Sterilization-Related Challenges of Off-Site Transportation of Medical Equipment
By: Rodney Parker, Greg Baumgardner, and Susan G. Klacik
Categories: AAMI News, HTM Professionals, Medical Device Manufacturers, Sterilization Professionals
Medical devices and equipment increasingly are being transported from healthcare facilities to off-site locations for use or processing. The reasons for this transportation could include centralized processing centers being used to service off-site locations, a high-cost sterilizer located at one facility being used to sterilize items for several facilities, and/or healthcare facilities borrowing instrumentation and equipment (either on a scheduled basis or due to an emergency).
As these items are transported off site, maintaining their sterile integrity and proper functioning are concerns. Within a healthcare facility, the sterile storage environment is clean and monitored for temperature, humidity, and air flow. These factors are important because they affect the sterile integrity of a sterile package, as well as the functioning of medical devices and equipment. The environmental conditions of a sterile storage area are based on the standard ANSI/AAMI ST79:2017 & 2020 Amendments A1, A2, A3, A4 (Consolidated Text), Comprehensive guide to steam sterilization and sterility assurance in health care facilities, and the instructions for use from the manufacturer. While in the healthcare facility, the environmental conditions can be controlled and monitored; however, they may not be a consideration when transporting items from a healthcare facility, especially as a result of an emergency.
Challenges of Off-Site Transportation and Measures for Overcoming Them
Concerns related to off-site transportation may emerge. After a sterile item is transported away from the healthcare facility, it likely is exposed to uncontrolled environmental conditions that could cause damage or affect its sterile state. These uncontrolled conditions are present as an item is transported into and out of the healthcare facility and during its transportation. For example, if the transport vehicle is dirty, it could contaminate the item, and if the equipment is not secured, items could become dislodged, resulting in damage.
Medical device manufacturers test the transportation of their devices using standardized testing methods for the type of shipment required to move the product from the manufacturing plant to the end user. This often involves conditioning the shipping containers and devices to extremes in temperature and humidity, as well as shocks to the cartons from shaking and potential dropping of the shipping carton. This testing is done to ensure that a device reaches the healthcare facility in a condition that maintains its function for use.
|Product packaged for delivery by the manufacturer to the healthcare facility. Each item is placed in a separate box with restraining clear plastic retention and support cushion cardboard. Images courtesy of Stryker Instruments.|
Once at the facility, items are removed from the protective shipping cartons and placed into the system for processing and preparation for use. The packaging used at a healthcare facility is for sterilization (plastic peel pack, flat wrap, or sterilization container). Items are packaged as single items or in an instrument tray, an organizing set with holders, or a sterilization container. Of note, manufacturers do not test their devices outside of manufacturers’ shipping cartons in this manner to be transported over roadways to other facilities—unless this is a known requirement of the device’s use and is included in the device design requirements.
Rigid sterilization containers or organizing trays are designed to hold devices while undergoing sterilization processes. These same items are not designed to hold devices in a transportation truck to travel on roadways to another site. Use of these items may not protect the devices from shock and shaking to the same extent of that found with the original shipping carton. Medical devices are tested and challenged in numerous ways, and movement of them to other facilities may not immediately affect them during a few emergency transfers. However, frequent transfer—without the knowledge of the device manufacturer—may lead to functional or processing issues that may affect device use.
For example, a surgical power tool set with three tools, seven chucks, two collets, and an organizing case and tray is shipped to the healthcare facility in a total of 13 cardboard boxes that have been designed and tested for transport via truck or air shipment, in accordance with transportation standards. When they arrive at the healthcare facility, the cardboard cartons and internal packing material are removed and discarded. Those 12 medical devices that were shipped are placed in the tray and then the case and presented to the decontamination area for processing through the department. This configuration is tested to withstand the rigors of the processing for that equipment at the site; however, externally transporting it in this condition to another site, via truck or air vehicle, would lack the packaging as tested to withstand this type of transport.
The same holds true for the transport of flexible endoscopes. When flexible endoscopes are shipped from the manufacturer to the healthcare facility, they are packaged in tight-fitting foam, often in a suitcase type of container, to prevent breakage by holding them securely in place. This shipping case is kept in anticipation of future shipping of the endoscope (for instances such as repairs). Medical devices also may contain complex electronics, be fragile (e.g., microsurgical instruments), or have sharp edges that must be protected from becoming dull. Shipping of these types of devices without the appropriate packaging could damage the equipment, perhaps during the first instance in which it is transferred or after numerous transfers. The cause of damage may not be apparent to the manufacturer when sent for repair if the review of the external transport mechanism is not made known during the investigation.
