There is a disparity between low and middle-income countries (LMICs) and high-income countries (HICs) in translating medical device innovations to the market, affecting health care service delivery. ...Whereas medical technologies developed in HICs face substantial challenges in getting to the bedside, there are at least clear pathways in most of the major markets, such as the UK, the EU, and the USA. Much less is known about the challenges that innovators of medical technologies face in LMICs. The aim of this study was to map out current bottlenecks in medical device innovation in Uganda, a LMIC in Sub-Saharan East Africa.
The European Union Medical Device Regulations 2017/745 entered into force on May 2021 with changes related to strengthening the clinical evaluation requirements, particularly for high-risk devices. ...This study investigates how the increased requirements on medical device manufacturers in relation to how clinical evaluation will challenge manufacturers. A quantitative survey study was utilized with responses from 68 senior or functional area subject matter experts working in medical device manufacturing Regulatory or Quality roles. The findings from the study demonstrated that the highest source of reactive Post-Market Surveillance data was customer complaints and proactive data were Post-Market Clinical Follow-Up. In contrast, the top 3 sources for generating clinical evaluation data for legacy devices under the new Medical Device Regulations were Post-Market Surveillance data, Scientific literature reviews, and Post-Market Clinical Follow-Up studies. Manufacturers’ biggest challenge under the new Medical Device Regulations is determining the amount of data needed to generate sufficient clinical evidence, while over 60% of high-risk device manufacturers have outsourced the writing of their clinical evaluation reports. Manufacturers also reported a high investment in clinical evaluation training and highlighted inconsistencies in the requirements for clinical data by different notified bodies. These challenges may lead to a potential shortage of certain medical devices in the E.U. and a delay in access to new devices, negatively impacting patient quality of life (1). This study provides a unique insight into the challenges currently experienced by medical device manufacturers as they transition to the MDR clinical evaluation requirements and the subsequent impact on the continued availability of medical devices in the E.U.
A significant amount of European basic and clinical neuroscience research includes the use of transcranial magnetic stimulation (TMS) and low intensity transcranial electrical stimulation (tES), ...mainly transcranial direct current stimulation (tDCS). Two recent changes in the EU regulations, the introduction of the Medical Device Regulation (MDR) (2017/745) and the Annex XVI have caused significant problems and confusions in the brain stimulation field. The negative consequences of the MDR for non-invasive brain stimulation (NIBS) have been largely overlooked and until today, have not been consequently addressed by National Competent Authorities, local ethical committees, politicians and by the scientific communities. In addition, a rushed bureaucratic decision led to seemingly wrong classification of NIBS products without an intended medical purpose into the same risk group III as invasive stimulators.
Overregulation is detrimental for any research and for future developments, therefore researchers, clinicians, industry, patient representatives and an ethicist were invited to contribute to this document with the aim of starting a constructive dialogue and enacting positive changes in the regulatory environment.
In recent years, the use of Artificial Intelligence (AI) in the medical field has attracted increased attention. Due to their impressive advantages, AI systems offer excellent prospects for medical ...device manufacturers using these systems to upgrade their products. Such AI-based medical devices are already subject to partial regulation within the lines of Medical device regulation 745/2017. However, following the proposal for a regulation on artificial intelligence published by the European Commission, the regulatory landscape for these devices has partially changed. This article aims to clarify the influences that this regulatory intervention by the European Commission brings to the path towards the use and marketing of AI-based medical devices.
Modern surgical departments are characterized by a high degree of automation supporting complex procedures. It recently became apparent that integrated operating rooms can improve the quality of ...care, simplify clinical workflows, and mitigate equipment-related incidents and human errors. Particularly using computer assistance based on data from integrated surgical devices is a promising opportunity. However, the lack of manufacturer-independent interoperability often prevents the deployment of collaborative assistive systems. The German flagship project OR.NET has therefore developed, implemented, validated, and standardized concepts for open medical device interoperability. This paper describes the universal OR.NET interoperability concept enabling a safe and dynamic manufacturer-independent interconnection of point-of-care (PoC) medical devices in the operating room and the whole clinic. It is based on a protocol specifically addressing the requirements of device-to-device communication, yet also provides solutions for connecting the clinical information technology (IT) infrastructure. We present the concept of a service-oriented medical device architecture (SOMDA) as well as an introduction to the technical specification implementing the SOMDA paradigm, currently being standardized within the IEEE 11073 service-oriented device connectivity (SDC) series. In addition, the Session concept is introduced as a key enabler for safe device interconnection in highly dynamic ensembles of networked medical devices; and finally, some security aspects of a SOMDA are discussed.
