Since the last RP News was published in April 2007, The Medicines and Healthcare products Regulatory Agency (MHRA) have published DB 2007(03) ‘Safety Guidelines for Magnetic Resonance Imaging Equipment in Clinical Use’ and Device Bulletin DB2008(03) entitled ‘Guidance on the safe use of lasers, intense light source systems and LEDs in medical, surgical, dental and aesthetic practices’. Both are available to download from www.mhra.gov.uk
One of the outcomes of the SRP seminar and workshop on the Transport of Radioactive Materials that took place in Birmingham on 1st November 2007 was that many delegates felt that there remains a problem regarding the security of deliveries of radioactive materials, particularly routine deliveries and collections (such as Tc-99m generators) often when this occurs outside normal working hours. Following inspections carried out as part of our hospital inspection programme in 2002/03, HSE initially aired its concerns about this topic in RP News, Issue 23, May 2003 (www.hse.gov.uk/radiation/ionising/rpa/rpa23.htm).
As described in a subsequent RP News [Issue 26, November 2004 http://www.hse.gov.uk/radiation/ionising/rpa/rpa26.htm#health] a meeting between UK regulators, manufacturers and representatives of the relevant professional bodies subsequently took place. The outcome of this was that the British Nuclear Medicine Society (BNMS), British Institute of Radiology (BIR), and the Institute of Physics and Engineering in Medicine (IPEM) undertook to produce some joint guidance. This guidance, reviewed by the HSE, EA, and a CTSA, was published in Nuclear Medicine Communications as referenced below.
Lawson RS, Davies G, Hesslewood SR, Hinton PJ and Maxwell A.
Delivery and collection of radioactive packages to and from UK hospital nuclear medicine departments.
Nuclear Medicine Communications :Volume 25(12) December 2004 pp 1161-1167
The seminar and workshop was organised by the SRP Non-Nuclear Sectorial Committee and they have subsequently asked HSE to highlight this issue in relation to potential non-compliance with IRR99 and raise awareness of published guidance. Although HSE inspections indicated a significant increase in regulatory compliance in this area during 2004 and 2005, it may be the case that some Nuclear Medicine Departments have yet to take onboard this guidance. Rumours remain of unacceptable practices such as delivery drivers leaving the packages with receptionists or in corridors, or having direct access to radioactive material stores, and hospitals not taking immediate ownership of the radioactive materials.
On 12th November 2007 the HPA and British Geological Survey jointly published new information on radon affected areas in England and Wales. The data available are very detailed and so an indicative atlas, which provides an overview of the data, has been produced. The new data replace those described in the previous report NRPB-W26 (2002) and are available from www.ukradon.org. A copy of the atlas (HPA-RPD-033) can be purchased or freely downloaded from www.ukradon.org/services/.
The HSE Radiation Team hosted an open space meeting on 31 October 2007 based around the central theme of ‘Medical and dental radiation protection - the practicalities of IRR99 compliance’. The meeting was well- attended by a wide range of participants including: medical and dental RPAs, medical physicists, regulators, representatives from equipment manufacturers/suppliers and others with a general interest in medical and dental radiation protection. The meeting was held in an ‘open space’ format, which enabled participants to set their own meeting agenda by suggesting topics and items for discussion. It was obvious that participants were fully prepared for the meeting judging by the large number of topics posted for discussion, which resulted in lively and interesting debate.
Topics included: problems with wearing and returning dosemeters; management of contractors; QA tests after servicing and repair; employers’ and RPAs’ responsibilities; licensing of X-ray equipment; designation of controlled areas and contamination control in nuclear medicine departments, and the provision of warning signs for radiation controlled areas in dental practice.
The Radiation Team intend to review the session summary reports in early 2008, which may result in the production of additional guidance etc. Details of any further actions arising from the meeting will be published in RP News - watch this space!
Overall, the feedback from the day was very positive with participants welcoming the opportunity to discuss medical and dental IRR99 compliance issues with peers (and regulators!) in an informal and open setting .
The radiation legislation that HSE has responsibility for enforcing requires different types of notifications to be made by dutyholders to HSE. A dedicated administration team based in HSE’s East Grinstead office have been handling all site radiography notifications since 2003. However, from February 2007, all other statutory radiation notifications made in relation to work carried out on non-nuclear licensed sites in accordance with IRR99 or indeed REPPIR have been processed here too.
