Manufacture Of Medical Products Research Articles

Improving the Wear and Corrosion Resistance of Titanium Alloy Parts via the Deposition of DLC Coatings

This article compares the properties of the diamond-like carbon (DLC) coating with those of ZrN and (Zr,Hf)N coatings deposited on the Ti-6Al-4V titanium alloy substrate. To improve substrate adhesion during the deposition of the DLC coating, preliminary etching with chromium ions was conducted, ensuring the formation of a chromium-saturated diffusion surface layer in the substrate. A Si-DLC layer followed by a pure DLC layer was then deposited. The hardness of the coatings, their surface morphology, fracture strength in the scratch test, and tribological properties and wear resistance in the pin-on-disk test in contact with Al2O3 and steel indenters were investigated. The structure of the DLC coating was studied using transmission electron microscopy, and its corrosion resistance in an environment simulating blood plasma was also investigated. In the pin-on-disk test in contact with Al2O3 and AISI 52100 indenters, the DLC-coated sample demonstrates a much lower friction coefficient and significantly better wear resistance compared to the nitride-coated and uncoated samples. Both nitride coatings—(Zr,Hf)N and ZrN—and the DLC coating slow down the corrosive dissolution of the base compared to the uncoated sample. The corrosion currents of the (Zr,Hf)N-coated samples are 37.01 nA/cm2, 20% higher than those of the ZrN-coated samples. The application of (Zr,Hf)N, ZrN, and DLC coatings on the Ti-6Al-4V alloy significantly inhibits dissolution currents (by 30–40%) and increases polarization resistance 1.5–2.0-fold compared to the uncoated alloy in 0.9% NaCl at 40 °C. Thus, the DLC coating of the described structure simultaneously provides effective wear and corrosion resistance in an environment simulating blood plasma. This coating can be considered in the manufacture of medical products (in particular, implants) from titanium alloys, including those functioning in the human body and subject to mechanical wear (e.g., knee joint endoprostheses).

Enhancing sustainability in medical product supply chains: The role of remanufacturing and government subsidies

This study explores the impact of government subsidies on the production dynamics within the medical product supply chain, particularly focusing on the remanufacturing of medical goods. Amidst the backdrop of the COVID-19 pandemic, which has underscored the critical shortages in medical supplies, our research delves into the adoption of remanufacturing practices by medical product manufacturers as a strategic response to these shortages and environmental concerns. We investigate how government subsidies influence the production volumes of original manufacturers and remanufacturers and examine the competitive interplay between newly manufactured and remanufactured medical products. Through the development of three production game models—Scenario B (manufacturers produce both new and refurbished products), Scenario N (separate production of new and refurbished products by manufacturers and remanufacturers, respectively), and Scenario C (similar to Scenario N but includes a certification fee paid by remanufacturers to original manufacturers)—we analyze the strategies that could mitigate supply deficiencies during medical crises. Our findings indicate that the certification strategy (Scenario C) not only yields the highest total production of medical products but also offers a viable solution to enhance the sustainability of the entire medical production system by alleviating supply chain disruptions. Furthermore, we discuss the managerial implications of our results, emphasizing the potential of a joint remanufacturing strategy to stabilize the supply chain and foster environmental conservation. Lastly, we highlight our study's limitations and suggest future research directions, particularly concerning the variability in product quality and the reliance on government subsidies. This research contributes to a nuanced understanding of green remanufacturing within the pharmaceutical supply chain, offering insights for manufacturers, remanufacturers, and policymakers aiming for sustainable industry practices.