Peripherally inserted central catheters (PICC-lines) used in neonatology are made of thermoplastic polyurethane (TPU) or silicone. These materials usually contain substances that may leach into drug ...vehicles or blood. In this extractables study, we determined the optimal extraction conditions using TPU films containing defined amounts of butylhydroxytoluene (BHT) and then applied them on unused and explanted PICC-lines. Maceration and sonication tests were carried out with hexane, acetone and water as the extraction solvents. The analyses were performed using gas and liquid chromatography coupled with mass spectrometry detectors, as well as inductive coupled plasma optical emission spectroscopy to detect a wide range of extractables. We selected a limited list of substances to be sought from the usual adjuvants and monomers, related to their carcinogenic, mutagenic or reprotoxic properties and/or existence in endocrine disruptors lists. The TPU-film experiments showed that acetone was slightly better than hexane, and maceration better than sonication. When applied to PICC-lines, the extraction methods were almost similar but acetone was clearly better than hexane for TPU. From the 48 peaks initially observed in GC-MS, we ended up with 37 peaks to follow in TPU PICC-lines, among which were those of BHT and 4,4′-Methylenebis(cyclohexyl isocyanate) isomers. For silicone PICC-lines, out of 41 peaks initially observed in GC-MS, we followed 20 peaks, most of them being identified as cyclosiloxanes. Barium was the main inorganic element extracted for both PICC-lines. For TPU PICC-lines, the inter-batch variability was higher than for intra-batch, but in silicone devices both were similar. When compared to new PICC-lines, explanted TPU PICC-lines extracted peaks had a lower area under the curve (AUC), while the AUCs of the peaks were higher for the majority of silicone PICC-lines extract compounds. No identified substances were detected above their toxicological threshold, but isocyanates and cyclosiloxanes toxicity was mostly studied for other exposition routes than intravenous. The methods defined in this study were efficient in producing extractable profiles from both PICC-lines.
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•Method allowed extractables and leachables study from PICC-lines.•Maceration in acetone produced the most extractables, especially for TPU PICC-lines.•At least 48 (TPU PICC-lines) and 41 (silicone PICC-lines) substances were extracted.•The main extractables observed from both PICC-lines were monomers and oligomers.•PICC-line implantation significantly impacted the extractables profile.
IMPORTANCE: Most regulated medical devices enter the US market via the 510(k) regulatory submission pathway, wherein manufacturers demonstrate that applicant devices are “substantially equivalent” to ...1 or more “predicate” devices (legally marketed medical devices with similar intended use). Most recalled medical devices are 510(k) devices. OBJECTIVE: To examine the association between characteristics of predicate medical devices and recall probability for 510(k) devices. DESIGN, SETTING, AND PARTICIPANTS: In this exploratory cross-sectional analysis of medical devices cleared by the US Food and Drug Administration (FDA) between 2003 and 2018 via the 510(k) regulatory submission pathway, linear probability models were used to examine associations between a 510(k) device’s recall status and characteristics of its predicate medical devices. Public documents for the 510(k) medical devices were collected using FDA databases. A text extraction algorithm was applied to identify predicate medical devices cited in 510(k) regulatory submissions. Algorithm-derived metadata were combined with 2003-2020 FDA recall data. EXPOSURES: Citation of predicate medical devices with certain characteristics in 510(k) regulatory submissions, including the total number of predicate medical devices cited by the applicant device, the age of the predicate medical devices, the lack of similarity of the predicate medical devices to the applicant device, and the recall status of the predicate medical devices. MAIN OUTCOMES AND MEASURES: Class I or class II recall of a 510(k) medical device between its FDA regulatory clearance date and December 31, 2020. RESULTS: The sample included 35 176 medical devices, of which 4007 (11.4%) were recalled. The applicant devices cited a mean of 2.6 predicate medical devices, with mean ages of 3.6 years and 7.4 years for the newest and oldest, respectively, predicate medical devices. Of the applicant devices, 93.9% cited predicate medical devices with no ongoing recalls, 4.3% cited predicate medical devices with 1 ongoing class I or class II recall, 1.0% cited predicate medical devices with 2 ongoing recalls, and 0.8% cited predicate medical devices with 3 or more ongoing recalls. Applicant devices citing predicate medical devices with 3 or more ongoing recalls were significantly associated with a 9.31–percentage-point increase (95% CI, 2.84-15.77 percentage points) in recall probability compared with devices without ongoing recalls of predicate medical devices, or an 81.2% increase in recall probability relative to the mean recall probability. A 1-SD increase in the total number of predicate medical devices cited by the applicant device was significantly associated with a 1.25–percentage-point increase (95% CI, 0.62-1.87 percentage points) in recall probability, or an 11.0% increase in recall probability relative to the mean recall probability. A 1-SD increase in the newest age of a predicate medical device was significantly associated with a 0.78–percentage-point decrease (95% CI, 1.29-0.30 percentage points) in recall probability, or a 6.8% decrease in recall probability relative to the mean recall probability. CONCLUSIONS AND RELEVANCE: This exploratory cross-sectional study of 510(k) medical devices cleared by the FDA between 2003 and 2018 demonstrated significant associations between 510(k) submission characteristics and recalls of medical devices. Further research is needed to understand the implications of these associations.
