The Medicines and Healthcare products Regulatory Agency (MHRA) is asking women not to use the ‘Baby Beets Fetal Doppler’ after concerns that it might not reach the required standards of safety and quality, or that it works, as required by the Medical Devices Regulations. The MHRA was alerted to the product being sold on the Internet by a legitimate manufacturer of foetal monitors. As there is no evidence that the safety and performance of this product has been assessed in accordance with the Medical Devices Regulations, the product could pose a potential risk to the mother and/or baby in respect of any energy emitted.

Clive Bray, Director of Device Technology and Safety at the MHRA said, “The MHRA is currently assessing certain safety aspects of the product. It must be stressed that initial indications are that the health risk to a pregnant woman and/or their baby is small. However, as a precautionary measure, I strongly urge anyone using this product to immediately discontinue use.”

The MHRA has seized 113 of these products and advises people selling this product to stop and remove it from their stock. 

In general, a medical device cannot be marketed in the UK without carrying a CE Mark of Conformity. A CE mark is applied by the manufacturer to denote that the device meets the relevant regulatory requirements and performs as intended. For all but the very lowest risk devices, such as unmedicated bandages, an EC Certificate of Conformity must be obtained from an independent certification organisation, called a Notified Body, before the CE marking can be affixed. The MHRA is responsible for designating UK Notified Bodies and regularly audits them to ensure that they continue to perform to the required standards. Foetal dopplers are a Class IIa device and would need an EC Certificate from a Notified Body. The ‘Baby Beets Fetal Doppler’ incorrectly claims to be CE marked and that its EC representative is Lloyds Pharmacy.

4. If people wish to send this product to the MHRA, they should send it to:
Medical Devices Compliance Unit
Medicines and Healthcare products Regulatory Agency
8/2 Market Towers
1 Nine Elms Lane
London
SW8 5NQ

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It is slightly more than two and a half years since UK law regarding donor anonymity was changed, and which now allows individuals aged 18 or over who were conceived following donor conception undertaken since April 2005 to learn the identity of their donor.

This change in legislation was not universally endorsed; it was opposed by associations with strong medical orientations, the British Fertility Society, the British Medical Association and the Royal College of Obstetricians and Gynaecologists. The position of the BMA was especially interesting since the recommendation of its Ethics Committee, supporting the removal of anonymity, was rejected by the Association’s membership (British Medical Association, 2004).

Concerns about the removal of donor anonymity centre on two major areas:

   1.      the potential impact on donor supply;
   2.      the willingness of parents to inform their donor-conceived children about their conception.

The government made clear that, since parliament had quite recently debated and voted on donor anonymity, it did not propose that the Human Fertilisation and Embryology Bill, currently before the House of Lords, should be used as an opportunity to re-examine the issue. Indeed, the Bill proposes to extend the rights of donor–conceived people to learn the identity of “donor half siblings” (where necessary consent is provided). When the Human Tissue and Embryos (Draft) Bill (Department of Health, 2007), precursor to the Human Fertilisation and Embryology Bill (2007), was reviewed by a joint committee of the House of Lords and House of Commons earlier this year, the committee proposed an even more radical measure (not included in the present Bill) that the birth certificates of donor-conceived people should be annotated in a way that would indicate the nature of their conception (House of Lords and House of Commons, 2007).

It seems, however, that the BMA, at least, wishes parliament to debate the issue of donor anonymity once more, in the hope that legislators will reverse their previous decision. In a briefing on the Bill, the Association states:

"Anonymity of donors
The BMA opposed the removal of donor anonymity which Parliament approved in the 2004 Human Fertilisation and Embryology Authority (Disclosure of Donor Information) Regulations. Since April 2005, anyone registering to be a donor has done so knowing that any child born as a result of the donation can seek identifying information about them once the child reaches the age of 18. The BMA is disappointed that the Government has not taken the opportunity of this bill to review the policy.

The BMA believes that the removal of donor anonymity has had a detrimental impact upon the availability of treatment with donor gametes. Despite reports from the HFEA that the number of men registering as sperm donors has increased, the number of women registering as egg donors continues to fall. The number of people registering as donors may not give an accurate picture of the number of donor conception treatments taking place and the length of time that prospective patients have to wait for treatment.

The BMA would like to see increased openness between parents and their donor-conceived children. We are concerned that the removal of donor anonymity may have made such openness less likely. Parents who are unwilling for their child to make contact with the donor when they reach 18 may be less likely to tell their child they were donor conceived” (British Medical Association, 2007).

While it is reassuring that the BMA has not subscribed to the “donor crisis” moral panic, it should be noted that a shortage of donors is reported in many countries, including those that protect donor anonymity. The only exceptions appear to be in countries where donors are paid and where, unlike the UK, commodification of women’s reproductive capacity is considered acceptable. In any event, the argument concerning donor recruitment begs completely the question as to whether the ethical issues (as identified originally by the BMA Ethics Committee) should so easily be trumped by utilitarian considerations.

