RADIATION PROTECTION.html
Radiation protection and the safe use of X-ray equipment: Laws, regulations and responsibilities
Charles P Herbst, PhD
Department of Medical Physics, University of the Free State, Bloemfontein
Gerhard H Fick, DCL
Department of Private Law, University of the Free State
Corresponding author: C Herbst (Gnbich@ufs.ac.za)
Background. South
Africa’s regulatory framework for electromagnetic medical devices has
come under considerable criticism. Here it is reviewed in terms of how
it has given form to protective measures against ionising radiation.
The Hazardous Substances Act provides for effective protection against
radiation, but has been undermined by poor administration and
uncertainty about regulations and licensing conditions. The legal
weight of enforcing licensing conditions through a website without
proper consultation with all parties concerned is questionable and
ineffective. Effective and legal radiation control is possible by
activating the National Advisory Committee on Electronic Products,
provided for in Regulation R326 published in 1979, but this has never
been implemented. The possible impact of annual quality assurance tests
currently enforced through licensing conditions on radiation dosage to
the population is not cost-effective, as new training and accreditation
structures have to be created.
Conclusions. That
more than 80% of overexposures are generally caused by human error is a
clear indication that training of the regular users of X-ray equipment
should be emphasised, and not the training and accreditation of the
technicians responsible for a single quality assurance test per year.
Constructive engagement with the professional bodies involved in the
medical use of X-rays through a National Advisory Committee on
Electronic Products may be a cost-effective solution for lowering
radiation dosage to the population.
S Afr J Rad 2012;16(2):50-54.
Author’s note:
Since completion of this article, the licencing conditions have been
changed again and, moreover, been removed from the website of the
Department of Health, and are now on an independent website at
http://sites.google.com/site/radiationcontroldoh. Revising the article
in its current form to take these developments into account will
lengthen it and delay its publication; but its principle message
– an appeal for implementing an advisory body, as statutorily
provided for – is yet further strengthened.
Introduction
It has been recognised since early studies on
X-rays that exposure to high levels of radiation may cause tissue
damage, and that chronic exposure to lower levels of radiation may
result in cancer. However, the use of X-rays is part and parcel of the
fight against disease and plays an indispensable role in clinical
management of patients. The annual worldwide number of X-ray procedures
has been rapidly increasing, from 1.9 billion in 2000 to 3.1 billion in
2008.1 Over
the same period, the annual collective dose to the world’s
population increased from 2.4 MSv to 4 MSv. Today, electromagnetic
radiation from medical procedures constitutes the single largest
manmade means by which people encounter radiation exposure.2
Protection against the medical use of radiation is therefore even more
important than protection against any other source of radiation.
The innovative use of radiation, and specifically
X-rays, imposes risks if inadequately controlled by suppliers, users
and government. Concerns about the possible effects of exposure to
radiation on the human body were raised to a high level during the
1980s and 1990s, culminating in several international studies3 that proposed basic safety standards to control and limit exposure to such radiation.4
The Department of Health (DoH) in South Africa has, through its
Directorate: Radiation Control (DRC), adopted these standards and
applied excerpts as legal requirements and guidelines. In addition, the
Minister of Health, and specifically the Director-General: National
Health and Population Development (DG), are mandated to administer the
Hazardous Substances Act of 1973 by granting, suspending or revoking
licences to importers, manufacturers and users of electromedical
products (X-rays).5
The licence is issued if the product and usage comply with legislative
and international requirements for safety and performance.
However, in November 2010, the DoH briefed the
Parliamentary Health Portfolio Committee that the administration of
South Africa’s regulatory framework for electromagnetic medical
devices was under considerable pressure as its technical and managerial
competence was impugned by inadequate and insufficiently qualified
personnel6
– fewer even than in Botswana. Accordingly, it is the aim of this
review to determine whether South Africa has in place a sound
legislative framework and effective regulatory infrastructure for
guaranteeing the safe application of radiation and radioactive
substances. This will be done by firstly looking at how the legislature
has given form to protective measures against ionising radiation and,
secondly, discussing the application in practice of Group III hazardous
substance control and the shortcomings of the regulatory
infrastructure. Lastly, recommendations and a possible future path are
set out.
The legal framework for radiation control in South Africa: An historical and critical appraisal
South Africa is considered to have had a relatively
‘good’ system of electro-medical device regulation in
place, which started in 1971. The legislative control of electronic
products was for the first time introduced by the Public Health
Amendment Act of 19717
that added section 133A to the Public Health Act of 1919, allowing the
Minister of Health to make regulations mandating the Secretary of
Health to grant, suspend and revoke licences in respect of electronic
products and prescribe conditions and requirements for the categories
of electronic products, premises and persons in control of the
equipment.
