Select Committee on Health Written Evidence

Memorandum by the British In Vitro Diagnostics Association (BIVDA) (PS 20)



  The British In Vitro Diagnostics Association (BIVDA) is the national trade association for manufacturers and suppliers of in vitro diagnostics (IVD) industry in the UK.

IVDs are the tests used for:

    —  Early detection or diagnosis of disease,

    —  Screening for disease pre-disposition,

    —  Monitoring of treatment and disease management,

    —  Ensuring the safety of the blood supply by screening for infectious diseases.

  Information from the results of IVD tests makes up 70% of the information in a patient's record.

  Most IVD products are used in hospital laboratories but they are increasingly being used to test patients at the point of care in both primary and secondary care settings.

  IVDs are produced to enable patients to self-test as part of long term disease management.

  There are also IVDs designed for and sold direct to consumers for home testing.

  The membership of BIVDA currently represents over 95% of the industry with more than 100 member companies. Membership includes UK subsidiaries of multinationals, UK SMEs and a number of start-up companies. These companies produce the whole range of IVDs from fully automated systems for laboratory use to simple pregnancy kits sold over the counter.


  BIVDA's submission focuses on two areas of concern:

    1.  Potential for harm arising from unregulated use of in vitro diagnostics within the NHS.

    2.  Lack of control of products marketed Direct-To-Consumer.

  BIVDA welcomes the Committee's inquiry into the area of patient safety and hopes the Committee's report will provide an opportunity to address gaps in regulation which may be affecting the quality of healthcare in the UK and increasing risk to both patients and the general public.


  1.1  Since 2003 there have been regulations in force for commercial suppliers of in vitro diagnostic medical devices in the EU under the In Vitro Diagnostic Medical Device Directive (98/79/EC). This has been transposed into UK law under the Consumer Protection Act (Medical Device Regulations, SI 618 2002). All manufacturers need to show extensive validation of their processes from initial design through to market with evidence to prove their claims for each product in order to meet the essential requirements of the regulations. This is shown by the CE symbol on the packaging and labelling of the product. The onus on manufacturers continues throughout the product's life with requirements for continual post-marketing surveillance and vigilance. Tests that are deemed to be high or moderately high risk (which include self-tests) are subject to a higher level of regulation including independent testing.

  1.2  Prior to the commercialisation of the IVD industry in the 1960's, all laboratory tests were developed and produced using very labour-intensive methods at the bench within hospital laboratories. Since this time, the industry has been producing increasingly sophisticated tests that are often automated and offer robust and reproducible data. However, in the UK the NHS is not required to meet the same standards for any tests developed and utilised within the hospital laboratory setting, known as Home Brew tests, or in-house manufacturing. Whilst Home Brew manufacture continues, with the genuine belief that this is saving the NHS valuable resources, it does mean that the product quality may not be controlled to the same high level as required for tests developed and produced by commercial organisations. Thus aspects such as stability, suitability of sample types, cross-reactivity and storage may well not have been considered or investigated thoroughly. This increases the risk that results generated via these methods, and subsequently used as part of the clinician's decision-making process, may be unreliable and could result in harm to the patient.

  1.3  It should not be forgotten that there are tests being produced within the NHS which do not have commercially available alternatives. These are usually at the forefront of science and, while BIVDA would not want access to these tests denied to patients, we believe that some criteria for development and production should be applied before they can be used.

  1.4  The issue of Home Brew has also been a source of concern in other countries. In the USA, two senators introduced legislation, entitled the "Laboratory Test Improvement Act "(2007), to ensure "all providers of "homebrew" laboratory tests provide the Food and Drug Administration with evidence that verifies their analytical and clinical validity". In France there are requirements for producers of Home Brew tests categorized as moderate or high risk to provide information about the test and agreement from a Notified Body before use. There has also been some scrutiny of Home Brew tests used within blood banking by the authorities in Germany.

  1.5  The industry also faces a constant battle against potential misuse of product(s) through changes made to a test procedure not indicated in the product's Instructions for Use (IFU). The industry has made its position very clear on these off-label uses—the products cannot be guaranteed when the IFU is not adhered to. As with Home Brew tests, the reason for off-label use is to minimise NHS expenditure, however this cannot justify the potential risk to patient safety. Worrying examples of off-label use include using half-volumes of reagents, using product past its expiration date, pooling samples before screening for infectious disease (individual samples only being tested if the pooled sample is positive), and replacing validated reagents with Home Brew alternatives etc.

  1.6  BIVDA strongly advocate the introduction of regulation whereby Home Brew tests would be regulated to at least the level as currently seen in the USA and furthermore that off-label use is discontinued within NHS laboratories.


  2.1  It is now taken as normal practice for a woman to purchase a Home Pregnancy Testing kit over the counter to ascertain if she is pregnant before considering consulting a GP. This is because there is overwhelming evidence that these test kits are simple to use and very accurate, even in the earliest stages of pregnancy. Products marketed for home use are also bound by the IVD regulations and it is illegal to place a product on the market in the UK which does not meet the requirements of the regulations. At present, consumers do not recognise the fact that, in the interests of their own safety, they should ensure a self-test kit is CE marked before purchasing it. Unfortunately, many unregulated products are sold to consumers via internet sales and since BIVDA recognises internet selling is largely impossible to police, the requirement for greater, government-funded public education has become essential.

  2.2  In addition to self-test kits, consumers can also obtain results by paying for a Direct To Consumer (DTC) testing service. This involves sending a sample by post to a company who analyse the sample and provide results.

  2.3  Whilst the product used to analyse the sample and the sampling kit supplied to the consumer are each required to comply with IVD regulations, there are no regulations in force relating to control of the organisations supplying the service. It appears that anyone can open a commercial laboratory without any recognised professional scientific qualifications. Indeed there are some BIVDA members who are involved in running such testing services, however our members operate their laboratories to all relevant quality standards such as ISO 17025, at considerable cost and, as such, would welcome legislation to protect consumers from less ethical suppliers.

  2.4  BIVDA's belief is that the consumer's choice to pay for a testing service and interpret the information returned, in the absence of any healthcare professional, puts these services into the arena of self-testing and as such, should be subject to IVD regulation. In the absence of current regulation BIVDA is currently drafting industry guidelines for self-regulation although clearly these will not prevent unethical suppliers from operating in this area.

  2.5  The Medicine and Healthcare products Regulatory Agency (MHRA) are the government organisation responsible for enforcing the IVD regulations. BIVDA believes they should be given additional resource to enable them to address issues relating to consumer purchases and to help them raise awareness of the dangers involved in using non-CE marked products.


Recommendations for improving patient safety related to the use of in vitro diagnostics

  BIVDA believes patient safety could be improved in relation to IVD tests.

  Firstly, Home Brew tests, manufactured within the NHS, should be subject to stricter control and off-label use of commercially provided tests banned within NHS Trusts.

  Secondly, steps should be taken to ensure people are aware that self-test products should be CE marked. As it is unlikely that regulations can be put in place to address purchases via the internet, the MHRA should fulfil a central role in educating the public. Regulations should be developed to control suppliers offering testing related to healthcare direct to consumers.

  For these recommendations to be implemented effectively, the MHRA should be adequately resourced to address additional activity.

  BIVDA would be happy to provide further information, including oral evidence, if the Health Committee feels this would be beneficial to their inquiry.

September 2008

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