Application of Pulsating Vacuum Cleaning Technology to Medical Devices Cleaning

This study aims to solve existing problems in cleaning medical devices, such as the cumbersome loading of minimally invasive surgical instruments, the incomplete cleaning of instruments with complex structures, and the low cleaning efficiency of ordinary instruments. A pulsating vacuum cleaning machine was combined with ultrasonic cleaning and boiling cleaning technology to clean various complex medical devices through a pressure pulsating process (i.e., repetitive pump-out and pumpin until the cleaning results meet the cleaning standards for medical devices). The cleaning results of spay washing, ultrasound cleaning and pulsating vacuum cleaning were compared among four groups of medical devices, including silica gel hoses, chamber instruments, whole box of minimally invasive instruments and surgical instruments. The amount of protein residues was tested using the spectrophotometric method. The testing results revealed that the loading capacity of a pulsating vacuum cleaning machine is 3–4 times as much as that of an ordinary spray cleaning machine, without manual placement and connection operation required, which reduced the workload of pretreatment. The protein residue after cleaning meets the requirements of the YY/T0734 standard for the cleaning effect of medical devices. Pulsating vacuum cleaning technology has an overall better loading capacity, when compared to spay washing and ultrasound cleaning, and this can make up for the shortcomings of commonly used cleaning machines, such as the low cleaning efficiency and unsatisfactory cleaning results of medical devices with complex structures.

Preclinical Validation of a Novel Injection-Molded Swab for the Molecular Assay Detection of SARS-CoV-2

During the COVID-19 public health emergency, many actions have been undertaken to help ensure that patients and health care providers have timely and continued access to high-quality medical devices to respond effectively. The development and validation of new testing supplies and equipment, including collection swabs, has helped to expand the availability and capability for various diagnostic, therapeutic, and protective medical devices in high demand during the COVID-19 emergency. Here, we report the initial validation of a new injection-molded anterior nasal swab, ClearTip™, that was experimentally validated in a laboratory setting as well as in independent clinical studies in comparison to gold standard flocked swabs. We have also developed an in vitro anterior nasal tissue model which offers a novel, efficient, and clinically relevant validation tool to replicate the clinical swabbing workflow with high fidelity, while being accessible, safe, reproducible, and time- and cost-effective. ClearTip™ displayed greater inactivated virus release in the benchtop model, confirmed by its greater ability to report positive samples in a small clinical study in comparison to flocked swabs. We also quantified the detection of biological materials, as a proxy for viral material, in multi-center pre-clinical and clinical studies which showed a statistically significant difference in one study and a reduction in performance in comparison to flocked swabs. Taken together, these results emphasize the compelling benefits of non-absorbent injection-molded anterior nasal swabs for COVID-19 detection, comparable to standard flocked swabs. Injection-molded swabs, as ClearTip™, could have the potential to support future swab shortages, due to its manufacturing advantages, while offering benefits in comparison to highly absorbent swabs in terms of comfort, limited volume collection, and potential multiple usage.

KAZAKHSTAN'S MARKET POSITIONS WITHIN THE EAEU

В данной статье рассмотрена проблема реализации процесса регистрации медицинских изделий в рамках ЕАЭС. Проанализирован рынок аккредитованных лаборатории, способных проводить испытания для дальнейшего процесса регистрации. А также стоит обратить внимание на нехватку лабораторий, способных проводить различные испытания на безопасность медицинских изделий в Казахстане в рамках ЕАЭС. This article discusses the problem of implementing the registration process of medical devices within the EAEU. The market of accredited laboratories capable of conducting tests for the further registration process is analyzed. And it is also worth paying attention to the shortage of laboratories capable of conducting various tests for the safety of medical devices in Kazakhstan within the framework of the EAEU.

Use of Nanotechnology to Mitigate Biofouling in Stainless Steel Devices Used in Food Processing, Healthcare, and Marine Environments

In humid environments, the formation of biofilms and microfouling are known to be the detrimental processes that first occur on stainless steel surfaces. This is known as biofouling. Subsequently, the conditions created by metabolites and the activity of organisms trigger corrosion of the metal and accelerate corrosion locally, causing a deterioration in, and alterations to, the performance of devices made of stainless steel. The microorganisms which thus affect stainless steel are mainly algae and bacteria. Within the macroorganisms that then damage the steel, mollusks and crustaceans are the most commonly observed. The aim of this review was to identify the mechanisms involved in biofouling on stainless steel and to evaluate the research done on preventing or mitigating this problem using nanotechnology in humid environments in three areas of human activity: food manufacturing, the implantation of medical devices, and infrastructure in marine settings. Of these protective processes that modify the steel surfaces, three approaches were examined: the use of inorganic nanoparticles; the use of polymeric coatings; and, finally, the generation of nanotextures.