Comprehensive regulations (Regulation R1332)
concerning the use of X-ray equipment in terms of the 1971 Amendment
Act were made in 1973.8
These regulations pertaining to Group III hazardous substances are
still in force, although some uncertainty prevailed after the whole of
section 133A along with the Amendment Act of 1971 (and by implication
also Regulation R1332) were specifically repealed by section 32(1) of
the Hazardous Substances Act, 1973. Superficially viewed, the
uncertainty was reinforced when almost all of the Public Health Act of
1919 and the whole of the Public Health Amendment Act of 1971 were for
a second time repealed, this time by section 63(1) of the Health Act of
1977,9 which in turn was abrogated partially by the National Health Act of 2003,10
omitting any reference to radiation control whatsoever. However,
section 32(2) of the Hazardous Substances Act revived Regulation R1332
indirectly, deeming the latter to have been made under its own reserved
capacity.
Hazardous Substances Act and Regulations
The Hazardous Substances Act (1973)11
prohibits and controls the importation, manufacture, sale, use,
operation, application, modification, disposal or dumping of substances
and (electronic) products that may hurt or kill human beings by reason
of their detrimental direct or side effects. The Act classifies such
substances and products in groups according to the degree of danger.
The Minister of Health, by one of only two ruling regulations issued in
terms of section 29 of the Hazardous Substances Act, listed electronic
products (X-rays) to be a Group III hazardous substance.12
The Act empowers the DG to grant, refuse, amend, suspend or revoke a licence for the use of X-ray equipment.13 These powers may be delegated in writing to ‘any officer of the Department of Health’.14
Current practice is that these powers are executed by the Directorate
of Radiation Control (DRC), but no such authority has been bestowed (by
any statutory stipulation) on the DRC. In fact, the DRC is not a
juristic person and has no locus standi
or legal capacity to take decisions, issue licences, determine
conditions or function on its own. The common idea that the DRC is the
‘regulatory authority’ is not only wrong, but also without
legal foundation.
Section 3(1)c
of the Act prohibits anybody to ‘… install or keep
installed any Group III hazardous substance on any premises …
otherwise than subject to the conditions prescribed or determined [author’s emphasis] by the Director-General.’15
The definition of ‘prescribed’ in Section 1 of the Act
stipulates that ‘prescribed’ means prescribed by
regulations. It is only fair and transparent if conditions are subject
to a process of regulatory consultation. Such a procedure allows public
and interest group scrutiny before the final notification is published
in the Government Gazette. If the DG (or delegate) should
‘determine’ the conditions without a consultation
processes, it may create uncertainty and reinforce the idea of unfair
coercion. There is, however, a time-consuming and probably less
effective legislative escape for the licence holder. If a person is
aggrieved by the decision or condition imposed by the DG, such person
may appeal to the Minister.16
Notwithstanding that there are no regulatory
prescripts regarding inspections, inspectors are appointed and have
powers prescribed by sections 8 and 9 of the Hazardous Substances Act.
In an effort to overcome the insufficient number of inspectors (12
posts in South Africa for more than 6 500 licence holders and 16 000
X-ray machines!),17
the DRC granted permission to Inspection Bodies (IBs) to perform the
required acceptance and annual quality assurance tests of equipment.
Although the intention was that only South African National
Accreditation System (SANAS)-accredited companies would be approved as
an IB, no official reference to this policy could be found.
In general, the control and sale
of listed electronic products are satisfactorily regulated in South
Africa by Regulations R690 of 1989 and R1302 of 1991. As mentioned
above, the use
of listed electronic products is regulated by die-hard Regulation R1332
as well as additional restrictions imposed by licencing conditions.
Licensing conditions for medical X-ray equipment users
Current practice of the DRC when a licence is
issued is to attach licensing conditions as an annexure to the licence,
which usually refers to only two conditions directly but to more
conditions indirectly. The annexure does not contain the licencing
conditions, but refers the licence holder to documents containing the
licensing conditions on the DoH website. These web-based documents
therefore possess legal authority as licence requirements, but may
change without further notice to the licence holder.
The first licensing condition, namely the Code of Practice for Users of Medical X-ray Equipment
18
(hereinafter Code of Practice) (note that the URL on the document is
wrong as it has changed since the last revision), is based on
recommendations of the Australian Radiation Protection and Nuclear
Safety Agency, recommendations (1991, 1996, 2000) of the International
Commission on Radiological Protection (ICRP), and the Code
of the National Radiation Laboratory of the New Zealand Ministry of Health.
