HTA voices concerns over unlawful cord blood collection

The HTA is writing to over 150 organisations to warn of concerns that unlawful umbilical cord blood collection may compromise safety and quality standards.

Issue date: 9 March 2010

This follows a number of incidents where parents collected cord blood unlawfully, and other cases where medical staff felt pressured to collect cord blood unlawfully without specialist training.

Since 5 July 2008, cord blood can only be collected under an HTA licence by suitably trained staff. This regulation is essential to ensure that cord blood is collected safely, that the sample is not contaminated and is safe to use. The HTA is writing to maternity units, licensed establishments and professional bodies to voice concerns about unregulated and unlawful cord blood collection; over 150 organisations in total.

The HTA is urging parents considering cord blood banking to discuss the practicalities of collection at an early stage of pregnancy. Where the hospital does not hold a licence it may be possible to get a trained specialist to carry out the collection. However, this usually needs to be organised well in advance of the birth.

Cord blood regulation by the HTA ensures that:

• staff have training to help ensure collection is performed safely; the sample is not contaminated and is safe to use
• procedures are in place that help prevent medical attention being diverted from mother or child during the third stage of labour
• systems are provided to make sure the cord blood cells are traceable from collection to their use in treatments

Dr Shaun Griffin, Director of Communications at the HTA said:

“Collection of cord blood is the same as any other medical procedure: it needs to be carried out safely by trained staff, because collection is not without risk to the mother and baby.

“We don’t want parents to leave it too late to organise collection because, if things go wrong, it can cause distress and the sample could be wasted. We know of incidents where parents have brought cord blood kits into the delivery room and put pressure on untrained medical professionals to collect cord blood.

“We are also aware of incidents where parents have collected the cord blood themselves, or the collection has taken place outside. In at least one case, cord blood was collected in the hospital car park. This risks the quality of the sample as collecting under these circumstances is likely to lead to contamination.

“18 months after we began regulating cord blood collection we are providing more advice and guidance to ensure that professionals and the public are fully aware of the legal requirements. We are writing to professional bodies, maternity units and cord blood banks, and providing more information for public and professionals on our website.”

Royal College of Midwives’ (RCM) General Secretary Louise Silverton said:

“The RCM supports this work as it helps ensure that midwives are able to focus their full attention on caring for the mother and baby. The time during the birth when cord blood is collected is one of the riskiest times, in terms of safety. Therefore, it is essential that midwives are able to concentrate on the birth and are not put under pressure to carry out unregulated and unlawful cord blood collections.

“If parents are thinking about cord blood banking, they need to discuss this with their midwife, or other health professional, to find out if collection is viable. Organising collection by a specialist trained professional can take time, so parents should not wait until close to their due date to begin organising a collection.”

END

For further information, please contact Claire Bithell, Senior Media Advisor at the HTA on 0207 211 3439 or claire.bithell@hta.gov.uk

For more information about the RCM, please contact the RCM Press Office on 020 7312 3456 or pressofficer@rcm.org.uk

Notes to editors

• The HTA provides information for parents considering cord blood collection:  Cord blood collections are increasing in the UK; in 2009 there were 15,514 cord blood collections compared to 14,335 in 2008.
• This regulation forms part of the European Union Tissue and Cells Directives (EUTCD). 
• The EUTCD came into force from 7 April 2006 throughout the EU and was transposed into UK law via the Human Tissue (Quality and Safety for Human Application) Regulations on 5 July 2007. The HTA is one of two Competent Authorities in the UK for the EUTCD. 
• Procurement organisations (that collect cord blood) required a licence under the Human Tissue (Quality and Safety for Human Application) Regulations from 5 July 2008.
• The Human Tissue Authority (HTA) is an independent watchdog that supports public confidence by making sure human tissue is used safely and ethically, and with proper consent. We license and inspect organisations that store and use human tissue for purposes including teaching about the human body, carrying out post-mortem examinations, using human tissue to treat patients, carrying out research on human tissue and displaying human bodies or tissue in public. We also give approval for donations of organs and bone marrow from living people.
• The HTA provides advice and guidance about two laws: the Human Tissue Act 2004 and the Human Tissue (Quality and Safety for Human Application) Regulations 2007. These laws ensure human tissue is used safely and ethically, with proper consent.
• More information about the HTA can be found on our website
• The Royal College of Midwives is the voice of midwifery. It is the UK’s only trade union and professional organisation led by midwives for midwives. The vast majority of the midwifery profession are members. The RCM promotes midwifery, quality maternity services and professional standards. They support and represent their members individually and collectively in all four UK countries.  The College influences on behalf of its members and for the interests of the women and families for which they care.  For more information visit the RCM website 
• Organisations that provide information about cord blood banking for parents include: 
• NHS Cord Blood Bank
• RCM
• Royal College of Obstetricians and Gynaecologists
• Genetic Interest Group