scanned to their “home” cabinet destination.

The second phase is Scope Safety storage cabinets. These RFID cabinets secure the scopes for storage. If a scope scanned to the cabinet does not have a reprocessing record, the cabinet will not open or allow it to be stored inside. The RFID tag attached to each scope uniquely identifies the scope location as well as contains the reprocessing history and validation. The design is to know what scopes are available for patient use in three different storage locations. A total of twelve cabinets were installed, four for inpatient ORs, three inpatient Endoscopy and five for outpatient Endoscopy. The design consists of one PC controlling a bank of cabinets with a staff badge scanner for accessibility. The personal computer is on the hospital network making updates and database connection easier for Information Technology department to manage. There is a camera to take a picture of anyone who removes a scope emergently not using the standard badge scan access process. This allows scopes to be accessible for emergent procedures while adding in accountability. The cabinet will distribute scopes on a first-in first-out basis while also taking expirations into account.

The third phase is to provide real time locating service (RTLS). Our facility is in the process of migrating adated application for equipment tracking to a new application. We plan to work with our vendor and the equipment tracking vendor for real time scope location.

This innovative project has been a collaboration between our healthcare facility and a new vendor which would not have been possible with out the support of leadership team and cross-departmental collaboration. The application of technology and a “smart” system has drastically improved patient safety by reducing human error while reducing wear and tear on equipment inventory.