Exception to the rule – transporting medical devices10 April 2014
In January 2013, a new clause governing the international transport of used medical devices came into force, offering used medical device shippers a more tailored means to transport their goods. But what does the clause mean in practice, and will it actually benefit shippers? David Creighton, regulatory and training manager for Saf-T-Pak, explains all.
Updated regulations governing the international transportation of dangerous goods (or hazardous materials) came into effect in January 2013, and these regulations include a new exception for shipments involving medical devices that have been used or contaminated and then need to be shipped to another destination. This new clause is referred to as the 'used medical device exception'.
According to the Recommendations for the Transport of Dangerous Goods Model Regulations published by the United Nations (UN), a used medical device (UMD) is a device or apparatus that has been contaminated through contact with a patient (human or animal) that then needs to be transported for disinfection, cleaning, sterilisation, repair or equipment evaluation.
According to the pre-2013 regulations, any device or equipment that had been in direct contact with a patient was classified as a patient specimen. All patient specimen shipments are governed by the transport regulations, as they pose a potential risk to the health of individuals who might come into contact with the specimen through potential pathogens. Historically, when the patient's medical history was unavailable, these shipments were classified as Category B infectious substances. With the introduction of the new exception, there is now an alternative way to ship UMDs.
This addition to the regulations is not mandatory. Many UMD shippers are accustomed to shipping devices as Category B infectious substances, and these shippers have existing protocols or standard operating procedures that they prefer not to change. Although these shipments may now qualify for this new exception, it is still acceptable for UMD shippers to continue shipping these devices as Category B infectious substances. Either method is satisfactory; however, the new exception offers the shipper an alternative method of preparing their shipments.
The shipping forecast
The regulations that govern shipments of dangerous goods, including UMDs, outline very specific regulatory requirements or the preparation and shipping of biological specimens, including packaging, marking, labelling and documentation. On the other hand, within these same regulations, there are a number of unique shipments that can be excepted.
When a shipment is excepted from the dangerous goods transport regulations, it no longer requires compliance with the regulatory requirements to ship dangerous goods. However, in order to qualify for the exception, certain criteria must be met.
Generally, the criteria for an exception are less stringent than for non-excepted shipments, and this is the case with the UMD exception. Although there are some transportation requirements for UMDs to be shipped, these are more relaxed than those for shipping a Category B infectious substance. For example, under the new dangerous goods transportation exception, UMDs can only be shipped for the purpose of disinfection, cleaning, sterilisation, repair or equipment evaluation. If the device is being shipped as a waste product, the exception does not apply, and it must be shipped as regulated medical waste.
Additionally, if the UMD could potentially contain a pathogen meeting the classification criteria for a Category A infectious substance, it must be shipped as one. Category A infectious substances found in patient specimens are those pathogens that are considered high-risk, deadly pathogens. Some examples include the Ebola, Variola, Hantaan, Lassa, Omsk haemorrhagic fever and other haemorrhagic fever viruses.
Another limitation of this UMD exception would be if the device contains an additional substance that is considered a dangerous good - for example, preserving or neutralising agents (including formaldehyde) or various alcohol solutions.
If these substances are contained within the device, the shipment must be prepared according to the requirements stipulated for shipping these other dangerous goods. When a preservative or a neutralising agent is used to inactivate a pathogen, the UMD exception may not apply, as the UMD exception is intended to remove or limit the potential for any individual who may come into contact with the package from a risk of infections or disease that may be caused by pathogens in the sample.
When a pathogen has been neutralised, it is no longer able to cause disease. Consequently, the shipment may not be subject to the UMD exception. If the decision of the shipper is that the pathogens can no longer cause disease in humans or animals, the shipment would need to be classified according to the nature and risks associated with the preservative.
