Exception to the rule: shipping used medical devices29 September 2013
Regulatory expert David Creighton provides an update on the regulations surrounding the shipping of used medical devices, and explains how a recent change in classification may allow shippers of these devices to avoid the most stringent requirements of the dangerous goods transportation regulations.
On 1 January 2013 the international regulatory bodies that oversee the air transport of infectious and biological substances worldwide published a new exception to the regulations expressly for shipments of used medical devices. The new exception permits used medical devices to be transported without the stringent requirements previously in place. With this recent publication, it is advisable to review the rationale for the development of these regulations, outline the current requirements and discuss future changes.
For the purposes of transportation safety, infectious substances are considered dangerous goods and therefore subject to the dangerous goods transportation regulations.
The transportation regulations define used medical devices as those medical devices that have been removed from their original packaging, potentially contaminated by contact with a patient (human or animal) and are being returned to the manufacturer or other facility for repair, evaluation, sterilisation, disinfection or cleaning. This does not include shipping for waste purposes, in which cases shipments must be classified and shipped as regulated medical waste.
As far as the dangerous goods transportation regulations are concerned, the medical devices themselves are not the problem, but rather the biological material that may cause potential contamination. If the medical device contains a lithium battery, it may still be subject to the dangerous goods transport regulations; however, transportation of lithium batteries is outside the scope of this article. The main concern with these devices is the potential for contamination by an infectious substance (a disease-causing agent). The transportation regulations outline specific packaging and communication requirements to help ensure that anyone who comes into contact with these packages during transportation is protected against exposure to any potentially infectious substances.
Primary sources for regulations
The transportation of dangerous goods is governed by a number of national and international regulatory bodies, with the World Health Organization in particular playing a key role in establishing the regulations for the transportation of biological and infectious substances. However, the primary source for the regulations is the United Nations (UN). The UN has established a Subcommittee of Experts on the Transport of Dangerous Goods (UNSCOE TDG) from around the world, and from many different fields. After deliberation and consultation, UNSCOE has published its Recommendations on the Transport of Dangerous Goods - Model Regulations. The UN Model Regulations serve as a basis for all other transportation regulations. The main source for shipments of dangerous goods by air falls to the International Civil Aviation Organization (ICAO), which is another branch of the UN. ICAO uses the UN Model Regulations as a base for its own regulations, but adds additional restrictions on account of the increased risks associated with air transport.
A comprehensive outline of the ICAO regulations is published in the organisation's Technical Instructions for the Safe Transport of Dangerous Goods by Air, or ICAO TI. Both the UN Model Regulations and the ICAO TI are updated every two years to allow for variations in the regulations according to new and emerging concerns, or to relax the requirements of existing regulations. The most recent update was on 1 January 2013.
The ICAO TI has different classification scenarios for shipments of biological and infectious substances. For those substances that are highly pathogenic (having the ability to cause life-threatening or fatal disease in an otherwise healthy individual) the classification is a Category A infectious substance. For all other infectious substances (those not causing life-threatening or fatal disease in healthy humans or animals) the classification is a Category B infectious substance. According to the classification scheme, when a medical device has been contaminated by contact with a human or animal, the appropriate classification would be a Category B infectious substance (although, if the medical device is contaminated by a patient who is known to have been or suspected of being infected with a Category A infectious substance, the used medical device must be shipped as a Category A infectious substance).
However, there are some substances that are not regulated by the transport regulations, such as a dried blood spot (blood applied to an absorbent material) or faecal occult blood-screening tests. There are other substances or materials that are exceptions to the regulations and, as a result, will have less stringent regulatory requirements. The latest update to the UN and ICAO regulations included a new exception to the regulations for shipments of used medical devices that previously would have been classified as Category B infectious substances. This exception permits the shipper to transport by air the used medical device as either a Category B infectious substance, or as a "used medical device". If the shipper (often the manufacturer) decides to ship the used medical device without the Category B classification, the package does not need to meet all the stringent requirements of a Category B-compliant package.
