Around the world tremendous efforts have been made to improve patient care and outcomes, such as innovative devices, more reproducible surgical techniques, increased adoption of technology and through personalisation to the individual patients.
In order to assess the impact and performance of such developments it is necessary to consider ways in which such improvements can be measured. Assessments such as wear simulators and artificial intelligence modelling are useful during the conception and design phases in device development, however these are no match compared to the actual physical analysis of an explanted medical device from real patients in the general setting.
The challenge of facilitating swift and efficient access to this feedback has seen the genesis of the NHS Implant Analysis Service – an independent mechanism which, for the first time, has facilitated and enabled the key benefits of physical analysis whilst addressing the major challenges which have prevented such a service from coming to fruition in the past.
The primary goal of the NHS Implant Analysis Service is improved patient safety through independent analysis, however the service offers wider benefits to all parties including manufacturers by ensuring the availability of the devices.
The UK has an enviable record when it comes to data collection, primarily through the National Joint Registry which gathers key data following surgery. Crucially, the physical analysis of used medical devices does not form part of this data. This appears to be the same for all the other joint registries across the world, including the oldest established NJR in
Sweden. Put simply, these bodies capture what has failed and how it has failed, but (primarily for logistical reasons) omit why it has failed. The ‘why’ is crucial to complete the picture and whilst some devices may be analysed through manufacturers or researchers, there is no consistent independent physical analysis.
The lack of physical analysis may mainly be due to several principal reasons :-
- A lack of a reliable means of handling the logistics
- A culture of disposal of devices in the theatre waste
- Manufacturers providing their own analysis internally when they are able to access them
- The availability of consistent independent analysis and reporting
Surgeons have until recently had a very limited number of options open to them for any analysis. One option is to send for analysis as part of a research project, however the goal of a research project may not necessarily be the performance of a particular device or the care of the individual patient. As such, the analysis is conducted within what may be fairly narrow terms of reference, relying on very large volumes of data and taking extensive time.
Some UMDs can be returned to the manufacturer for analysis. This raises an obvious question around the lack of an independent analysis and a subtler question around logistics of patient consent, product decontamination, and different techniques employed by different
manufacturers makes direct comparisons difficult.
There is no clear established route for such analysis to be facilitated; it varies from one company to the next, and the process for sending the UMD in a compliant, timely manner throws up further challenges. Of course, all manufacturers need to carry out post-market surveillance on their products, however this is incredibly difficult when a majority of these
explanted products are thrown away.
The NHS Implant Analysis Service offers an opportunity for consistency of reporting across the manufacturers. Where product issues require further scrutiny the manufacturer would be able to conduct its own analysis where it is required. The NHS Implant Analysis Service generally aims to have conducted full analysis from 2 days to 2 weeks, so no major delays
are anticipated with access to the devices.
The NHS Implant Analysis Service is wholly independent as it is in receipt of no funding from academic institutions or manufacturers. The physical analysis conducted by this new national service is impartial, objective and travels between the service and the surgeon requesting it in a linear movement.
Whilst the service is called the NHS Implant Analysis Service there is scope for private hospitals and manufacturers to utilise the service directly which may in particular assist private hospitals, insurers and original manufacturers.
Barriers and Solutions
There are a number of barriers that have, to date, prevented the creation of a streamlined national service for implant analysis, including the risk of real or perceived bias outlined above. So prohibitive were the barriers, most surgeons resorted to throwing their UMDs in the bin in the vast majority of cases.
Consent is a major issue in the handling of any device. When a device is implanted, it becomes part of the patient’s body and as such cannot be said to be “owned” by anyone other than the patient. When the device is explanted, since the NHS purchased the device as a product from a manufacturer, the manufacturer cannot still own the device. The manufacturer however is duty bound to conduct post market surveillance and where hospitals take a decision to throw it the bin, the manufacturer would have no claim on it.
The NHS Implant Analysis Service operates with explicit patient consent – patients are informed and asked for consent to have their device analysed when consenting to the revision surgery.
In order to undertake physical analysis and report on the outcome, there is a requirement for some basic patient data (age, weight, etc.). This introduces the element of data protection and information governance, which throws up a varied set of challenges. The NHS Implant Analysis Service has therefore undertaken a fully compliant Data Protection Impact Analysis, with robust measures in place to limit the patient data gathered and protecting the usage of, and access to, that data. The lab does not receive any patient identifiable data.
The fundamental goal of the service is patient safety. The success or failure of any medical device is a complex and multifaceted picture to obtain but the fuller the picture, the more opportunity there is to learn from every single explanted device. The physical analysis of the device, despite being a crucial part of that picture, has been missing for too long. Access to an impartial, detailed breakdown of what has actually happened to the device once implanted provides benefits for manufacturers and surgeons alike, but both of these lead to improved
outcomes for patients, be it through more informed and discerning surgeons or the production of new, improved devices by manufacturers with the benefit of a wide-ranging, impartial dataset. The long-term result is more effective devices being implanted, leading to fewer failures and therefore fewer procedures.
That is not to detract from the other key benefit of the Implant Analysis Service – speed. A surgeon sending their UMD to the service can expect to receive an analysis report within days, something unique to this new service. The report arrives in time for use by the surgeon in MDT meetings, and most importantly being able to disclose those findings to the patient, closing that communication gap early and leaving the patient more informed and reassured. The benefits extend further to the hospital – fewer procedures, higher patient satisfaction, better value for money, improved choice of implants for different patient cohorts and more information for better decision making and handling of issue if they emerge.
The NHS Implant Analysis Service, with its unique blend of independence, impartiality and efficiency, is therefore a welcome intervention in an industry that has long acknowledged a gap in the learning around the performance of devices in the general setting. The service enjoys the support of patient representative groups, surgeons, and regulatory bodies such as the MHRA, ODEP, Beyond Compliance, the NJR and NICE whose leadership have supported the development of the service. Furthermore, manufacturers in the main have been very keen
on this service as it ensures less devices end up in the clinical waste and it assists with post market surveillance.
In summary, there is now an option to have devices analysed as a matter of course to learn, develop better understanding of devices and surgical techniques and ensure better outcomes and improved patient safety.
Authors: Team at NHS Implant Analysis Service, principle author Jason Wilson
For more information, visit: https://www.implantanalysis.nth.nhs.uk/