Eighth Edition - R.3 - Human Fertilisation & Embryology Authority

Mandatory requirements (cont)
(b) embryos that have been created using cryopreserved eggs with embryos created using
fresh eggs, or
(c) cryopreserved embryos that have been created using cryopreserved eggs
with cryopreserved embryos that have been created using fresh eggs.
T85
A documented risk assessment must be undertaken to determine the fate of all stored gametes and
embryos following the introduction of any new donor/patient selection or testing criterion or any
significantly modified processing step that enhances safety or quality.
Directions
0007 – Consent
For a copy of the relevant Directions visit www.hfea.gov.uk
Regulations
The Human Fertilisation and Embryology (Statutory Storage Period for Embryos and Gametes) Regulations 2009
Copies of this legislation can be found at www.opsi.gov.uk
v
HFEA guidance
Facilities and documented procedures
17.1 The centre should establish documented procedures to ensure that all storage and handling of gametes
and embryos comply with licence conditions, regulations, and relevant patient and donor consent.
17.2 The centre should ensure that the storage facilities for gametes and embryos:
(a)
are dedicated for the purpose, and adequate for the volume and types of activities
(b)
(c)
are designed to avoid proximity to ionising radiation (radioactive material), any known
potential source of infection, or chemical or atmospheric contamination, and
have a storage-location system that minimises the amount of handling required to retrieve
gametes and embryos.
17.3 The centre should also have emergency procedures to deal with damage to storage vessels,
failure of storage conditions or both.
17.4 The centre’s documented procedures should also ensure that:
(a) gametes and embryos are stored under controlled conditions that are validated
and monitored
(b)
gametes and embryos are packaged for storage in a way that:
(i)
(ii)
prevents any adverse effects on the material
minimises the risk of contamination
(c)
(d)
(e)
records are kept indicating every occasion when gametes and embryos are handled during
storage and release, and by whom
records are kept indicating that gametes and embryos meet requirements for safety and
quality before release, and
risk assessments (approved by the person responsible) are done to determine the fate
of all stored material whenever any of the following is introduced:
Human Fertilisation and Embryology Authority
Guidance note | 17. Storage of gametes and embryos
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