The implementation of artificial intelligence (AI) applications in routine practice, following regulatory approval, is currently limited by practical concerns around reliability, accountability, trust, safety, and governance, in addition to factors such as cost-effectiveness and institutional information technology support. When a technology is new and relatively untested in a field, professional confidence is lacking and there is a sense of the need to go above the baseline level of validation and compliance. In this article, we propose an approach that goes beyond standard regulatory compliance for AI apps that are approved for marketing, including independent benchmarking in the lab as well as clinical audit in practice, with the aims of increasing trust and preventing harm.

Regulatory and other governance arrangements influence the introduction of medical devices into health systems and are essential for ensuring their effective and safe use. Challenges with medical device safety, quality and use are documented globally, with evidence suggesting these are linked to poor governance. Yet, medical device regulation and oversight remain inadequately defined and described, particularly in low-income and middle-income settings. Through this review, we sought to examine the literature available on regulatory and oversight processes for medical devices in African countries.Following a systematic approach, we searched academic databases including PubMed, Embase (Ovid) and MEDLINE (Ovid), supplemented by search for grey literature and relevant organisational websites, for documents describing medical device regulation and oversight in African countries. We summarised the data to present key actors, areas for regulation and oversight and challenges.A total of 39 documents reporting regulation and oversight of medical devices were included for analysis. Regulatory and oversight guidelines and processes were reported as inadequate, including limited pre-market testing, reliance on international certifications and limited processes for post-market monitoring and reporting of adverse events. Challenges for regulation and oversight reported included inadequate funding, personnel and technical expertise to perform regulatory functions. The literature highlighted gaps in guidelines for donated medical devices and in information on governance processes at the national level.The current literature provides a general overview of medical device regulatory guidelines and limited evidence on the implementation of regulatory/oversight processes at national and especially subnational levels. We recommend further research to elucidate existing governance arrangements for medical devices within African countries and propose a conceptual framework to inform future studies. The framework provides entry points for careful examination of governance and oversight in policy and practice, the exploration of governance realities across the health system and the influence of wider system dynamics.

Recently introduced total knee arthroplasty (TKA) implants have been linked with the early development of periprosthetic radiolucency (PPRL). The aim of this study was to carry out a retrospective clinical and radiographical analysis of a consecutive series of a new TKA, and to assess the incidence and distribution of PPRL.

A retrospective review of all new TKA implants performed by a single surgeon at a single hospital between March 2013 and October 2017 was performed. The minimum follow-up period was 3 months, with ongoing patient review at 6, 12 and 36 months. Sequential post-operative radiographs were performed to determine the presence of PPRL.

A total of 122 TKAs were identified in 112 patients over the 4.5-year study period. The average follow-up time was 21 months (range 3-51 months). PPRL was noted in 29 TKAs (23.8%). When comparing the PPRL group to those without PPRL, there was a difference in body mass index, with body mass index associated with an increased likelihood of PPRL (P = 0.003). There was no difference in constraint of implant (P = 0.818), cement type (P = 0.340), patella resurfacing (P = 0.286), age (P = 0.984) gender (P = 0.376) or initial mechanical axis deviation (P = 0.054) between groups. PPRL were most commonly seen in tibial anterior-posterior (AP) zone 1 and zone 2 (96.6%), followed by femoral lateral zone 5 (58.6%), tibia lateral zone 1 (55.2%) and tibial lateral zone 2 (53.2%). No patients have required revision surgery.

A high incidence of early PPRL is seen in patients undergoing primary TKA using a new implant system, mainly involving the tibial component. Ongoing clinical and radiological assessment for patients seems warranted based on these findings.

Total knee arthroplasty (TKA) is an established and successful procedure. However, the design of prostheses continues to be modified in an attempt to optimise the functional outcome of the patient. The aim of this study was to determine if patient outcome after TKA was influenced by the design of the prosthesis used. A total of 212 patients (mean age 69; 43 to 92; 131 female (62%), 81 male (32%)) were enrolled in a single centre double-blind trial and randomised to receive either a Kinemax (group 1) or a Triathlon (group 2) TKA. Patients were assessed pre-operatively, at six weeks, six months, one year and three years after surgery. The outcome assessments used were the Oxford Knee Score; range of movement; pain numerical rating scales; lower limb power output; timed functional assessment battery and a satisfaction survey. Data were assessed incorporating change over all assessment time points, using repeated measures analysis of variance longitudinal mixed models. Implant group 2 showed a significantly greater range of movement (p = 0.009), greater lower limb power output (p = 0.026) and reduced report of 'worst daily pain' (p = 0.003) over the three years of follow-up. Differences in Oxford Knee Score (p = 0.09), report of 'average daily pain' (p = 0.57) and timed functional performance tasks (p = 0.23) did not reach statistical significance. Satisfaction with outcome was significantly better in group 2 (p = 0.001). These results suggest that patient outcome after TKA can be influenced by the prosthesis used.

In the United Kingdom, there are more than 9000 reports of adverse events involving medical devices annually. The regulatory processes in Europe and in the United States have been challenged as to their ability to protect patients effectively from unreasonable risk and harm. Two of the major shortcomings of current practice include the lack of transparency in the safety certification process and the lack of involvement of service providers. We reviewed recent international standardisation activities in this area, and we reviewed regulatory practices in other safety-critical industries. The review showed that the use of safety cases is an accepted practice in UK safety-critical industries, but at present, there is little awareness of this concept in health care. Safety cases have the potential to provide greater transparency and confidence in safety certification and to act as a communication tool between manufacturers, service providers, regulators and patients.