The recently published used medical-device exception for international shipments is based on a similar pre-existing exception in the transport regulations used by the US Department of Transportation (DOT). The US Code of Federal Regulations (CFR) title 49 (49 CFR) section 173.134 (b) (12) (ii) outlines the requirements for shipping used healthcare products or used medical devices as an exception to the regulations, and also includes some basic packaging requirements. There have been no increased incidents of individuals being exposed to contamination since the introduction of this used medical device exception in the US, and consequently the UN has introduced a similar exception that may be adopted by other regulatory bodies. ICAO has recognised this new exception and added an air transport-qualified equivalent in its recent update to the Technical Instructions, which also became effective on 1 January 2013. The exception requirements in the international regulations are similar to those outlined in the 49 CFR, but not identical. There are some differences between the US and international regulations, one of which is the number of leak-proof layers required: international regulations mandate a single leak-proof layer, whereas the US regulations require two leak-proof layers. Fortunately, the US DOT recognises the ICAO TI as an acceptable substitute for air shipments within the US.
According to the ICAO TI, in order for a used medical device to be excepted from the transport regulations, it must meet a few packaging criteria. The device must be stored in a package that is designed to remain intact regardless of the handling and weather conditions it may undergo during transportation. This package must be of sufficient quality that it is not negatively affected by the temperatures, pressures, vibrations, weather, loading and unloading normally experienced during transport. In order to ensure the durability of the package design, it must be subjected to a drop test of 1.2m. The package design passes the test if the package retains the used medical device and the infectious substances do not leak.
In order to ensure that any liquid samples of infectious substances within the used medical device do
not leak, the device must be packed in leakproof packaging. If the outer packaging is not leakproof, the used medical device may be packed in a leakproof liner, where the liner is stored between the device containing the liquid and the outer packaging. When the package is complete and ready for transport, the outside must be marked with the words, 'used medical device', or 'used medical equipment'.
It should be noted that the packaging requirements in the new exception for used medical devices shipped by air are less stringent than those previously required for Category B infectious substance air shipments. For Category B infectious substance packages, there must be two leakproof layers in addition to the outer packaging. For liquid shipments in a compliant Category B package, one of those leakproof layers must be able to withstand an internal pressure of at least 95kPa. Additional requirements for Category B shipments include package tests under simulated rain and freezing conditions, as well as specific documentation and markings on the package.
With this in mind, the requirements outlined in the new exception for used medical devices should represent the absolute minimum standard for shipping used medical devices by air. If the shipper is uncomfortable with the minimum standards, it is always acceptable (and often advisable for liability concerns) to exceed the minimum requirements by using Category B infectious substance packaging. For example, there may be contamination concerns when a manufacturer requires the used medical device to be returned to their facility, where it will be unpacked by their own staff. Ultimately, the decision will depend on the individual organisation's policies, procedures and liability concerns.
Larger medical devices
Even though the new exception to the regulations provides shippers of used medical devices with a less stringent manner of shipping them, there are still a few questions and concerns for shipments involving larger medical devices. Many of these larger medical devices are significantly heavier and often more expensive than the smaller ones, and it is possible that the drop test procedure could damage the device, or even render it unusable. A loss of this type may be acceptable for smaller or less expensive medical devices, but for larger and more expensive ones, the testing procedure could prove extremely costly.
Consequently, regulators are in the process of revising the newly updated regulations to allow for packages designed for larger used medical devices to be excepted from the testing procedure. This change in the regulations will be published and come into force on 1 January 2015. Until then, the criteria used to determine what will be considered a larger used medical device remains unclear.
A work in progress
There are also a few other issues with the new used medical device shipping regulations that are currently being discussed by the regulatory bodies. It is very likely that not all of these issues will be resolved before the January 2015 publication; therefore, it is advisable for anyone who is potentially affected by the transport of used medical devices regulations to continue to monitor the changes in the next few editions of the regulations.
As with most changes to the transportation regulations, it is difficult to predict all of the factors that might be affected. Consequently, it may take several revisions before a regulation best serves all interested parties. The 2013 publication of a shipping exception for used medical devices is the beginning of what may be a lengthy process.
However, the exception has laid the groundwork, and a large portion of used medical devices shippers will benefit from it.