If you need to submit ‘radiation’ notifications to HSE, please send these by email to email@example.com. Alternatively, if your application and any supporting documentation cannot be sent by email, please contact us at firstname.lastname@example.org and we will make arrangements for a postal application. [Site radiography notifications should continue to be sent by email to email@example.com The same postal address & fax numbers as listed above are applicable for site radiography notifications too.]
The information you provide is checked to ensure it is complete, and that it meets the requirements of legislation i.e. 28 days notice is being provided for IRR99 Regulation 6(2) notifications for instance. Details are recorded on a database and then information is forwarded to the relevant member of HSE Radiation Team for their information and action as necessary. A brief acknowledgement of the notification’s receipt is available on request.
If you have submitted a ‘radiation’ notification directly to either your nearest HSE Radiation Specialist, or to your local HSE office after February 2007 , it will already have been forwarded to the administrative team in East Grinstead so no further action is necessary.
There is a requirement under Regulation 32 of IRR99 to report to HSE medical exposures that have arisen as a consequence of equipment failure or malfunction, and which it is suspected have resulted in radiation exposure to a patient which is much greater than intended. [PM77 (third edition) ‘Equipment used in connection with medical exposure’ available free at www.hse.gov.uk/pubns/guidance/pm77.htm provides further detailed guidance on this issue. ]
Of concern to HSE is the issue of potential under-reporting of these events. Analysis of incidents indicates that there are centres that report events routinely and yet there are great swathes of the country which include major population centres which never seem to experience any form of equipment failure. There does not appear to be any obvious equipment-related link to reporting patterns. In Scotland for instance in the last ten years, notifications for 11 events which resulted in patient exposures much greater than intended have been received from 5 different Health Boards (or their predecessors, NHS Trusts) in accordance with IRR99 Regulation 32 requirements, all of which are served by the same group of individuals acting as their Radiation Protection Advisers (RPAs). There have been no reports from 9 other employers working routinely in the medical sector. Is this just coincidence?
It is important that HSE hears of relevant incidents ‘forthwith’ i.e. immediately after the initial investigation carried out by the ‘radiation employer’, unless this shows that an equipment defect or malfunction did not occur. Upon notification, there is a requirement for the dutyholder to undertake a detailed investigation of events and make an investigation report. The purpose of the investigation process is to establish what happened, to identify the defect or malfunction and its causes, decide on remedial action to prevent a recurrence, and estimate relevant doses received by those involved.
There have been discussions within HSE’s Radiation Team on ways of investigating this issue. Raising awareness of legal requirements is always useful so an article here is a starting point. Inspectors will also continue to raise this topic during the course of routine radiation inspection work, as has been the case over recent years. Consideration is also currently being given to approaching equipment service engineers to request information relating to equipment fault ‘call-outs’ that they have responded to, and which have resulted in excessive exposure. Similarly, approaches to reporting authorities such as Scottish Healthcare Supplies (SHS) and the Medicines and Healthcare products Regulatory Agency (MHRA) may yield further useful information. This would give a more reliable indication of compliance levels, and open the door to taking enforcement action against those dutyholders who decide, for whatever reason, not to make the necessary notifications to HSE.
[Please submit relevant notifications by email to firstname.lastname@example.org. Alternatively, if your application and any supporting documentation cannot be sent by email, please contact us at email@example.com and we will make arrangements for a postal application].
The 30th April 2008 was the transposition date originally set following the adoption of the Physical Agents (EMF) Directive in April 2004 (Directive 2004/40/EC on the minimum health and safety requirements regarding exposure of workers to the risks arising from physical agents (electromagnetic fields) refers in full). The full text is available at www.hse.gov.uk/radiation/nonionising/184emf.pdf)
The European Commission has now postponed the deadline for introducing legislation on workers’ exposure to electromagnetic fields until 30th April 2012. The Commission has commented that this will "allow enough time to prepare a substantive amendment to the Directive in order to take account of recent research findings on the possible impact of the exposure limits on MRI." Interested parties may wish to refer to www.europa.eu for the latest detailed commentary from the European Commission on the reasons for this decision.
RP News and HSE's Euronews site at www.hse.gov.uk/aboutus/europe/euronews.htm will be updated to reflect any significant developments.
For the latest information on enforcement action taken by the HSE Radiation Team, you may wish to refer to HSE’s prosecutions and notices databases accessible via www.hse.gov.uk/enforce/index.htm . ‘Advanced’ searching will allow you to select the legislation of interest in the ‘search item’ field i.e. IRR99.