METHODS OF STERILIZATION OF MEDICAL POLYMER COMPOSITES BASED ON POLYHYDROXYBUTYRATE WITH ELASTOMERIC ADDITIVE

Introduction. Polyhydroxybutyrate is a biodegradable and completely biocompatible component, and in combination with various modifying additives can be suitable for the manufacture of medical products used in surgical practice as bone implants or their parts. There implants have a number of advantages over traditional metal products, but for their integration into the body they require thorough sterilization cleaning, which in the case of poly-mer compositions has a number of limitations associated with the possible destruction of the material structure during various cleaning stages. Purpose of the study. Find optimal methods for sterilization and disinfection of materials based on polyhydroxybutyrate (PHB) and an elastomeric additive – butadiene-nitrile rubber (NBR-28). Material and methods. Two-component PHB-NBR compositions with PHB content from 30 to 90% were studied. Four methods of sterilization and disinfection were used: autoclaving, air sterilization, disinfection with chlorine solution and ethanol solution. Determined mechanical characteristics are strength and elongation of the material at break. Sterility control – by the method of washings with subsequent observation of the growth of bacteria and fungi in Sabouraud's medium and thioglycollate medium. Results. Sterilized and disinfected samples showed no microbial growth in both culture media. No change in mechanical characteristics was detected for samples subjected to solution cleaning methods. High temperature cleaning reduced the mechanical properties of samples by 20–80% depending on the sterilization mode. Conclusions. The data obtained show that for sterilization and disinfection of PCM based on the biodegradable polymer PHB, solution methods are suitable without restrictions and the autoclave sterilization method is suitable with minor restrictions, while air sterilization leads to the destruction of PCM. The work was financially supported by the Ministry of Science and Higher Education of Russian Federation (Research theme state registration number 122041300207-2).

Role of global public sector research in discovering new drugs and vaccines

Analysis of international public-sector contributions to Food and Drug Administration (FDA)-approved drugs and vaccines allows for a more thorough examination of the global biomedical innovation ecosystem by institution of origin. Using new and existing methods, we have identified 364 FDA-approved drugs and vaccines approved from 1973 to 2016 discovered in whole or in part by Public Sector Research Institutions (PSRIs) worldwide. We identified product-specific intellectual property contributions to FDA-approved small molecule and biologic drugs and vaccines from the FDA Orange Book, our peer network, published studies, and three new sources: reports of medical product manufacturers’ payments to physicians and teaching hospitals under The Sunshine Act of 2010, a paper by Kneller and 64 royalty monetization transactions by academic institutions and/or their faculty that one of us (AS) maintains. We include a total of 293 drugs discovered either wholly by a US PSRI or jointly by a U.S. and a non-U.S. PSRI. 119 FDA-approved drugs and vaccines were discovered by PSRIs outside the U.S. Of these, 71 were solely discovered outside the US, while 48 also involved intellectual property contributions by US PSRIs. In the context of the global public sector landscape, the US dominates drug discovery, accounting for two-thirds of these drugs and many of the important, innovative vaccines introduced over the past 30 years. Contributions by Canada, UK, Germany, Belgium, Japan, and others each amount to 5.4% or less of the total.

Strength and fracture mechanism of a magnesium alloy for medical applications after equal-channel angular pressing

In this paper, we study the strength and fracture mechanism of the cast magnesium alloy Mg-Zn-Ca (1.0 % Zn, 0.2 % Ca) for medical applications after equal-channel angular pressing (ECAP) in comparison with the initial condition (after homogenization annealing). Mechanical tests included tensile and torsion tests of samples with a diameter of 3 mm and impact strength tests of samples with a V-shaped stress raiser. The microrelief of all fractures was studied in a Phenom ProX G6 scanning electron microscope (SEM). The results of tensile testing of the samples showed that the strength of the alloy after ECAP increased by a factor of 1.5 –1.8, and the elongation increased by a factor 2.6. The torsional strength of the alloy increased by a factor 1.1–1.3, and the relative shear of the alloy decreased by factor a 1.3 as compared with the alloy after annealing. In contrast to static loads, the magnesium alloy Mg-Zn-Са after ECAP is poorly resisting one-time impact loads. Analysis of the results of this study allows us to conclude that the magnesium alloy Mg-Zn-Ca after ECAP is more promising for the manufacture of medical products that experience static loads during operation, as compared with the alloy after annealing.

Strength and Fracture Mechanism of an Ultrafine-Grained Austenitic Steel for Medical Applications.

In this paper, we study the corrosion-resistant austenitic steel Fe-0.02C-18Cr-8Ni for medical applications. The microstructure and mechanical properties (tensile mechanical properties, torsional strength, impact toughness, and static and cyclic crack resistance) under different types of loading of the steel are investigated. The results are compared for the two states of the steel: the initial (coarse-grained) state and the ultrafine-grained state produced by severe plastic deformation processing via equal-channel angular pressing. It is demonstrated that the ultrafine-grained steel 0.08C-18Cr-9Ni has essentially better properties and is very promising for the manufacture of medical products for various applications that experience various static and cyclic loads during operation.

