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Safety first: protective packaging

Outbreaks like West Africa’s recent Ebola crisis often require used medical devices to be transported within countries and across international borders, so it is vital that packaging preserves the integrity of materials and prevents contamination. David Creighton, regulatory and training manager at Saf-T-Pak, explains how to conform to safety regulations and minimise risk.

Bioharzardous materials are regulated by national and international agencies in order to protect the public. For maximum security, the rules are written with worst-case scenarios in mind, though in most accidents/incidents, the criteria turn out not to have been fulfilled. The outbreak of the Ebola virus in West Africa (and its subsequent spread to other locations around the world) made an extreme event reality for those involved with packaging and transporting bioharzardous specimens, increasing awareness of any possible logistical deficiencies as a consequence.

Worst-case scenarios are when individuals contract diseases as a result of being exposed to the contents of regulated packages.

‘Exposure’ is deemed to have occurred when bioharzardous material is present on the outside of a box, causing the possibility of direct contact with anyone who has handled it while performing normal transport duties, such as lifting or carrying. There could be a number of reasons for this contact.

A package might be punctured, for example, causing the contents of the inner receptacle to leak, or a container could be crushed, causing whatever is inside to soak through. While a bioharzardous leak does not guarantee contraction of a disease, the context of exposure will include additional factors, such as the mode of transmission and what constitutes an infectious dose.

For an exposure to occur, every factor must be optimal to cause a disease in the individual handling the package. In worst-case exposures, diseases may cause disability, or be life-threatening, or even fatal to an otherwise healthy person.

For example, a package containing a medical device that was used on a recently deceased Ebola patient could be torn open by a forklift at a sorting facility. The machine operator might investigate the damage, handle the contaminated medical device and subsequently contract Ebola.

While the likelihood of this exact sequence of events occurring is slim, every possible precaution must be taken to ensure minimal exposure in such circumstances.

Risk assessment

Under transport regulations, substances are considered biohazardous if they are known, or suspected, to contain any microorganism able to cause disease in humans or animals (pathogens). Such materials are deemed infectious and classified into different categories.

Those in category A are in a form that can cause permanent disability, or life-threatening illness, in healthy individuals, while those category B do not tend to have these capabilities.

"Exposure is deemed to have occurred when bioharzardous material is present on the outside of a box, causing the possibility of direct contact with anyone who has handled it while performing normal transport duties, such as lifting or carrying." 

Transporting biohazardous (and potentially biohazardous) material is subject to strict national and international regulation. Shipping substances that contain, or might contain, biohazardous materials must be correctly classified, packaged appropriately in order to minimise the potential for exposure, and carry detailed risk information for transport handlers in the form of special marks, labels and documentation.

The regulatory requirements are reduced appropriately for lower-risk materials, and those posing minimal threat may even be conditionally exempt. Such an exception might apply to used medical devices that have been extracted from patients and are being returned to manufacturers, or shipped for sterilisation, repair or analysis.

Since the item is contaminated with potentially biohazardous material, it must be classified according to biohazardous or infectious substances criteria. Any medical device that has been removed from (or used on) a patient infected, or suspected of being infected, with a category A substance must be shipped as a category A infectious substance. High-risk category A substances can include haemorrhagic fever viruses and related pathogens such as (but are not limited to): the Ebola, hantavirus, Marburg, monkeypox and Variola viruses, and smallpox.

If the material contaminating the used device is not suspected, or known, to be a category A pathogen, it can be classified as a category B infectious substance. A device with a category B contamination can be shipped under a conditional exception, or as a category B infectious substance. When the source of contamination from the patient is unknown, or not suspected of being infected with a critical pathogen, the device may travel under a conditional exception. Although provisions for used medical devices stipulate certain packaging, package testing and marking requirements, these are less stringent that those for biohazardous substances, especially when shipping by air.

Category A infectious substances are subject to extremely strict guidelines and regulations. First, and most importantly, shippers must be trained in every requirement for transporting such materials. Category A packaging requirements include the stipulation that every design must be able to be survive a 9m drop without breaking, or any leakage from the primary receptacle (the layer closest to the infectious substance).

The specifications for packages containing infectious substances were developed by the UN to ensure that category A packages are transported carefully and efficiently. Specific hazard communications – including marks, labels and documentation – are required and shippers must be properly trained in these. The correct documentation is of paramount importance, as any error will result in packages being rejected.

Fear of rejection

When transporting infectious substances, operators and carriers must ensure that every shipped item complies with regulations, even before it enters the sorting process, as it will then come into contact with other packages. Carriers use a detailed checklist to inspect each category A package and its accompanying documentation, and if errors are found, the entire shipment is rejected. Operators have the right to mandate additional operator-specific variations to the regulations, provided they are not less restrictive than the established regulations.

To avoid the possibility of shipment rejection, a shipper must ensure that every applicable regulation has been followed exactly, including any possible variations. For example, all category A infectious substance shipments sent via Federal Express from the US must be accompanied by documentation that is created by an approved, computer-generated error-checking program. If this rule is not followed, the shipment will automatically be rejected.

Many category A infectious substances have the potential for misuse in bioterrorism, so strict security measures are required. Consequently, operators transporting high-risk pathogens must have the necessary security clearance. Several of these are also classified as ‘select agents’ by the Centers for Disease Control (CDC), and as such, are highly regulated. In many cases, a permit is required to transport these high-risk specimens. Exceptions exist in the regulations that permit shipments of select agents to entities that normally don’t accept them, but these only apply to specimens that are being shipped for diagnostic, verification or proficiency testing, and never to used medical devices. While the CDC can still grant permission for these types of shipments without a permit, the shipper must obtain verification before passing the cargo to an operator. International shipments require import and/or export permits and it is important to contact the relevant governmental departments beforehand in order to verify and then correctly complete whatever paperwork is necessary to secure the requisite permits.

Although shipping companies are unlikely to carry anything infected with Ebola (or another high-risk pathogens), it is vital that anyone who might conceivably be involved in processing biohazardous substances is trained in their proper packaging, marking and documentation.