Containers and organizing sets intended to be transported within a healthcare facility (e.g., between sterile processing and surgery) undergo a different type of transport testing. This testing is designed to mimic the conditions of healthcare facilities, which have controlled environments and fairly smooth-surfaced floors. In the previous example, the 12 items shipped to a healthcare facility in 13 boxes are placed into one organizing set and a container designed for sterilization, and this type of internal transport is considered as one unit. Devices within organized sets, such as k-wires, rongeurs, or cutters, could be delicate instruments with specific functions and sharpness requirements—requirements that would have been tested by the manufacturer under assumed normal use conditions. Unintended or undisclosed off-site transportation (over roadways) of these delicate items may limit the useful service of such devices if damage from this type of transport occurs.
|Full medical instruments sets as handled in the operating room and sterile processing areas. As with the products shown in the previous images, these products would have been shipped to the facility in approximately 13 separate cardboard shippers. Image courtesy of Stryker Instruments.|
As previously stated, device manufacturers are aware of intended distribution of items within a healthcare facility that has more standardized, controlled structures and environments; however, transfer or transportation of those same items to off-site locations, with or without the presence of a protective container or set with designated sections or bracketed positions, may not be the understood usage of a device and would not have been tested for such conditions. Off-site transfer of devices within uncontrolled transport vehicles has the potential to impart unintentional damage to a device that was not accounted for during the development process.
Communication and Setting Expectations
Consequently, communication becomes a key issue with the challenges of off-site transportation. If a healthcare facility does not have an internal sterile processing department (SPD) and understands that it needs to externally transport all devices for effective processing, this could directly affect the continued functionality or, potentially, cause damage to devices, depending on the shipping condition and awareness of the facility for transport care requirements. This is important information for the healthcare facility (as a customer) to share with device manufacturers to assess potential risks that might not have been addressed during product development. Continued communication between the healthcare customer and manufacturer could lead to scenarios where the healthcare facility that lacks an internal SPD conducts a risk assessment to determine the applicability of purchasing internal equipment for processing to avoid the burden and potential persistent damage to devices arising from external transportation.
Likewise, expectations of device transport to off-site locations are a key input for device manufacturers. Some configured sets (e.g., orthopedic instrument loaner sets) are easily identified and understood to be loaned equipment that travels over roadways to and from various facilities. For these sets, the device manufacturer designs the containment device to hold the set contents—following unboxing from original cartons and packaging—with brackets and holders for easier and safer transport. However, if the manufacturer sells sets of power tools or flexible endoscopes that were designed only with internal distribution within a single facility in mind, but the customer is shipping or transporting these devices to multiple off-site locations, this lack of communication and awareness could be detrimental to the continued use of those devices. Customer communication back to the manufacturer would aid the situation, allowing the manufacturer to proactively attempt to design a better system of transport and, potentially, a new containment device or case that could better hold and protect the equipment.
Shipping medical devices and equipment over roadways can negatively affect their functionality. This article has demonstrated how newly purchased medical devices are placed into packages that have been designed to protect them as they are shipped over roadways from the manufacturer to the healthcare facility. Once acquired by a healthcare facility, medical devices may only be shipped over roadways one time for an emergency situation or occasionally shipped over roadways. Conversely, some healthcare facilities use a centralized processing facility; this results in the continuous external roadway transportation of medical devices and could cause a device to be transferred over a thousand miles.
Healthcare facilities may transport medical devices off site using roadways for a variety of reasons, and it is prudent for the facilities to inform device manufacturers that their products are being shipped externally over roadways. The manufacturer may caution the facility that damage could occur to the item during transport. If the manufacturer is made aware, however, it may design a better containment system or even include external transportation as a design consideration.
As issues regarding processing medical devices continue to evolve, it is apparent that users (healthcare facilities) and device manufacturers need to communicate. At this time, many of the issues regarding external transportation of medical devices over roadways are unanswered. A new technical information report, AAMI TIR109, External transport of medical devices processed by health care facilities, is being developed by AAMI to address these issues. The content of this new TIR is based on collaboration among healthcare users, medical device manufacturers, and regulators to open conversations on these and other issues related to external transport—and to develop a method for healthcare facilities to transport medical devices safely and effectively over roadways.
Rodney Parker, PhD, is senior principal scientist at Stryker Instruments in Kalamazoo, MI. Email: email@example.com
Greg Baumgardner, MSc, is supervisor of sterilization and biocompatibility at Arthrex in Naples, FL. Email: firstname.lastname@example.org
Susan G. Klacik, BS, CRCST, CCSMC, FCS, ACE, is a clinical educator for the International Association of Healthcare Central Service Materiel Management; she is based in Chicago, IL. Email: email@example.com