Whether the
Code of Practice was first of all subject (if at all) to comment from
the medical radiation community, followed by formal public consultation
and finally approved or adopted by the DG (or delegate), is unclear.
What is clear, however, is that the DRC has no legal status to devise
new requirements or conditions, and the fact that they had been
incorporated in the Code of Practice would be of no consequence.
Furthermore, within the Code of Practice it is stated that ‘This
Code must be read in conjunction with DOH guideline documents as listed
in Annexure A of this Code.’ The guidelines annexed to the Code of Practice are also published on the website and consequently also form part of the licensing conditions.
The second licensing condition usually attached to
a licence enforces annual quality assurance according to a prescribed
list, and is also listed on the website under the guidelines.
Weaknesses in the current legal framework and enforcement of the Act
Poor management, insufficient staffing levels, high
vacancies, outdated data for radiation sources and installations, lack
of financial resources and deficient human regulatory capacity,
undermine a sound radiation protection infrastructure and put the
health and safety of South Africans at risk.
The practice of publishing licensing conditions on
a website as an annexure to an annexure of the licence without a proper
consultation process is questionable, and leads to ambiguities and
inconsistencies in the radiation protection legislature and license
requirements. Potential areas of conflict include the repeal of
regulations and paragraphs from Regulation R 1332 (published after a
consultation process) by the Code of Practice (published without
consultation). Besides the questionable legal basis of the Code of
Practice, unpredictable and ad hoc
requirements/conditions are added randomly, making license compliance
uncertain and may be against basic human rights enshrined in the
Constitution, namely academic freedom,19 the freedom to pursue economic activities,20 and access to healthcare services.
Furthermore, the legal standing of the Inspection
Body is unclear, as neither the Act nor any regulations make provision
for such a body. This fact may have severe consequences in cases where
the results via an IB differ from those of the company responsible for
maintenance of the equipment.
Legal pathway to the future
Is it fair to say that South Africa has failed in
almost every aspect of the IAEA’s safety standards for radiation
safety and infrastructure, apart from the relatively ‘good
regulations’ that are in place?
The constitutional dispensation
The State has the obligation to take steps to
acknowledge the socio-economic rights of all individuals so that they
may be pursued to the optimum. These steps include legislative
frameworks within which individuals can exercise their rights. The
Constitution specifically makes provision for the right of access to
healthcare services,21 in which area the State has been extremely active.22 Since 1994, more than 40 pieces of legislation have been promulgated under the auspices of the Minister of Health23
– yet we still rely on the outdated regulation R1332 of 1971 to
protect users and patients against the serious risk of radiation
effects.
The revival or creation of a regulatory authority – currently and in the future
In view of the inability of the DoH, its division
(the DRC) and the DG to administer the provisions of the Hazardous
Substances Act (and regulations) effectively, it remains to be answered
how the situation can be speedily turned around.
The Hazardous Substances Act provides adequate
measures for ensuring public safety; but the administration of the Act
leaves much to be desired. The uncertainty about Regulation R1332, lack
of proper regulations, and discrepancies between existing regulations
and licensing conditions may be addressed within a framework that has
already been created, but not put into operation.
The National Advisory Committee in terms of the Hazardous Substances Act
Regulation R326 of 1979, published under this Act,
provides for a statutory legal entity, known as the National Advisory
Committee on Electronic Products,24
but nothing has been realised. The Committee was to function as,
firstly, an advisory body to the DG and, secondly, as a research
facility to engage with international institutions in an effort to
combat the dangers associated with electronic products.25
By not instituting an informed, independent and statutory body, the
valuable opportunity was lost to promote safety standards and proactive
management performance. The creation of the Committee, though, is still
latent and remains captured in the 1979 regulation for urgent
implementation. This National Advisory Committee on Electronic Products
could and should play a pivotal role in all future radiation control
requirements.
The contemplated South African Health Products Regulatory Authority in terms of the Medicines and Related Substances Amendment Act, 2008
After a relatively long, shaky and controversial
beginning, the Medicines and Related Substances Amendment Act of 2008
was assented to on 19 April 2009.26
Although the Act has yet to come into operation, the new regulator (the
South African Health Products Regulatory Authority (SAHPRA))was
expected to have started functioning in April 2012 and is destined to
replace the Medicines Control Council (MCC).27
The main aim of the Act (2008) is to register medicines, products,
medical devices, certain foodstuffs and cosmetics. Although the
definition of ‘product’28 in the 2008 Act is too narrow to involve radiation equipment and sources, the definition of ‘medical device’,29
however, is broad enough to do so. In this way, the SAHPRA may become
the regulatory authority for X-ray equipment and radioactive substances
as well. Recent indications are that this is precisely what is
contemplated as a panacea. The radiation inspectorate is bound for
absorption in some way or another into the designated SAHPRA under the
Medicines and Related Substances Act of 1965 (as amended in 200830 ).
