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07 June 2004

Dear Colleague

Guidelines on the Safety of Equipment used to store cryopreserved gametes and embryos in Assisted Reproduction Laboratories

You will be aware through the Alert system that there have been several incidents reported to the HFEA that have involved the loss of cryopreserved gametes and embryos due to inadequate levels of liquid nitrogen in the storage vessels (dewars). These have been caused by acute and / or gradual equipment failure, human error and / or inadequate protocols and controls for filling the level of liquid nitrogen in the dewars. The HFEA has therefore reviewed the safety of equipment used to store gametes and embryos in assisted conception laboratories. As part of this process we carried out an initial Regulatory Impact Assessment (RIA) and then consulted all licensed centres.

We have now analysed the responses to the consultation and have decided to issue guidelines on the safety of equipment used to store cryopreserved gametes and embryos. These guidelines are intended to protect the safety of cryopreserved gametes and embryos stored in assisted reproductive laboratories. The results of the consultation together with the completed Regulatory Impact Assessment are available on the HFEA website. 

Under the new guidelines the HFEA will expect all centres storing patients' gametes and embryos (including donor gametes stored for ´sibling use') to have effective alarms and monitoring systems in place to ensure the safety of cryopreserved gametes and embryos. These systems need to perform the following functions:

• Local alarms i.e. on individual dewars for either temperature or liquid nitrogen level;
• Auto-dial (or similar e.g. link to fire alarm board) facility to contact staff outside normal working hours;
• Adequate staffing  and funding to allow the implementation of formal emergency procedures including ´on-call';
• Adequate spare storage space and / or  vessels to enable transfer of samples in the event of a vessel failure.

Centres are expected to have the appropriate alarms and monitoring system in place by the end of June 2005.

In relation to the installation of oxygen alarms and ventilation systems the HFEA will be liaising with the Health and Safety Executive before issuing any guidelines.

Furthermore, centres storing gametes and / or embryos for patients whose fertility may be impaired by medical treatment are now expected to divide individual patients' samples into separate storage vessels. All centres are expected to implement this policy immediately for all new patients storing gametes and / or embryos prior to having medical treatment that may affect their future fertility. All centres are expected to split gametes and / or embryos stored for existing patients whose fertility may have been impaired by medical treatment, during the centre's next annual audit of stored material. Therefore, all samples should be divided into separate storage dewars by the end of June 2005.

Compliance with these guidelines will be assessed through the HFEA's inspection and licensing process. If you have any queries with regard to this new policy please contact Charles Lister, Head of Policy on 020 7291 8230, or by e-mail at charles.lister@hfea.gov.uk.

Yours faithfully,

Suzi Leather
Chair

Page last updated: 17 August 2012

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