Medical devices
challenges and increases risk exposure. Clinical staff must carefully document their awareness of potential device limitations, additional monitoring measures implemented, and the rationale for clinical decisions made despite known device limitations.2
This documentation
burden adds complexity to already demanding clinical workflows, and discrepancies in outcomes caused by variations in device performance can have a significant economic impact on individual institutions and healthcare systems. The financial implications of inadequate
device testing extend beyond direct healthcare costs. While randomised controlled trials (RCTs) have reigned as the gold standard in evidence- based medicine, these studies are expensive, time-intensive, and often take place under artificial treatment conditions that are not replicated in real-world clinics. As Wedlund and Kvedar note, “RCTs remain the gold-standard in medicine, but as digital models improve, we can finally address cost, diversity, and size constraints to create an even stronger standard for the future”.11 More inclusive trials could help ensure clinical data that is more representative of the whole population that could benefit from a studied intervention. In silico trials are an important potential solution that can address this issue with researchers projecting that by 2025, the UK alone will purchase approximately £654 million in drugs and at least £400 million of medical devices that used in silico methods throughout their Research & Development lifecycle.12
Risk mitigation strategies Healthcare institutions must develop comprehensive approaches to address known
device limitations while ensuring optimal patient outcomes. A systematic risk mitigation framework should include several key elements. First, enhanced monitoring protocols should be implemented for high-risk patients. This might include more frequent vital sign checks, correlation with multiple monitoring devices, or earlier arterial line placement in critical care settings. For example, when using pulse oximetry in patients with darker skin tones, protocols might specify more frequent arterial blood gas sampling.9 Second, clear documentation standards must be established. Clinical staff need to maintain comprehensive records that detail known device limitations for specific patient populations and outline any additional monitoring measures
implemented.2
This documentation should
include the rationale behind clinical decisions made in light of known device limitations, along with evidence of patient education regarding device limitations and additional monitoring requirements. Importantly, any adverse events or near-misses related to device performance must be thoroughly documented to build an evidence base for future improvements. Third, healthcare teams should implement
regular training programmes that sharpen clinicians’ ability to recognise device limitations across different patient populations. These programmes should cover alternative assessment methods when device reliability is questioned, effective communication strategies for discussing device limitations with patients, and proper documentation requirements. Regular quality improvement initiatives should be integrated into these training programmes to systematically track and address device-related disparities. Finally, institutions should establish clear escalation pathways when device performance issues are identified. This includes reporting mechanisms to both internal quality improvement teams and external regulatory bodies,2
ensuring that device performance
data across diverse populations continues to accumulate and inform future device development. Such systematic collection of real-world performance data is crucial for driving improvements in device design and testing protocols.
Emerging solutions Although risk mitigation will always be an important part in improving safety and clinical
20
www.clinicalservicesjournal.com I February 2025
zinkevych -
stock.adobe.com
T Mdlungu/
peopleimages.com -
stock.adobe.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65
