A Road Map to Off-Site Sterilization

Surgical tools (Adobe Stock 18026114 by Dmitry Rukhlenko)

Instrument reprocessing off-site from the facility of use is a concept that has been previously introduced. Many hospital central processing departments (CPDs) sterilize instruments for ambulatory procedural areas under the hospital’s license. Recently, this concept has evolved into off-site sterilization facilities that reprocess instruments for hospitals. Large health care systems often own and operate these facilities and provide service to multiple hospital entities within the system or may be contracted to a third-party off-site sterilization provider. 

Off-site sterilization offers the benefit of additional real estate in the acute care setting. The return on investment (ROI) is realized with the additional hospital capacity for patient beds, procedural areas, and services. For example, some hospital CPDs are located adjacent to the operating rooms (ORs), and relocation of sterilization off site provides the opportunity to expand existing ORs for specialized procedures that require a more significant footprint or add additional ORs. A new hospital building with additional patient beds increases the demand for ORs and other procedural areas. Subsequently, increased volume of reusable medical instruments adds dimension to the proposal for an off-site sterilization plan.

Off-site sterilization offers the benefit of additional real estate in the acute care setting. The return on investment (ROI) is realized with the additional hospital capacity for patient beds, procedural areas, and services.

Real estate conservation is only one aspect of ROI. Consolidation of services also offers the opportunity to decrease labor costs while employing highly trained staff to ensure the product has been properly processed and is safe for patient use. Standardization of instrument sets, processes, and equipment decreases the risk of surgical site infections, resulting in revenue loss in terms of increased length of stay, readmission, and reimbursement from payers.

The planning stage begins with a high-level process map (or value chain map), then core processes and goals are identified. Key stakeholders at this stage include senior leadership, and this mapping may be part of the business plan proposal, which outlines the ROI. Once the decision is made to move forward with off-site sterilization, a more detailed process map defines the decision points based on the input and output of expected steps.¹ Engaging an infection preventionist (IP) who is certified in infection control in this detailed mapping is essential to the project’s quality and success. 

Assessment of needs is critical in the early planning stages with surgeon engagement. This begins with a current inventory and integrity of surgical sets, single instruments, and instrument manufacturer instructions for use (IFUs). The input of these process data will vary from the output, as outdated instruments lacking IFUs or compromised integrity shall be discarded from inventory. Anticipated surgical volume and types of procedures also impact the output data and are inherent to the detailed map. The goal is to standardize instrument sets to ensure capacities for sterilization cycles. Future projections should be incorporated into a designated time frame encompassing the near future. Five years may be a good starting point for this projection, as new procedures and instruments must be anticipated.

Another detail to be explored in this process map is what volume of sterilization services shall remain on-site and for what instruments. Keeping some sterilization and instrument inventory on-site in an emergency or disaster that precludes transport is essential. A “just-in-time” inventory management model may be used for single instruments for scheduled cases that are reprocessed on-site.

Transportation of instruments requires detailed inputs and outputs to identify variables, both anticipated and unanticipated. The Department of Transportation and states Department of Health regulations provide data inputs to the process design. Tracking instrument sets and air quality of temperature and humidity at holding stages adjacent to loading docks and during transport can be managed with electronic documentation. Variances in environmental conditions are unavoidable, as case carts are exposed to outside conditions²with loading dock and vehicle doors opening and closing. The IP can conduct a risk assessment for variances with a time threshold for any parameter that deviates from air quality standards for instrument handling during the transport and case cart holding stages. This assessment should be detailed as output data in the process map and embedded into subsequent policies and procedures.

The detailed process map should also include instrument tracking. This is conducted using an electronic scanning system to scan the instrument to the patient and, through transport, to scan into decontamination, sterilizer, and then to the case cart for transport back to clean storage in the hospital.

Instrument case carts built with the instrument sets and required soft goods for a surgical case may bypass clean storage and be taken directly outside the OR, where contents are unloaded and placed in the OR for the scheduled case per the just-in-time operations model.

Case carts must have a clean identifier on the outside, which is then changed to biohazard identification after the case when soiled instruments are loaded into it. Instruments must be precleaned at the point of use and sprayed with an enzymatic spray or another wetting agent to keep instruments moist until full decontamination occurs at the off-site reprocessing facility. The IP will review the proposed input processes data and make recommendations to the output data as needed to ensure compliance with the CDC’s Guideline for Disinfection and Sterilization in Healthcare Facilities³and the Association for the Advancement of Medical Instrumentation (AAMI) standards.

The architectural team draws up the design of the instrument processing facility. The IP reviews these plans to ensure the separation of clean and dirty. Heating, ventilation, and air conditioning should be assessed to comply with the American Society of Heating, Refrigerating, and Air-Conditioning Engineers and CDC requirements of directional airflow from clean to dirty and the associated differential air pressures, temperature, and humidity.⁴ Both decontamination and sterilization should have dedicated anterooms to maintain the differential airflow. Water management is also a critical assessment for the IP to ensure that AAMI standards for critical water and steam are achieved. Additional checks include directional instrument flow process from dirty to clean, including separate loading docks for each and placement of handwashing and eyewash stations. A vendor room for delivering instrument sets is best designed adjacent to the decontamination area with a pass-through chamber that prevents disruption of airflows. A separate clean room for loaner sterile instrument sets should be created the same way adjacent to the sterilization area so that cross-contamination does not occur.

The IP role also expands to employee safety. One example is a selection of personal protective equipment by assessing the ASTM rating of masks and AAMI level for gowns for fluid penetration. In addition, IPs can be instrumental in policy development that references instrument processing guidelines and standards, environmental controls, and employee safety. The expertise of IPs bridges the gap between a rogue process map and evidence-based practices that will withstand regulatory surveys. The assessment skills of IPs apply to selecting a third-party vendor for off-site sterilization, should this option be chosen.

Although the details of a process map and design for off-site sterilization should be narrower to meet the confines of this article, they can easily be further researched by the interested reader.

References

1. Discover the power of visual process mapping with our comprehensive guide. Creately. Updated December 11, 2022. Accessed March 24, 2023. https://creately.com/guides/process-mapping-guide/

2. Parker R, Baumgardner G, Klacik SG. Sterilization-related challenges of off-site transportation of medical equipment. Association for the Advancement of Medical Instrumentation. June 2, 2021. Accessed March 30, 2023. https://array.aami.org/content/news/sterilization-related-challenges-off-site-transportation-medical-equipment

3. Appendix B. Air. Guidelines for Environmental Infection Control in Health-Care Facilities (2003). CDC. Reviewed July 22, 2019. Accessed March 23, 2023. https://www.cdc.gov/infectioncontrol/guidelines/environmental/appendix/air.html

4. Disinfection and sterilization. CDC. Reviewed May 24, 2019. Accessed March 24, 2023. https://www.cdc.gov/infectioncontrol/guidelines/disinfection/index.html