White paper on Promoting Domestic Manufacturing of Medical Devices

India’s medical device market is the fourth largest in India and one of the top 20 worldwide; however import dependence to the tunes of about 80 percent of overall sales is an impediment to achieve self-reliance vis-a-vis domestic manufacturing of medical devices and equipments. This high reliance on imports presents a grand opportunity to domestic manufacturers. An enabled ecosystem that promotes indigenous manufacturing of medical devices is crucial for the growth of the health care sector. The current white paper analyses various scenarios for manufacturing capability of different medical technologies and probable recommendations to augment and strengthen production within each scenario.The four scenarios described in the paper includes (1) those medical devices for which there is a high domestic demand that is fulfilled through imports even if domestic manufacturing capacity exists, implying low production in the country (2) relatively low-end technology medical devices for which there is domestic demand with high reliance on imports (3) high-end technology devices which are imported to satisfy domestic need and for which there is no domestic manufacturing capacity (4) medical devices which are being exported to rest of the World. The paper recommends for a comprehensive regulatory overhauls, review of existing taxation structure, calibrated customs duty, fixed term capital subsidy, extended coverage of PLI scheme, strengthening the research and innovation ecosystem, emphasis on technology transfer and building brand India as some of the measures that can potentially favour promotion of domestic manufacturing of medical devices and allow the India Med-Tech sector to grow into global champions.

A Review on Damage and Rupture Modelling for Soft Tissues

Computational modelling of damage and rupture of non-connective and connective soft tissues due to pathological and supra-physiological mechanisms is vital in the fundamental understanding of failures. Recent advancements in soft tissue damage models play an essential role in developing artificial tissues, medical devices/implants, and surgical intervention practices. The current article reviews the recently developed damage models and rupture models that considered the microstructure of the tissues. Earlier review works presented damage and rupture separately, wherein this work reviews both damage and rupture in soft tissues. Wherein the present article provides a detailed review of various models on the damage evolution and tear in soft tissues focusing on key conceptual ideas, advantages, limitations, and challenges. Some key challenges of damage and rupture models are outlined in the article, which helps extend the present damage and rupture models to various soft tissues.

Robotic Systems in Radiotherapy and Radiosurgery

Purpose of Review This review provides an overview of robotic systems in radiotherapy and radiosurgery, with a focus on medical devices and recently proposed research systems. We summarize the key motivation for using robotic systems and illustrate the potential advantages. Recent Findings. Robotic systems have been proposed for a variety of tasks in radiotherapy, including the positioning of beam source, patients, and imaging devices. A number of systems are cleared for use in patients, and some are widely used, particularly for beam and patient positioning. Summary The need for precise and safe delivery of focused high doses to the target region motivates the use of robots in radiotherapy. Flexibility in the arrangement of beams and the ability to compensate for target motion are key advantages of robotic systems. While robotic patient couches are widely used and robotic beam positioning is well established, brachytherapy robots are mostly considered in a research context.

Learning from the report of the independent medicines and medical devices safety review: “first do no harm”

This is a review of the learning points from the Independent Medicines and Medical Devices Safety Review, 1 chaired by Baroness Julia Cumberlege CBE DL. This system-wide review was initiated by the then Secretary of State for Health and Social Care, following patient-led campaigns. It looked at how the “healthcare system reacted as a whole, and how that response can be made more robust, speedy and appropriate”. We aim to highlight the learning points for doctors in Obstetrics and Gynaecology as these are relevant to our current practice and future changes in our healthcare system. These are: Aims of the review: why it was initiated and how it was conducted Overarching themes and missed opportunities to prevent avoidable harm Three clinical scenarios: their histories, issues and adverse events associated with their use and the current response in Scotland The hormone pregnancy test - Primodos The anti-epileptic drug - sodium valproate Surgical mesh for prolapse & incontinence The recommendations made by the review and implementation guidance Responses to the review, such as apologies issued by BSUG 2 /BAUS 3 /RCOG, 4 and compensations schemes such as the Scottish scheme as recommended by the review