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Transport of medical samples – methods and legal regulations

Publication date: March 05, 2025

Methods of transporting medical samples

Transport of medical samples is an essential element of the laboratory diagnostics process, the primary goal of which is to ensure the integrity, stability and quality of biological material at every stage of its movement – from the moment of collection to analysis in the laboratory. Properly organized transport minimizes the risk of sample degradation, contamination, loss of their diagnostic value and potential biological threats to medical personnel and the environment. In addition, precise adherence to transport standards, including appropriate temperature conditions, delivery time and compliance with applicable regulations and procedures, is crucial for obtaining reliable laboratory test results. Below are the main methods of securing medical samples by suppliers during transport.

  • Dry ice, or carbon dioxide (CO₂) in the solid state at a temperature of about 78.5°C below zero, is widely used in the transport of medical samples that require very low temperatures. Thanks to its cooling properties and sublimation (changing directly from solid to gas without leaving liquid), it is an effective and safe means for biological materials that require very low temperature transport. It is used to transport vaccines, biological materials, tissues, mRNA samples
  • Gel inserts are used in the transport of medical samples when the samples require maintaining a stable temperature that is not as extremely low as when using dry ice (inserts are used for materials that should be stored in the temperature range of 2°C to 8°C ).

Samples are transported in Styrofoam boxes – boxes made of Styrofoam covered with an additional insulating layer in the form of foil. The construction of such boxes allows them to be combined into one large box if necessary. Styroboxes provide excellent insulation, low weight and protection against moisture, which is important in ensuring resistance to damage for transported materials.

Samples are subject to special packaging and protection procedures. They must be marked with a sticker with a marking containing sample information, date, conditions, batch number, hazardous materials marking. There must also be cushioning, antibacterial barriers, quality control and training procedures must be implemented, the sample must be placed in inner, intermediate and outer packaging.

Legal regulations and standards

The transport of medical samples is subject to strict national and international legal regulations aimed at ensuring the safety of both the transported materials and the persons involved in their transport.

  • International standards: UN, IATA, ADR, ISO
  • UN – standards developed by the United Nations regulating the transport of hazardous materials, including medical samples containing potentially infectious substances. They define the rules for packaging and securing samples
  • IATA – The International Air Transport Association (IATA) has developed Dangerous Goods Regulations (DGR) , which define the rules for the transport of medical samples by air. These include requirements for, among other things, packaging, security, and documentation.
  • ADR – standards used in the land transport of biological materials regulated by the European Agreement ADR (Accord Dangereux Routier) concerning the international carriage of dangerous goods by land. These rules are in line with UN guidelines and regulate the securing of materials, driver training and markings of vehicles used for transport.
  • ISO – their use is a legal requirement to provide medical material transport services, e.g. the ISO 14001:2015 standard, which is a standard requiring companies to introduce training on the transport of samples in dry ice, GDP is also used – good distribution practices that companies must implement in order for products to be transported.
  • National regulations: Sanitary and technological standards
  • Act of 14 March 1985 on the State Sanitary Inspection: Specifies the principles of supervision over hygiene conditions in the transport of materials that may pose a threat to public health. The Act specifies the powers of the State Sanitary Inspection in the form of entry to facilities and means of transport and issuing decisions on immobilization of means of transport in the event of a threat to public health, suspension of transport and ordering the withdrawal of a sample (Chapter 3 of the Act)
  • Regulation of the Minister of Health of 22 April 2005 on handling contaminated biological material: Contains guidelines for safe handling of biological material, including the principles of its packaging and transport. Based on the regulation, the employer is obliged to take into account information on the potential presence of a harmful biological factor in a patient or animal and in materials and samples taken from them. This means that during the transport of such samples, the risk associated with the presence of these factors must be taken into account and both the staff and the work environment must be properly protected.
  • EU legislation
  • Regulation (EC) No. 1272/2008 (CLP) – concerning the classification, labeling and packaging of dangerous substances. The content of the regulation contains detailed requirements for labeling elements, such as pictograms, signal words, hazard statements and precautionary statements (Article 17) and specifies general principles for the packaging of substances and mixtures, including requirements for the tightness of packaging and its resistance to damage (Article 35)
  • Directive 2000/54/EC of the European Parliament and of the Council (EU) of 18 September 2000 on the protection of workers from risks related to exposure to biological agents. According to Article 6 (2) (i) of the Directive, the employer is obliged to implement procedures for the safe handling and transport of biological agents within the workplace.

Summary

Transport of medical samples is a key element of laboratory diagnostics, requiring not only appropriate logistics support, but also strict compliance with legal regulations and safety standards. Depending on the type of biological material, different transport methods are used, ensuring stable transport conditions. Ensuring compliance with applicable standards not only protects the health of employees and patients, but also allows for obtaining reliable laboratory test results. Therefore, it is so important to apply appropriate procedures and ongoing monitoring of changes in regulations so that the transport of medical samples is carried out safely and in accordance with applicable law.

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