This possible
accommodation will involve a second act without any current regulations
controlling the use of X-ray equipment. In view of the administrative
inability of the DRC to function under a single act, it is hard to
foresee that the new amendment will relieve any of the problems
encountered, inter alia lack
of regulations, lack of a consultative process, and lack of a
management system referred to above. The solution may very well lie on
another level.
Responsible use of radiation equipment
The strong enforcement of licensing conditions that
were set without public consultation, and the lack of communication
between the ‘regulator’ and users of radiation equipment,
have created a confrontational culture. The strong enforcement of
conditions may also lead to a false sense of security on the side of
users, as enforcement of the restrictions of the licensing conditions
is regarded as sufficient radiation control. This is counter-productive
as the unfortunate reality is that approximately 80% of overexposures
in radiology are caused by human error.11
,
31
The 20% of overexposures caused by faulty equipment are mostly caused
by intermittent AEC failure or breakdown of equipment during complex
radiological procedures.
If we are really concerned about exposure levels to
staff, patients and the public, the problem should be addressed at
source, i.e. human incompetency.
The use of medical X-ray equipment should be
restricted by regulation (not licensing conditions) to professionals
registered with the HPCSA and appropriately trained in those aspects of
imaging or therapy and safety relevant to their clinical role in order
to limit overexposures caused by human error. This will bring us in
line with other countries (e.g. Australia,32 Canada,33 the European Community34 ) as well as recent recommendations by the radiological community of the United States35
that acknowledge the importance of human competency in radiation
protection and where each user of a machine must be certified to do so.
Constructive engagement with the HPCSA and professional bodies may set
the required standards and ensure that current and potential future
users (surgeons, cardiologists, urologists etc.) will have the
necessary skills and knowledge to perform their duties with minimal
risk to patients, the public and personnel.
By engaging with the professional bodies, high-risk areas can be identified. In 2008, for example, CT examinations accounted for 80% of the total Norwegian population’s medical radiation exposure.36 Similar trends were observed in the USA.37 By
concentrating on high-risk areas, manpower can be utilised more
effectively (and no increase in cost) with a marked impact on the
population’s cumulative radiation dosage.
The unwillingness to engage with existing
professional bodies about including radiation protection as a
prerequisite for registration/certification is in sharp contrast to the
very active engagement with SANAS for setting standards and creating a
previously non-existing accreditation body that will accredit IBs. An
irony is that the impact of the financial burden concentrating on
quality assurance of equipment once per year may be insignificant to
the radiation dose of the population at large, as equipment-related
over-exposures will not be prevented nor reduced by the annual quality
assurance imposed by the licensing conditions.
Conclusion
As pointed out above, the Hazardous Substances Act
provides adequately for regulatory measures to ensure public safety,
but the administration of the Act leaves much to be desired.
The National Advisory Committee on Electronic
Products Committee should be constituted by the Minister as soon as
possible to investigate and rectify the uncertainties and discrepancies
pointed out above. The committee should include radiologists,medical
physicists, radiation biologists, radiographers, the HPCSA and
equipment suppliers. The constructive engagement between the DRC, the
HPCSA, the radiological community of South Africa and other roleplayers
will ensure appropriate regulations with correct terminology and
unambiguous interpretation that will conform to legal requirements.
By the appropriate sharing of the responsibility
for radiation protection with professionals registered with the HPCSA,
the burden on the understaffed directorate will also be alleviated by
concentrating on high-risk areas identified and agreed upon within a
properly constituted National Advisory Committee on Radiation
Equipment. Until that time, the danger will remain that the current
situation may be legally challenged by an affected party.
One might summarise the situation by saying that
inadequate personnel (in numbers as well as competency) are using
obsolete legislation and control measures to protect the public against
the most important source of radiation. The situation will be rectified
by actively engaging the trained professionals primarily and routinely
responsible for radiation, under the auspices of the HPCSA, and to use
their professional expertise within a National Advisory Committee on
Radiation Equipment to identify the highest risk areas to be addressed
by appropriate legislation and other measures.
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