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
IVDs are the tests used for:
Early detection or diagnosis of disease,
Screening for disease pre-disposition,
Monitoring of treatment and disease
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. CONCERNS ABOUT
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 usesthe 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. RISKS ASSOCIATED
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
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
BIVDA would be happy to provide further information,
including oral evidence, if the Health Committee feels this would
be beneficial to their inquiry.