Sound advice – medical imaging regulation

1 December 2016



A series of regulatory measures have been launched to cope with the increasingly intense scrutiny to which medical imaging services are being subjected. Nick Dudley, from the British Medical Ultrasound Service, explains to Andrew Putwain how they will ensure that staff are properly trained, as well as guaranteeing the safety of those using the service.


With the advent of The Royal College of Radiologists (RCR) Imaging Services Accreditation Scheme (ISAS) and the Care Quality Commission (CQC) inspections specifically reviewing imaging services there has never been more help out there to help – and confuse – anyone who works with ultrasound.

Many of those working in MRIs and medical imaging require advice and practical experience in the key aspects of governance and quality measures in ultrasound to get by with the constantly changing regulations.

At the same time, the medical sector is under pressure like never before. In the UK, the National Health Service has been pared to the bone by (among other things) government austerity cuts, and one of the biggest problems this is has caused is low worker morale: hospitals and health boards are unable to recruit, or retain, staff in the face of a widespread exodus.

On your side

Dr Nick Dudley is the principal physicist for the medical physics department at the UK’s Lincoln County Hospital. He chaired the 2015 Scientific Organising Committee for The British Medical Ultrasound Society (BMUS) Council and has been on the education and scientific committee for three years.

Dudley is also a serving member of the BMUS Council and co-authored the BMUS Guidelines for the Regular Quality Assurance Testing of Ultrasound Scanners by Sonographers. Dudley has been working in medical imaging for more than 30 years and his main area of focus is equipment and monitoring it for safety.

“I’m quite concerned about the quality of the equipment,” he admits. “A colleague and I did a survey of ultrasound equipment and found that one in eight ultrasound probes wasn’t fit for use because of deterioration or damage, and a third needed attention because of some sort of fault. We’re trying to address that, and the next issue of the professional practice guidelines from BMUS will have advice about looking after and testing your probes. The range of staff using them has got quite broad.”

I did a survey of ultrasound equipment and found that one in eight probes wasn’t fit for use because of deterioration or damage.

The BMUS quality assurance (QA) testing is designed to help those working in the sector, but much trepidation remain around the constant compliance and safety changes.

“BMUS is a charity,” Dudley explains. “It’s trying to promote ultrasound standards. Its members are people who are involved in ultrasound in some way, and the organisation promotes standards among them, and they support other groups who might also use ultrasound. Ultrasound is used all over the medical field now: it used to be concentrated in radiology departments, but now it’s used in most departments within hospitals.”

This is where many of the needs for having new guidelines come in and why BMUS, the RCR and other bodies want proper care and use to be monitored and encouraged in the sector.

Dudley has published several research papers on quality assurance in ultrasound devices. He argues that it is necessary “to ensure the reliability of results and to check for deterioration in performance”.

Many medical bodies have now produced their own guidelines to protect themselves from possible fallout from the recent strain placed on the NHS, and to improve general care, and help their members develop professionally.

In his papers, Dudley says that, while testing has traditionally been the responsibility of medical physics departments, the important role of sonographers has now been recognised, and the BMUS QA was established to provide a consistent set of guidelines specifically for them.

These cover three levels of recommended testing: infection control and inspections for scanner and probe damage; basic display checks and further tests to assess drop-out; and sensitivity and noise on the machines and all other technological devices. The literature states that these tests should form part of a programme that includes more comprehensive testing at longer intervals.

New guidelines

In 2015, the BMUS Professional Standards Group produced new guidance documents to assist ultrasound providers with vetting primary care referrals for ultrasound. The document was produced to “support departments to make best use of their resources and to help ensure only appropriate referrals are accepted”.

The provision of Ultrasound QA across the UK is depends on the provider and the usage involved. In some areas, a comprehensive service is provided, but many clinical services have no formal programme.

In the latter scenario, it might be expected that ultrasound users would report and ensure repair of obvious faults, such as mechanical damage, but anecdotal evidence from around the country shows that this is not always the case. On many modern scanners, faults are masked by advanced processing.

The implementation of QA has also been inconsistent. There are many possible reasons for this, including the lack of a legislative requirement, availability of medical physics services, sonography workload and a view that formal QA is unnecessary.

