The increasing prevalence of infectious diseases in recent decades has posed a serious threat to public health. Routes of transmission differ, but the respiratory droplet or airborne route has the greatest potential to disrupt social intercourse, while being amenable to prevention by the humble face mask. Different types of masks give different levels of protection to the user. The ongoing COVID-19 pandemic has even resulted in a global shortage of face masks and the raw materials that go into them, driving individuals to self-produce masks from household items. At the same time, research has been accelerated towards improving the quality and performance of face masks, e.g., by introducing properties such as antimicrobial activity and superhydrophobicity. This review will cover mask-wearing from the public health perspective, the technical details of commercial and home-made masks, and recent advances in mask engineering, disinfection, and materials and discuss the sustainability of mask-wearing and mask production into the future.

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Face Masks in the New COVID-19 Normal: Materials, Testing, and Perspectives.

The development of innovative wearable technologies has raised great interest in new means of data collection in healthcare and biopharmaceutical research and development. Multiple applications for wearables have been identified in a number of therapeutic areas; however, researchers face many challenges in the clinic, including scientific methodology as well as regulatory, legal, and operational hurdles. To facilitate further evaluation and adoption of these technologies, we highlight methodological and logistical considerations for implementation in clinical trials, including key elements of analytical and clinical validation in the specific context of use (COU). Additionally, we provide an assessment of the maturity of the field and successful examples of recent clinical experiments.

Wearable Devices in Clinical Trials: Hype and Hypothesis.

Algorithms must meet regulatory standards of clinical benefit Artificial intelligence (AI) and increased computing power have long held the promise of improving prediction and prognostication in health care (1). Now, use of predictive analytics and AI in medicine, though with fits and starts, is transitioning from hype to reality: Several commercial algorithms have received regulatory approval for broad clinical use. But the barrier for entry of new advanced algorithms has been low. To unlock the potential of advanced analytics while protecting patient safety, regulatory and professional bodies should ensure that advanced algorithms meet accepted standards of clinical benefit, just as they do for clinical therapeutics and predictive biomarkers. External validation and prospective testing of advanced algorithms are clearly needed (2), but recent regulatory clearances raise concerns over the rigor of this process. Given these concerns, we propose five standards to guide regulation of devices based on predictive analytics and AI. Although well-established research standards, such as the TRIPOD Checklist, exist for developing and validating multivariable prediction models in medicine (3), our standards provide regulatory guidance for such algorithms prior to implementation in clinical settings.

/pdf/regulation-of-predictive-analytics-in-medicine-pa0dmb87z6.pdf

Regulation of predictive analytics in medicine

Hollow microneedles: A perspective in biomedical applications.

Introduction Transvaginal mesh devices are approved in the USA by the Food and Drug Administration (FDA), through the 510(k) system. However, there is uncertainty about the benefit to harm balance of mesh approved for pelvic organ prolapse. We, therefore, assessed the evidence at the time of approval for transvaginal mesh products and the impact of safety studies the FDA mandated in 2012 because of emerging harms. Methods We used FDA databases to determine the evidence for approval of transvaginal mesh. To create a ‘family tree’ of device equivalence, we used the 510(k) regulatory approval of the 1985 Mersilene Mesh (Ethicon) and the 1996 ProteGen Sling (Boston Scientific), searched for all subsequently related device approvals, and for the first published randomised trial evidence. We assessed compliance with all FDA 522 orders issued in 2012 requiring postmarketing surveillance studies. Results We found 61 devices whose approval ultimately relied on claimed equivalence to the Mersilene Mesh and the ProteGen Sling. We found no clinical trials evidence for these 61 devices at the time of approval. Publication of randomised clinical trials occurred at a median of 5 years after device approval (range 1–14 years). Analysis of 119 FDA 522 orders revealed that in 79 (66%) the manufacturer ceased market distribution of the device, and in 26 (22%) the manufacturer had changed the indication. Only seven studies (six cohorts and new randomised controlled trial) covering 11 orders were recruiting participants (none had reported outcomes). Conclusions Transvaginal mesh products for pelvic organ prolapse have been approved on the basis of weak evidence over the last 20 years. Devices have inherited approval status from a few products. A publicly accessible registry of licensed invasive devices, with details of marketing status and linked evidence, should be created and maintained at the time of approval.

https://bmjopen.bmj.com/content/bmjopen/7/12/e017125.full.pdf

Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process

Premarket approval application is not essential but 510(k) must submit to FDA to market medical device in the U.S for human use. To conclude or to determine the device is substantially equivalent to the device which is already marketed. After getting a 510(k) clearance immediately device can be marketed by submitter. In such case where already marketed device is changed in its safety or effectiveness it might affect the manufacturer and there is essential to file a 510(k) submission by manufacturer. Manufacturer should submit 510(k) to FDA in case of modifications or changes in use, chemical composition, design, energy source etc,.510(k) submission depends upon the comparison between the already marketed device and new device in the U.S, to ascertain whether the device is safety and effectiveness.2

R. Kamaraj

Papers

510(k) Premarket Notification