The most surprising (and disappointing) element of the BMA position given that it represents a profession strongly committed to evidence-based practice, is the claim that the removal of donor anonymity might make it less likely that parents would tell their donor-conceived children about their conception. There is absolutely no evidence to support this position.

It has to be said that, in a context historically lacking in transparency - the result of accepted medical practice that considered it best for all concerned for donor conception to be undertaken “discretely” (a practice itself totally devoid of an evidence base) - evidence is in chronic short supply. However, what evidence that does exist runs counter to the BMA position.

In 1984 Sweden became the first country in the world to remove donor anonymity. Prior to the change in Swedish legislation, in a study reported by Milsom and Bergman (1982) only 1 of 92 couples interviewed intended to tell their child that they had been conceived using donor conception.

In 2000, Gottlieb et al. reported that 11% of parents of donor-conceived children studied had told their children about the nature of their conception (6% of parents of children born between 1983 and 1986 [i.e. before the change in legislation] and 18% of parents of children born after 1987). A further 40% of parents interviewed stated their intention to tell their child “later”. This same group of parents was interviewed again some years later (Lalos et al., 2007). By the second interview, 61% had already told their child about his or her conception, and a further 22%, who had not yet told their child(ren), were still intending to do so.

Indirect support for the Swedish findings is available in a forthcoming study drawing on the experiences of counsellors in UK licensed clinics (Crawshaw, in press). Half of the counsellors who were in post both before and after the removal of anonymity indicated that there had been an increase in the numbers of prospective parents stating their intention to tell their children about their origins. Taken together with those counsellors who said that, prior to the change in legislation, most prospective parents had stated their intention to tell their child, around 70% of parents indicated to counsellors their support for openness.

I make no claim that these studies prove that the change in legislation to remove donor anonymity has brought about changes in parental disclosure practice. However, they clearly do not support the claim that its removal will increase the likelihood that parents will not disclose, and are the only published evidence available that establishes any correlation between the legislative removal of donor anonymity and parental disclosure practices.

Already there are four distinct groups of donor-conceived people in the UK, distinguished by different opportunities to access information about their genetic history:

   1.  those who were conceived as a result of a procedure undertaken prior to August 1991, for the majority whom no records exist at all, but who may be able to ascertain information about/existence of genetic relatives via the voluntary contact register maintained by UKDonorLink;

   2.  those who were conceived as a result of a procedure undertaken between August 1991 and June 2004, who will have access to generally limited non-identifying donor information held by the Human Fertilisation and Embryology Authority;

   3.  those who were conceived as a result of a procedure undertaken between July 2004 and March 2005, who will have access to an increased range of non-identifying donor information held by the HFEA;

   4. those who were conceived as a result of a procedure undertaken after April 2005, who will have access to both non-identifying and identifying donor information.


It would be folly to change again the UK’s approach to donor anonymity. Not only would such a decision undermine the human rights of donor-conceived people, it would create considerable confusion among service providers and service users and further inequity between donor-conceived people.

References

British Medical Association (2004) Memorandum from the British Medical Association, Appendix 12. Ev 228. In House of Commons Science and Technology Committee (2005) ‘Human Reproductive Technologies and the Law’ Fifth Report of Session 2004-05. Vol II: Oral and Written Evidence http://www.publications.parliament.uk/pa/cm200405/cmselect/cmsctech/7/7ii.pdf

British Medical Association (2007) Human Fertilisation and Embryology Bill

House of Lords, November 2007 http://www.bma.org.uk/ap.nsf/Content/HFEBill?OpenDocument&Highlight=2,Human,Fertilisation,Embryology,Bill

Crawshaw, M. (in press) Prospective parents’ intentions regarding disclosure following the removal of donor anonymity. Human Fertility

Department of Health (2007) Human Tissue and Embryos (Draft) Bill. Cm 7087. http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsLegislation/DH_074718

Gottlieb, C., Lalos, O. and Lindblad, F. (2000) Disclosure of donor insemination to the child: the impact of Swedish legislation on couples’ attitudes. Human Reproduction. 15: 2052-2056.

House of Lords and House of Commons (2007) Joint Committee on the Human Tissue and Embryos (Draft) Bill. Volume I: Report http://www.publications.parliament.uk/pa/jt200607/jtselect/jtembryos/169/169.pdf

Human and Fertilisation and Embryology Bill [HL] (2007) http://www.publications.parliament.uk/pa/ld200708/ldbills/006/2008006.pdf

Lalos, A., Gottlieb, C. and Lalos, O. (2007) Legislated right for donor-insemination children to know their genetic origin: a study of parental thinking. Human Reproduction 22(6): 1759–1768.

Milsom, I. and Bergman, P. (1982) A study of parental attitudes after donor insemination. Acta Obstetrica et Gynecologica Scandinavia. 61:125–128.

Eric Blyth CQSW BA MA PhD
Professor of Social Work
University of Huddersfield
Queensgate
Huddersfield HD1 3DH
England
Tel: +44 (0) 1484 472457
Fax: +44 (0) 1484 472794
http://www.hud.ac.uk/hhs/research/acs/staff/eb.htm

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