The collection of blood and blood components requires the use of many parts such as blood bags, tubing, filters, valves, devices and attachments. Blood bags are thus closed systems composed of one or more sterile containers made from plastic materials.

Blood bag sets have been demonstrated to be safe and efficient.

The use of blood bag sets for the collection of donor blood is being regulated strictly, by the Medical Devices Regulation and the Blood Directive. In addition to these two legal frameworks, in some countries, blood bag sets become medicinal products as soon as they are blood-filled and further processed, and consequently become subject to the corresponding pharmaceutical regulations. Blood bag sets are therefore regulated two to three times which make them particularly safe.

As an integral part of modern medicine, blood transfusions are used in a wide range of treatments that are often lifesaving. The World Health Organization (WHO)[1] reports that blood transfusion saves lives and improves health, but many patients requiring transfusion do not have timely access to safe blood. Providing safe and adequate blood should be an integral part of every country’s national health care policy and infrastructure.

In high-income countries, transfusion is most commonly used in cardiovascular and transplant surgery, in massive trauma and therapy for solid and haematological malignancies. In low- and middle-income countries, transfusions are used more often to manage pregnancy-related complications and severe childhood anaemia.

Ensuring appropriate blood supply is therefore critical. The members of BTA are committed to supporting the correct use and safe supply of blood for transfusion.

[1]  WHO, Blood safety and availability Fact sheet, 14 June 2019. Available at: www.who.int/en/news-room/fact-sheets/detail/blood-safety-and-availability

Blood bag sets contain a substance known as Di-2-ethylhexylphthalate, or DEHP.

What is DEHP? It is a plasticizer used in the manufacturing of blood bag sets which extends the shelf life of the stored red blood cells up to 49 days by interacting with the membrane of the said cells and making it more resistant.

Through the interaction between DEHP and the membrane of red blood cells, the process of haemolysis – which is the rupturing of red blood cells and the release of haemoglobin – is slowed down, thereby extending the storage period. Consequently, it is estimated that the use of DEHP results in a reduced amount of discarded blood, contributing to ensuring appropriate blood supply on the European markets.

In the European Union, the use of chemicals is regulated by the Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

When it comes to the Authorisation of chemicals, REACH includes an Annex XIV which lists the substances that are subject to prior authorisation for specific uses. Once included in that Annex, a substance cannot be placed on the market or be used after a given date (the so-called ‘sunset date’) unless the companies concerned, who cannot replace that substance, are granted authorisation for the specific use(s).

Although DEHP is included in the Authorisation List, an exemption is made for medical devices.

On July 2019, the European Chemicals Agency (ECHA) published a recommendation to amend the REACH Authorisation list (Annex XIV). Specifically, ECHA recommends removing the exemption from Authorisation for the use of DEHP in medical devices, including blood bag sets.

Although potential alternatives to DEHP have been investigated, these substances do not perform as well as DEHP beyond blood storage considerations. A sunsetting of DEHP would therefore have a direct impact on the performance of blood bag sets and the supply of blood for transfusion to the patients in need.

To ensure the correct implementation of the Medical Devices legal framework, the European Commission publishes guidance documents. Currently, the Guidance Document on the Classification of Medical Devices (MEDDEV 2) classifies blood bag sets containing or coated with anticoagulant under Class IIb. This document also states that “other rules may apply” for blood bags that have functions other than storage and include systems for preservation other than anticoagulants.

What does this mean?

Medical devices are assigned to different classes depending on the level of perceived risk associated with their use: from class I (low risk) to class III (high risk). Under the Medical Devices Directive (MDD), blood bag sets are classified as class IIb medical devices.

The Medical Devices Regulation (MDR) amending the MDD entered into force in 2017 and will apply from May 2021. Like the MDD, the MDR lays out classification rules for medical devices including blood bag sets. As part of the implementation of the MDR, a guidance document on the classification rules will be published by the European Commission. In this context, blood bag sets containing anticoagulants and storage solution may be considered as class III products due to the combined interpretation of classification rules. Severe concerns have been raised by blood bag manufacturers regarding the impact that a potential up-classification would have on the availability of blood bag sets in the European Union.