Two-component feedstock based on ultra-high molecular weight polyethylene for additive manufacturing of medical products

Abstract Ultra-high molecular weight polyethylene (UHMWPE) possesses distinctive properties, but has an extremely low melt flow rate (MFR) of about zero, which makes it unsuitable for processing by standard methods for polymers. The aim of this paper was to investigate the tribological properties of two-component UHMWPE-based composites with different content of isotactic PP. The composites were fabricated by three methods: a) hot pressing of the powder mixtures; b) hot compression of granules; and c) 3D printing (FDM). It was shown that the UHMWPE-based composites obtained by extrusion compounding (hot compression of granules and 3D printing) in terms of the mechanical and tribological properties (wear resistance, the friction coefficient, Young's modulus, and yield strength) were superior to the ones manufactured by hot pressing of the powder mixtures. The most effective was the ‘UHMWPE+20% PP’ composite in terms of maintaining high tribological and mechanical properties and the necessary melt flow rate (MFR) in a wide range of loads. It was recommended as a feedstock for additive manufacturing of complex-shaped products (joint components) for friction units in orthopedics.

How to Get Away with Immunity: FDA's Emergency Use Authorization Scheme and PREP Act Liability Protection in the Context of COVID-19

The U.S. Food and Drug Administration (FDA) plays a vital role in our country’s response to biological agents that threaten public health and safety. On December 31, 2019, officials in Wuhan, China confirmed dozens of cases of pneumonia caused by an unknown pathogen. Chinese officials later identified that pathogen as severe acute respiratory syndrome coronavirus (SARS-CoV-2), which causes the disease COVID-19. The COVID-19 pandemic has created a perfect storm for unprecedented and litigation-provoking health harms in the United States. As the country’s death toll rises and states seek to reopen, many Americans are assessing their COVID-19-related health status based on the results of diagnostic and antibody tests, which have been cleared through the FDA’s emergency use authorization scheme notwithstanding their concerning inaccuracy rates. This paper argues that the unacceptably high inaccuracy rates of these COVID-19 tests are a direct result of lax FDA regulation and oversight under current federal law. The Public Readiness and Emergency Preparedness Act of 2005 (PREP Act) established a framework that extends blanket immunity from liability to the manufacturers of medical products, including blood assays and serology tests, that are used to diagnose and treat COVID-19. The breadth and scope of the statute’s immunity make it nearly impossible for an injured plaintiff to recover from injuries sustained from their use of or reliance on diagnostic tests. This paper details and critiques PREP Act immunity and proposes several PREP Act reforms aimed at enhancing public health and safety during a infectious disease pandemic. As special interest groups ramp pressure of the federal and state legislatures to enact additional immunity protection as the states reopen, the quality of COVID-19 related care and treatment is likely to continue to worsen unless and until the country implements reforms that authorize meaningful medical device regulation and oversight.

Cost-efficient, true silicone printer with variable material spectrum for individualized medical applications

Due to their beneficial material properties, silicones have become increasingly important in the healthcare sector. However, common manufacturing techniques like injection molding are limited. Hence, silicones have become more interesting for additive manufacturing, as it is possible to freely shape individualized products in small quantities. We present a syringe printer architecture for personalized manufacturing of medical products that allows a variable mixing ratio for RTV-2 crosslinking silicones and precise dosing. Compared to other printing methods, various commercially available one or two-component silicones with variable part viscosities can be printed in a broad range from 10-3Pas up to 10³ Pas.

A Novel Convolutional Neural Network Based Model for Recognition and Classification of Apple Leaf Diseases

Plants have a great role to play in biodiversity sustenance. These natural products not only push their demand for agricultural productivity, but also for the manufacturing of medical products, cosmetics and many more. Apple is one of the fruits that is known for its excellent nutritional properties and is therefore recommended for daily intake. However, due to various diseases in apple plants, farmers have to suffer from a huge loss. This not only causes severe effects on fruit’s health, but also decreases its overall productivity, quantity, and quality. A novel convolutional neural network (CNN) based model for recognition and classification of apple leaf diseases is proposed in this paper. The proposed model applies contrast stretching based pre-processing technique and fuzzy c-means (FCM) clustering algorithm for the identification of plant diseases. These techniques help to improve the accuracy of CNN model even with lesser size of dataset. 400 image samples (200 healthy, 200 diseased) of apple leaves have been used to train and validate the performance of the proposed model. The proposed model achieved an accuracy of 98%. To achieve this accuracy, it uses lesser data-set size as compared to other existing models, without compromising with the performance, which become possible due to use of contrast stretching pre-processing combined with FCM clustering algorithm.

