Select Committee on Health Written Evidence


Memorandum by the British Institute of Radiology (PS 46)

PATIENT SAFETY

  The British Institute of Radiology is very pleased to be asked to comment on these terms of reference and is happy to provide the enclosed summary. These have been synthesised from input received from across our committees, and focus mainly on issues surrounding the use ionising and non-ionising radiation in medicine.

  The BIR is a multidisciplinary organisation and can call on members in all professions involved in radiology (imaging) and radiotherapy. We would be pleased to act as a source of further advice through this inquiry as appropriate.

1.  WHAT ARE THE RISKS TO PATIENT SAFETY AND TO WHAT EXTENT ARE THEY AVOIDABLE ?

Comments in relation to the use of ionising radiation for imaging and treatment

  Medical radiation exposures are perhaps an unusual case in that there is legislation aimed specifically at patient safety. IR(ME)R procedures go some way to decrease these risks but it is clear that common mistakes such as requesting an imaging test for the wrong patient will continue. However, evidence from the HCC report and within Healthcare organisations suggests that such incidents are rare and the radiation doses involved are unlikely to have a significant detrimental effect on the patient. It is important to get risks and consequences into context.

  In some circumstances we have concerns about the concept of "risk free" rather than risk assessment and management. To take an example of radiopharmaceutical preparation, the MHRA and other organisations have, for a number of years, concentrated on minimising risk rather than taking an objective overview of cost benefit. The result has been a large expenditure at improving facilities with little objective assessment of the likely benefits when the risk of contaminated products is already extremely low.

  In, contrast, in radiotherapy the BIR has recently collaborated on advice aimed to improve patient safety, even though error rates in radiotherapy are already extremely low. The document Towards Safer Radiotherapy and subsequent guidance on in-vivo dosimetry has been recommended by us because we took the view that on balance patients were best served by this heightened focus on safety in radiotherapy departments. As well as the seriousness of over or under-dose for an individual patient, adverse press coverage of any accidents have detrimental impact on patient acceptance of this very effective and cost-effective treatment for cancer as well as on staff morale (and therefore on the ability to recruit and retain staff in this important area).

  In general, it is important to obtain a balance between the current level of risk and the effects of more complex systems to decrease the risk. As an example, it may be possible to decrease the number of inappropriate and incorrect x-ray imaging requests by obtaining the consultant's signature on each and every request-form. This would however have a significant detrimental effect on patient care by wasting valuable resources.

  We are not convinced that the "precautionary principle" is appropriate in patient radiation protection or, indeed, in health care. The precautionary principle is applicable in areas where there are reasonable grounds for concern that an activity could cause harm but where there is uncertainty about the risk and degree of harm. This may be applicable in environmental or public health questions, but in radiation protection the level or risk and the degree of harm is well understood.

  In general we would note that perceptions of the level of risk are often completely at odds with objective measures of those same risks

Comments in relation to MRI and patient safety

  Magnetic Resonance Imaging (MRI) has theoretical inherent risks to patient safety as a consequence of the use of very strong magnetic and electromagnetic fields. Possible risks include the movement of free and implanted ferromagnetic objects, the heating of body tissues and implanted metallic objects within the body and the stimulation of nerve tissue via the switching of externally applied magnetic fields. In practice however MRI is a very safe procedure as a result of system controls set by the equipment manufacturer (and defined by International Electrotechnical Commission (IEC) standards and a safety framework of working procedures and patient safety criteria set by UK guidelines from the Health Protection Agency (HPA), the Medicines and Healthcare products Regulatory Agency (MHRA) and various professional groups. The achieved level of safety is as a consequence of collaboration and cooperation between government organisations and specialist bodies, professional diligence by individuals associated with the imaging of patients and a culture of training and expertise within the scientific, clinical and radiographic groups involved in MRI. Essentially a culture exits of an expectation that all users of MRI should meet a model of best practice fostered by government agencies and professional bodies.

2.  WHAT THE CURRENT EFFECTIVENESS IS OF THE FOLLOWING IN ENSURING PATIENT SAFETY

  The value of "near miss" reporting should be assessed and its role in decreasing risk. Simple systems are vital to ensure that busy staff can be encouraged to report simple near-misses. The current IR1 form discourages this.

  We have doubts about the value of national targets. These can lead to a management culture of, for example, deeming it acceptable if there is one case below the target and unacceptable if there is one case over.

