Some key applicable points from the regulation surrounding the use of medical bags and boxes
The regulations surrounding the use and application of bags and boxes for transporting medical items can appear complex. This complexity can lead to concern as to whether health trusts are unknowingly falling foul of regulatory requirements. This short-form article summarises the Versapak interpretation of the main regulations:
ADR (which stands for Accord européen relatif au transport international des marchandises Dangereuses par Route) is a European Agreement covering the Carriage of Dangerous Goods by Road and is borne from a UN treaty governing transport of hazardous materials. Each country may have a national document which also enforces the ADR. In the UK this is the CDG (Carriage of Dangerous Goods) regulation.
Within these regulations are included some key requirements: Firstly, the ADR examines different types of biological and infectious substances and identifies two categories of substance; category B (contains an infectious substance that is not generally capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs) and category A (containing pathogens that would present a hazard).
Secondly, if a diagnostic substance has been classified as belonging to UN3373, then it must be packed for transport according to a set of guidelines known as P650, or Packing Instruction 650. This is a list of requirements covering the quality and construction of the packaging used for transport.
Versapak bags are compliant with ADR regulations and can be used to transport UN3373 Category B substances but not for category A infectious substances. The user must decide whether the item to be carried is a category B infectious substance and then decide if items should be packed in accordance with P650. What this specifically means is that in each case the user must decide if it necessary to label the bag with a UN3373 identifier.
The Versapak tamper evident seal system is recommended for additional assurance, though this is not mandatory. It can be considered as good practice as are the use of liners which are required if there is a potential for leakage.
Versapak bags, for the purposes of medical transport can also be classified as boxes (if boxes are required) as the VCA Dangerous Goods Office: define a ‘rigid’ box along these lines:
- Stands up on its own with no closures in place
- Has 3 dimensions
- Has a basic ability to hold its shape
Versapak medical bags do this, so can be classed as boxes.
Some guidance on specific categories of items to be transported:
If the user deems these to be category B then a UN3373 label should be used on the bag.
Blood for transfusion
This is not part of ADR, so UN3373 labelling is not needed on the bag. JPAC guidelines suggest use of temperature monitors.