The Objective
Moving the cleaning and sterilization process to a centralized location outside of the facility of use calls into question the conditions that soiled and sterile instruments are being exposed to during transport . Not only are considerations needed for potential exposure to extreme temperatures and humidity , but additional consideration is needed to determine what levels of shock and vibration the instruments will experience during transport on public roads . Transporting soiled devices outside of the healthcare facility also consumes time before the instrumentation can undergo cleaning .
Within this study , a series of experiments were completed to understand how the environmental conditions of various transport vehicles affect the condition of sterile instrument trays .
Literature Review
The Association for the Advancement of Medical Instrumentation ( AAMI ) is in the process of releasing a Technical Information Report ( TIR ), TIR 109 , External transport of medical devices processed by health care facilities as guidance for providers who are transporting instruments on public roads , either from an off-site SPD or between two different acute-care locations .
Prior to the release plans of TIR109 , ASHRAE 170 was utilized where possible for guidance on the environmental conditions of Sterile Processing Departments . Regulatory bodies and stakeholder organizations – in drug and device , manufacturing and distribution organizations -- have long been working towards creating standards for temperature monitoring that ensure the shelf life , quality , and safety of products . In the past several years , mean kinetic temperature ( MKT ) has been identified as one of the potential tools available for evaluating the impact of temperature on product quality . The International Conference on Harmonization ( ICH ) stability testing guidelines define MKT as “ a single derived temperature , which , if maintained over a defined period , would afford the same thermal challenge to a pharmaceutical product as would have been experienced over a range of both higher and lower temperatures for an equivalent defined period .”
AAMI ST79:2017 section 11.3.5 Off-transportation gives extraordinarily little guidance on the topic . The section discusses that the vehicle be constructed of materials for ease of cleaning , separation of clean and contaminated items , and ease of loading and unloading .
It does spell out that the environmental conditions should be assessed while both in motion and not in motion . The standard does state that in geographical areas where there is high humidity is the norm that the user must do some testing and perform a risk assessment to determine the potential for items to be contaminated by becoming moist from any potential condensate . In addition , section 6.5.6 dives into the transport between buildings and offers a few more suggestions . Specifically ensuring temperature controls in transport vehicles .
Framework
Instrumentation samples utilized within this study were configured per ANSI / AAMI ST79 . Four factors were evaluated as part of this study to better understand the environmental conditions instruments could be exposed to during external transport . The factors are described below .
Vehicle Type and Device Placement
Since there are no suitable guidelines for the types of vehicles or device placement , three potential vehicles and placements were included as part of the study . Variations include :
• Environmentally Controlled ( EC ) Vehicle : Insulated vehicle utilizing HVAC while driving , instrument trays placed on shelving .
• SUV : Standard construct utilizing general air conditioning while driving , instrument trays placed in the back of the SUV .
• Passenger Vehicle : Standard construct utilizing general air conditioning while driving , instrument trays placed in hatchback area .
Temperature and Moisture
These two conditions were explored since hot temperatures , humidity , and dew point can affect soil chemistry and soil adhesion to the devices . In addition , these conditions can affect the sterility of the tray if exposed to extremes . Monitoring devices were placed within the trays to monitor temperature , humidity , and impacts . Additionally , outdoor conditions were recorded and pulled from online weather reporting sites . Set-up for data collection included :
• All vehicles being driven during the day and parked overnight .
• While vehicles were not running , they were parked inside garages or on the street with the parking location being recorded .
• Recordings ranged from 30 to 48 hours .
• The internet of things ( IoT ) wireless temperature and humidity monitoring devices were utilized for recording temperature and humidity during tests .
Routes
During evaluation of the environmental factors , all vehicles followed a mapped route with travel hazards noted to limit the number of factors that could lead to data differences between data sets not caused by one of the identified experiment factors . The IoT wireless temperature and impact monitoring device were utilized for recording temperature as well as shock during the routes .
Padding and Dust Covers
These two configuration modifications were explored during the study to determine if the additions could affect the data collected by the monitoring devices within the instrument trays .
• The IoT wireless temperature and humidity monitoring devices were utilized for recording temperature and humidity during tests .
• Clear dust cover was used to protect the contents from environmental factors such as moisture , dust , and lint during external transport .
Materials Materials utilized within the study are as follows :
• Instrument tray – orthopedic instrument trays within a rigid container
• Dust covers ( 8 ml protective plastic cover )
• Shelf padding 3 mil thick 1 / 8 inch
• Temperature monitoring device
• Humidity and temperature monitoring device
• Shock-monitoring device
• Environmentally Controlled ( EC ) Vehicle - Cargo van
• Personal vehicles
Methods
Mean Kinetic Temperature ( MKT ) is the primary tool for evaluating temperature excursions that fall outside of an established tolerance for a period of more than 24 hours . MKT addresses the stability of the environment for the tray inside its container .
This study investigates five environmental factors , two of which are regulated and three of which are not .
Regulated Parameters Temperature Instrument must be kept in an environment that does not exceed 75 degrees F ( 24 degrees C ). Humidity Instruments must be kept in an environment whose relative humidity is kept below 60 percent .
Non-Regulated Parameters Dew point In other situations where dew point is a focus , it is a common practice to pursue a dew point below 55 percent . Dew points between 55 and 65 are considered by many to be hot and sticky , while dew points above 65 percent are thought to be oppressive .
20 • www . healthcarehygienemagazine . com • april 2024