Parastomal hernia: Quality of life
23 March 2023
14 June 2022Read paper
In recent years there has been an increasing focus on the evaluation of medical devices. Approval of medical devices for clinical use is approached in a different way from medicines; they require a demonstration of safety when implanted, but require little in the way of prospective evidence for their efficacy. Once a device is approved by a regulatory authority it can be used by clinicians without mandate for further research or audit on the product. This has inevitably led to manufacturers marketing their products to clinicians, often with little or no published evidence as to their efficacy. Historically, the introduction of devices following regulatory approval has taken a path many of us would have witnessed; a few early adopters work with the manufacturer to develop a small series, often in multiple centres, in a disjointed manner. Hence, over time a novel device may be supported by several small case series, performed in potentially biased sites. These series are often reported with inconsistent outcome measures and differing methodology. The majority of these studies would not have a control group for comparison, making it difficult to establish the true benefits or harms of this novel device.
This approach has inherent drawbacks for both manufacturers, and for surgeons and patients. Manufacturers may often support a series of small studies at moderate cost, which can be slow to deliver and/or be published. The data generated are often not directly comparable or able to be analysed collectively. With regards to patients; Is it right to place a device for which you have no outcome data? Is it right to place a device without consenting that you are new to using this device, with little known about its outcomes? Lastly, why would surgeons use a novel device with little evidence base? There are clearly a multitude of reasons; the device may be an improvement from established practice, there may be pressure from manufacturers, and they may be driven by the desire to be the first to use a device, along with the potential kudos for publishing or presenting on the subject.
The iBRA-NET was established to find a better way of evaluating devices new to the market. As a collaborative group we wished to establish a framework for research and audit of outcomes of new devices, with a robust governance structure. There was an imperative need to study localisation devices for impalpable breast cancers, due to their rapid introduction into the clinical setting, and the relatively short-term follow-up requirements meant that this was a deliverable study. The manuscript sets out how we established a prospective national study to evaluate all new breast localisation devices, comparing these to the historical standard of wire localisation. The simple aims of the study were to provide patients, clinicians and manufacturers with robustly-audited outcomes for these localisation devices, and to provide a platform for shared learning on device usage, with oversight of this evaluation from a body of professionals committed to the safe introduction of surgical devices.
The iBRA-NET Localisation Study has succeeded due to the dedication of surgeons involved, who recognise the need for better evaluation, and who want to better inform their patients of the surgical devices they use. This type of data collection is time-consuming, but, if we come together as a collaborative group, these vital data can be gathered more efficiently. This manuscript compares the outcomes of wire localisation and Magseed localisation for impalpable breast cancer, but two further arms of this platform study are already ongoing, to evaluate two new breast lesion localisation devices. This study is a demonstration that there is a better way to evaluate devices, than the historical isolated case-series.
Manufacturers and their representatives have often borne the brunt of clinician frustration when unable to provide evidence on their product’s efficacy. However, manufacturers clearly recognise the benefits of good evaluation. This study begins to demonstrate that when clinicians and manufacturers work toward a common goal, adoption can be more efficient and safer. From a manufacturer’s viewpoint, they understand that demonstration of efficacy drives sales; they also understand that clinicians are more likely to use the device if it is part of an approved and governed study. Collaborative research has its limitations, but thanks to the hard work of many, we can demonstrate product efficacy in a short period of time.
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