Diagnostics
The prognosis for diagnostic services
To cope with the challenges of the future, it is critical to optimise diagnostic services and enable faster and earlier testing. Tracey Sainsbury discusses the key challenges and opportunities ahead
Rapid and efficient disease identification is a pressing issue for the healthcare sector. Earlier diagnosis of infectious diseases can reduce transmission, improve patient quality of life and reduce some of the burden on healthcare services – a phenomenon that was observed on a global scale during the COVID-19 pandemic. The diagnostics sector is also contending with rising cases of chronic diseases, an ageing population and staff shortages in healthcare. This increased demand for diagnostic services predates the pandemic. Factors such a rise in hospital attendance and more direct requests for tests from GPs were already driving demand in the UK.1
This heightened pressure means that
six week waits for diagnostics in pathology have risen by 17% per year since 2010.2 Laboratories globally are also contending
with other pressures. The surging demand for their services during the pandemic absorbed higher volumes of supply, leading to ongoing shortages.3-7
To allow manufacturers breathing
timeframe to comply, while the final deadline for lower risk devices falls in May 2027.9
The
ability of manufacturers in the EU to meet the new requirements in time will impact laboratory supply, since non-compliant devices may have to be temporarily or permanently withdrawn. One estimate is that at least 22% of IVD tests on the market today will be discontinued.10 Additionally, staff shortages which are common to wider health services are affecting diagnostics. A census by the Royal College of Pathologists in the UK found that that only 3% of histopathology departments in the National Health Service have enough staff to meet clinical demand,11
while the Royal College
of Radiologists (RCR) reported in 2016 that nearly 97% of the UK’s radiology departments were unable to meet diagnostic reporting requirements.12
In the US, the level of training In the EU, the In Vitro Diagnostics
Regulation, which came into force in May 2022, entails much stricter requirements for 85%-90% of IVDs.8
room to achieve compliance, the regulation is being rolled out progressively based on device classification. Higher risk devices have a shorter
required for phlebotomists is proving an obstacle to meeting surging demand for blood collection, expected to increase by double-digit percentages over the next few years.13 The COVID-19 pandemic exacerbated pressure on diagnostic services, but also highlighted the value of an agile diagnostic testing sector,14 changing attitudes towards digital solutions. These changes in perspective may help to
speed up efficiency measures. With non- communicable diseases accounting for 71% of all deaths globally,15
urgent action is needed
to improve service delivery and ultimately reduce morbidity and mortality through earlier and more efficient testing. One solution is to introduce more community phlebotomy services and diagnostic hubs with improved services. Additionally, user-centric equipment suitable for use in a wide range of settings and for a range of skill sets is integral to efficient diagnosis.
Taking testing local Community phlebotomy services and diagnostic hubs allow faster access to diagnostic testing since patients can be referred directly to local diagnostic services rather than hospitals, where waiting times are likely to be long. NHS England announced the creation of 40 new community diagnostic centres with these aims in mind, and to help reduce the backlog caused by the pandemic.16 For blood sampling, the Independent Review of Diagnostic Services recommends that all patients should have access to community phlebotomy services close to their homes, at least six days a week, without needing to visit acute hospitals.17 Progress is therefore underway, but there is
still more to be done before community hubs are widespread. An emerging concept – notably in Italy and the US – is the ‘medical village’ or ‘polyclinic’, a medical community of GPs, specialists, nurses, diagnosticians, and even dentists. The team is often based in shopping or community centres, offering easier access to specialists, in a single location.18
Similarly,
some European laboratories provide access to knowledgeable doctors, who can advise on treatment and whether further testing is needed. This is also an efficient way to deploy highly experienced laboratory staff.19
User-focused diagnostic tools Diagnostics professionals need the support of user-centric tools that aid productivity. 70%
February 2023 I
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