When asked what specific guidelines he sees as being important and how he wants them to raise standards, teach users and increase safety, Dudley points out that most were written for those working specifically with ultrasound, and the scope must now be broadened.

“BMUS has regularly updated guidelines for professional ultrasound practice,” Dudley says. “The members appreciate the guidance on clinical practice, but it’s important that we also offer guidance on things around that; BMUS does a lot of educational work on governance.”

Clinical care is seen as vitally important, but members also frequently ask about bureaucracy, compliance and regulatory issues. One of the main areas of concern is audits. “They’re promoting audits a lot, at the moment. And providing guidance on reporting, because the report that comes out of an ultrasound scan is very important: it’s got to be something that the referring doctor can interpret and use to decide on a patient’s diagnosis and treatment. It’s vital to have consistent style.”

RCR and all that

Making the best use of clinical radiology services is now an official guideline and heavily built upon in the clinical care strategies of the networks. The Royal College of Radiologists (RCR), in conjunction with BMUS, has developed a programme called iRefer to address the process of choosing the correct test at the right time.

The RCR hopes this will help ensure patients receive timely and accurate diagnoses, reduce unnecessary exposure to radiation and ensure the efficient and even use of available diagnostic resources.

iRefer is an evidence-based system of referral guidelines designed to help radiological investigation.

These guidelines include using “early exclusion of serious pathology reassures and empowers patients and referring clinicians; for the radiography to make a prompt diagnosis that will lead to the patient having the most appropriate treatment – and by swiftly moving on from the working diagnosis to a more definitive diagnosis.”

“There are links between BMUS and the Royal College of Radiologists, some BMUS members sit on RCR special interest groups, so there are links there and there were BMUS members involved in writing the RCR guidelines,” says Dudley. “We all work in the same direction; the RCR fellowship guidelines give a sort of high-level guidance on what’s required, and BMUS provides the detail.”

The RCR is providing overarching, almost ‘executive-level’ advice, while BMUS deals more in everyday support and help. “BMUS tries to to tell people how to do things, while the RCR tells people what it thinks they should do.” Dudley explains.

The next direction

“We produce guidelines, we can’t actually make these changes ourselves, because we don’t have authority,” Dudley says, “but what we can do is try to influence, and one of the problems at the moment is a lack of staff.

Sonography workload is a growing issue for QA services, affecting sonographer engagement and access to equipment.

“There aren’t enough sonographers, and sonography education is a hot topic at the moment. Health Education England is looking at it and BMUS is trying to exert its influence. It surveyed their members to find out what they thought about sonography education, and will be feeding that to Health Education England, hoping that something good comes from it.”

Literature supplied by BMUS and RCR shows that legislation is far from perfect, and that while their guidelines might be helpful, they often go unheeded. The rules are designed to protect staff, patients and members of the public from the effects of radiation, but the enforcing bodies expect them to include assessment of image quality, as well as radiation dose.

“Sonography workload is a growing issue for QA services, affecting sonographer engagement and access to equipment, asserts Dudley. “In addition to anecdotal reports of the failure of some users to report and remedy obvious faults, there is increasing evidence in the literature of the efficacy of formal QA programmes identifying more subtle deterioration of imaging performance.”

By signing off a report, sonographers are certifying that their equipment is fit for purpose.

Key to consistency

The importance of guidelines for diagnostic equipment has been recognised by several bodies. “The aim of these is to empower sonographers to take a role in demonstrating the consistency of performance of their equipment for the benefit of their patients,” concludes Dudley.

The BMUS guidelines are made with staff and patients in mind, and anyone working in this increasingly complex industry could benefit from the insight they provide. 

Quality of equipment will be subject to increased scrutiny under new regulatory measures.
Dr Nick Dudley has worked in medical physics since 1979. He has previously been head of imaging sciences at Nottingham City Hospital and has also held an honorary appointment as visiting senior research fellow at the University of Derby. In 2003 he was awarded a PhD in ultrasound on the basis of publications.
The guidelines are designed to protect sonography staff and patients from excessive exposure to radiation.


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