IMPORTANCE: In the US, nearly all medical devices progress to market under the 510(k) pathway, which uses previously authorized devices (predicates) to support new authorizations. Current regulations ...permit manufacturers to use devices subject to a Class I recall—the FDA’s most serious designation indicating a high probability of adverse health consequences or death—as predicates for new devices. The consequences for patient safety are not known. OBJECTIVE: To determine the risk of a future Class I recall associated with using a recalled device as a predicate device in the 510(k) pathway. DESIGN AND SETTING: In this cross-sectional study, all 510(k) devices subject to Class I recalls from January 2017 through December 2021 (index devices) were identified from the FDA’s annual recall listings. Information about predicate devices was extracted from the Devices@FDA database. Devices authorized using index devices as predicates (descendants) were identified using a regulatory intelligence platform. A matched cohort of predicates was constructed to assess the future recall risk from using a predicate device with a Class I recall. MAIN OUTCOMES AND MEASURES: Devices were characterized by their regulatory history and recall history. Risk ratios (RRs) were calculated to compare the risk of future Class I recalls between devices descended from predicates with matched controls. RESULTS: Of 156 index devices subject to Class I recall from 2017 through 2021, 44 (28.2%) had prior Class I recalls. Predicates were identified for 127 index devices, with 56 (44.1%) using predicates with a Class I recall. One hundred four index devices were also used as predicates to support the authorization of 265 descendant devices, with 50 index devices (48.1%) authorizing a descendant with a Class I recall. Compared with matched controls, devices authorized using predicates with Class I recalls had a higher risk of subsequent Class I recall (6.40 95% CI, 3.59-11.40; P<.001). CONCLUSIONS AND RELEVANCE: Many 510(k) devices subjected to Class I recalls in the US use predicates with a known history of Class I recalls. These devices have substantially higher risk of a subsequent Class I recall. Safeguards for the 510(k) pathway are needed to prevent problematic predicate selection and ensure patient safety.
Automation with inherent artificial intelligence (AI) is increasingly emerging in diverse applications, for instance, autonomous vehicles and medical assistance devices. However, despite their ...growing use, there is still noticeable skepticism in society regarding these applications. Drawing an analogy from human social interaction, the concept of trust provides a valid foundation for describing the relationship between humans and automation. Accordingly, this paper explores how firms systematically foster trust regarding applied AI. Based on empirical analysis using nine case studies in the transportation and medical technology industries, our study illustrates the dichotomous constitution of trust in applied AI. Concretely, we emphasize the symbiosis of trust in the technology as well as in the innovating firm and its communication about the technology. In doing so, we provide tangible approaches to increase trust in the technology and illustrate the necessity of a democratic development process for applied AI.
•We examine how is trust in autonomous vehicles and medical assistance devices fostered.•We illustrate the dichotomous constitution of trust in applied artificial intelligence.•First, trust in the technology is important.•Besides, trust in the innovating firm and its communication is decisive.
Contact lenses are US Food and Drug Administration-regulated medical devices that are a safe and effective method for the correction of refractive error. They are worn by an estimated 45 million ...Americans. Decorative contact lenses (DCLs) can be used for patients with medical conditions such as failed corneas or aniridia. However, DCLs have also gained popularity in the young, contact lens-naïve population. DCL users often buy lenses through unregulated sources without a clinical examination and education on proper use by an eye care professional. These lenses have a significantly higher risk of infection when compared with contact lenses for the correction of refractive error. To reduce the incidence of microbial keratitis, regulators and eye care professionals must make coordinated efforts to generate and disseminate prevention messages to all contact lens users. In addition, physician and patient reporting of contact lens-related complications to regulatory agencies enhances the pathway to risk reduction. This article reviews DCL use and supply, with a specific focus on the increased risk of contact lens-related complications in unsupervised DCL use.