  Any framework that is set up to manage the safety of patients will to some extent rely on the fact that individuals follow procedures and processes and from time to time make sound judgements based up on knowledge and experience. In relation to ionising radiation the safety framework is enshrined in law. In relation to MRI the safety framework, which is defined within various guidance documentation, is structured with a reliance on the appropriate training of various groups who fulfil differing roles. Within the NHS there exists a strong, longstanding, ethos of ensuring appropriately trained individuals are associated with the necessary roles of responsibility. It is essential that this ethos is maintained and propagated effectively through a variety of organisations that are emerging with a role in medical imaging and treatment (eg. Primary Care Trusts and the private sector healthcare providers).

  The promotion of an appropriate safety culture and awareness amongst healthcare workers, scientists and clinicians is primarily nurtured by the generation and updating of safety guidance and the associated knowledge base of safety issues. The British Institute of Radiology, along with other professional bodies and colleges organise a variety of scientific and clinical meetings which include the subject of Ionising Radiation and MR safety. These meetings act as a resource to educate and update healthcare workers in safety issues and form part of the continuing professional development of the various groups associated with these disciplines.

  It should be noted that clinical users of Ionising Radiation and MRI equipment have a responsibility of informing the MHRA and HSE of any equipment related safety incidents and the National Patient Safety Agency (NPSA) of all patient safety incidents. Records therefore exist of notified patient safety related incidents.

3.  WHAT THE NHS SHOULD DO REGARDING PATIENT SAFETY ?

General Comments

  We support the concept of improving patient safety based on adequate evidence of effectiveness. The recent "deep clean" is an example where there does not appear to be objective evidence for an expensive NHS wide action.

  Simple systems for reporting incidents would ensure the availability of better data.

  We would suggest that guidance on "best practice" is disseminated with evidence demonstrating its value or references to allow a closer look at the data. Health service professionals are more likely to take note. Professional bodies such as the BIR should have a role in both the generation and dissemination of such advice.

Comment in relation to MRI and patient safety

  The British Institute of Radiology has set up and hosts a multi-agency and multi-disciplinary working party to cover MR safety. The working party brings together all the key government, professional and industrial groups associated with MR safety matters. Indeed the working party has recently highlighted an absence of a resource within the UK for identifying if implanted medical devices within patients are MR safe. The majority of MR sites in the UK make use of an American website which collates data on the testing of devices and identifies which are MR safe, MR conditional or MR unsafe. The implications of scanning a patient with a MR unsafe device implanted within the body are severe and could result in severe injury or death. The only similar resource that has previously existed within the UK has been the Heart Valve Registry, which collated data on the compatibility of implanted heart valves and maintained a list of serial numbers of devices inserted into patients to allow their compatibility to be assessed if such a patient was referred for an MRI scan. The funding for this resource was withdrawn in 2007 and currently there is no data other than that in the USA which MRI sites can use to establish if devices are MR safe. The working party see this is a significant flaw and risk, since clinical sites do not have access to an appropriate data source to quickly establish the safety of an implanted device. Often a long winded process is required via the device manufacturer and the clinical notes and hospital site that performed the insertion to ascertain if a particular patient is safe to undergo an MRI scan. The national targets for patient pathways place significant pressures on the ability to obtain the necessary information in a timely manner.

General comments on training, restrictions and financial constraint

  To maintain an effective level of patient (and staff) safety in all areas of interest to the British Institute of Radiology it is essential that funding is available for the continuing training and education all healthcare groups working closely with this highly complex equipment. It is also essential that the various professional bodies (including the BIR) continue to collaborate with the government agencies responsible for defining safety guidance and for reviewing the science of safety as technology develops. The professional bodies and colleges are often the route for dissemination of information and for promoting an awareness of safety issues within hospitals and institutions. An effective inspection regimen via the Health and Safety Executive and via the Healthcare Commission helps to maintain awareness and vigilance. It important to recognise that often to achieve the highest of safety standards it may be necessary to impact on perceived fiscal and efficiency targets. There may be a risk in the future that a drive to image or treat more patients in a shorter timescale, without an investment in scanning or treatment resources (including staff training) and a recognition of the need for an effective safety framework, could directly impact on the number of untoward incidents.

  We would note that the combined effects of waiting-time directives and financial constraint mean that staff time and budgets for study-leave and therefore for continuing professional development are under pressure as never before. We are in danger of constraining staff training at a time when it is of greatest importance because of the speed of technological change in imaging and radiotherapy. It is hard to believe that the current restrictions are sustainable long-term.

September 2008






 
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