If the limitations listed above are not applicable to shipment of a UMD, then the shipment can be prepared according to the UMD exception. Keep in mind, however, that any package containing a UMD to be shipped under this exception must meet certain minimum requirements. For example, it must be constructed so that it cannot be punctured, leak its contents or break under conditions normally experienced by a package during transport. Examples of these conditions include vibrations, weather (rain/snow), loading (shocks/bumps), stacking, mechanical handling and changes to temperature, humidity or pressure (including altitude changes during air transport). Additionally, the packaging must be of good quality and in good condition.
Package reuse is permitted, provided the package is still in good condition. However, if the package has been damaged or is in poor repair, it must not be used to ship a UMD. Because the package must be closed in such a manner as to ensure it will remain closed during transport, it must also be designed so that its closure is easily understood by the person who is preparing the shipment.
In addition to the normal conditions a package may encounter during transportation, the new exemption requires a package containing a UMD to be capable of retaining the medical device when it is dropped from a height of 1.2m. Before a drop test is performed, the package manufacturer will develop a package design, and this outlines all of the steps and materials used to prepare a package for the drop test. When the design is tested and subsequently passes, any package prepared in the same manner as the test sample will also be capable of passing the test.
In order to ensure packages are prepared according to the tested design, the individuals or companies performing the test must prepare instructions. These instructions must detail all of the steps and materials used in the tested package design. This will ensure that any package prepared according to the instructions will be able to pass the required drop test. Any alterations that are not part of the instructions will result in a new package design, and, should this happen, this must also be tested.
A key component of the package design for UMDs is the final layer, referred to as the outer packaging. For the shipment of dangerous goods, outer packaging is limited to certain materials and shapes.
For UMDs, the outer packaging may be a fibreboard, plastic, plywood, natural or reconstituted wood, or metal (including steel and aluminium) box, or a steel, aluminium or other metal, plywood, fibre or plastic drum.
Although these materials and shapes are permitted, there are specifications for the materials in each before they can be used. For example, an approved fibreboard box must be double-faced and corrugated (either single or multiwall), and also water-resistant, in accordance with the Cobb method of water absorption as outlined in ISO 535:1991.
Additionally, a fibreboard box must be cut so that cracking, surface breaks and undue bending will not occur during package assembly. A fibreboard box must meet all the previously listed requirements before it is permitted to be used as outer packaging for a UMD shipment under this new exemption.
Package marking is another element of UMD packaging design, as markings are used by the transport industry as a form of communication for anyone coming into contact with the package. These markings convey the nature and risks of the materials or substances inside the package and can help direct the emergency response in the case of an accidental spill or leak.
Although a minor marking, the outside of a UMD package under the new exemption must be marked with either 'used medical device' or 'used medical equipment'. This marking is not required to be pre-printed on the package, but it must be durable, clearly visible and in a location where it will not be obscured. For this reason, marking the bottom of the package is not permitted.
Although package marking is mandatory, no documentation requirements are defined for a UMD shipment. Consequently, under the new exemption, when a UMD package is prepared and marked for shipment, no documentation is required.
Even with the new exception, some medical device companies have chosen to simply continue shipping their UMDs as Category B infectious substances. Often, Category B packages are already designed and incorporated in their standard operating procedures or protocols, and since a Category B package is more robust and passes the drop test, they do not see the need to alter their practices. Similar to many engineering design modifications, these companies have opted to forgo the minimum design standards in favour of a more robust package design.
It is important to keep in mind that, although this new exception to the regulations was published in January 2013, additional changes and requirements may still occur, as there are a number of ongoing debates taking place during the UN Dangerous Goods meetings with the intent to alter some of the requirements.
A key concern is the drop test requirement, which may not be physically possible or financially viable when the UMD is a very large and/or expensive piece of equipment.
There are also concerns that some UMDs may have the ability to puncture the packaging, and the current exception does not address the need for puncture-resistant materials. As no conclusions have yet been reached with regard to these additional concerns, it is a good idea to monitor any upcoming regulatory changes as they continue to evolve.