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

v
HFEA guidance (cont)
17.4 (cont)
(i)
(ii)
a new donor selection criterion
a new criterion for testing donors, patients’ partners or patients
(iii) a new processing step to enhance safety, quality or both
(iv) a new procedure for appropriate disposal of gametes and embryos.
Safety of equipment used to store cryopreserved gametes and embryos
17.5 Centres should store gametes and embryos in a designated area. Access to this area should be limited
to staff authorised under the terms of the centre’s licence. Cryopreservation dewars should be fitted with
local alarms and be linked to an auto-dial or similar facility, (eg, a link to a fire alarm board) to alert staff
to non-conformities outside normal working hours.
17.6 The centre should have adequate staff and funding for an ‘on-call’ system for responding to alarms out
of hours, and adequate spare storage capacity to enable transfer of samples if a dewar fails.
17.7 A centre storing gametes and/or embryos for patients whose future fertility may be impaired by a medical
condition or procedure should divide individual patients’ samples into separate storage vessels, in case
of dewar failure.
See also guidance note:
26 – Equipment and materials
Screening and storage of samples to prevent cross-contamination
17.8 The centre should ensure that no gametes or embryos are placed in storage unless the people
who provided the gametes have been screened in accordance with current recommended
professional guidelines.
17.9 Centres should:
(a) assess the risks of cross-contamination during the quarantine period
(b) put procedures in place to minimise these risks, and
(c) document the rationale for the chosen quarantine procedures.
See also guidance note:
15 – Procuring, processing and transporting gametes and embryos
19 – Traceability
20 – Donor assisted conception
Storing ovarian and testicular tissue
Interpretation of mandatory requirements
Ovarian and testicular tissue, as cells of the germ line, fall within the definition of gamete in the
Human Fertilisation and Embryology Act 1990 (as amended) and so are subject to the same storage
requirements as sperm and eggs.
17A
Human Fertilisation and Embryology Authority
Guidance note | 17. Storage of gametes and embryos
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