Impact of the Affordable Care Act’s Physician Payments Sunshine Act on Physician Prescribing

Financial relationships between physicians and the pharmaceutical industry in the U.S are an impediment to the affordability and cost transparency of prescription medications. As part of the Affordable Care Act, the Physician Payments Sunshine Act (PPSA) requires medical product manufacturers including pharmaceutical companies to disclose to the Centers for Medicare and Medicaid Services (CMS) any payments made to physicians, starting in 2013. We evaluate the impact of the PPSA on physician prescribing of brand versus generic drugs in two drug classes: statin and antidepressants. We adopt a difference-in-differences and event study design, leveraging as the control group physicians in two states, MA and VT, which implemented similar state laws prior to the national PPSA. To address selection bias, our analytical sample includes physicians practicing in border counties between the treatment (NH, NY, RI) and control (MA, VT) states. Using 2011-2015 commercial insurance claims data from Health Care Cost Institute, we find that the PPSA led to a 26% reduction in new prescriptions of brand-name statin, and a 12% reduction in new prescriptions of brand-name antidepressants over the study period. We also find small to insignificant decrease in generic prescribing in both drug classes. The reduction in branded prescriptions occurred among physicians with all levels of industry payments in the post-PPSA period, and more pronounced among physicians with the highest level of drug spending pre-PPSA. The changes were primarily driven by physicians decreasing number of patients receiving drugs on an annual basis. We do not find evidence that the PPSA changed the clinical case-mix of patients receiving drugs. We estimate that the PPSA led to annual savings of approximately $0.8 million for statin and $0.4 million for antidepressant new prescriptions in the treated counties of our analytical sample alone.

Effect of vulcanization systems on the properties of natural rubber latex films

Natural rubber latex (NRL) films have high elasticity and flexibility and are excellent protection barriers against micro-organisms. For this reason, NRL is often used in the manufacture of medical products, such as gloves, condoms, blood transfusion tubes and catheters. The objective of this study was to evaluate the effect of two accelerators, ZDEC and TMTD, of the sulphur-based curing system, on the rheometric, crosslink density, thermal and mechanical properties. For this purpose, the compositions of NRL films were designed using two-level factorial design with a centre point, considering the variation from − 1 to + 1 of the levels of sulphur and accelerators. The results indicated that the delta torque was influenced by the addition of sulphur only. Scorch time (Ts1) and optimum vulcanization time (T90) decreased as TMTD was added to the formulations. TMTD only contributed to the crosslink density when low amounts of sulphur were used. Higher values of tensile strength were observed for sulphur, ZDEC and TMTD amounts, but it was close to the centre point experiments. SEV and EV vulcanization systems did not necessarily produce crosslinks that require higher energy to brake when compared to CONV system.

Antibacterial polyethylene - Ethylene vinyl acetate polymeric blend by incorporation of zinc oxide nanoparticles

In this work, a Low-Density Polyethylene (LDPE) - Ethylene Vinyl Acetate (EVA) polymeric blend with antimicrobial activity was obtained. The main objective was to develop an antibacterial LDPE-EVA polymeric blend from the incorporation of antibacterial nanoparticles to increase the antimicrobial and sanitary safety of this polymeric blend when applied in the manufacture of medical products. The antibacterial activity was obtained from the incorporation of zinc oxide nanoparticles (ZnO-NPs) in the LDPE-EVA polymeric blends and the thermal properties were evaluated by differential scanning calorimetry and the mechanical properties by tensile stress tests for different percentages of ZnO-NPs. Scanning electron microscopy was used to study the morphological characteristics of the ZnO-NPs and also the characteristics of the distribution of nanoparticles in the polymer blends. The dispersive energy of x-ray fluorescence spectroscopy was used to study the chemical composition of the nanoparticles. Microbiological tests were performed to evaluate the antibacterial activity of the LDPE-EVA polymeric blends without and with ZnO-NPs against the bacteria Staphylococcus aureus (gram-positive) and Escherichia coli (gram-negative). The results obtained were excellent for the future application of the antibacterial LDPE-EVA polymeric blends to the manufacture of medical products. The Young's modulus values decreased and the tensile strength values showed small reductions and the thermal properties of the LDPE-EVA were not modified. However, the antibacterial activity of LDPE-EVA with 4 wt% of ZnO-NPs was excellent, eliminating the gram-positive bacteria in just 2 h and the gram-negative bacteria in just 2.5 h on their surfaces.

Incidence of Serious Infections and Design of Utilization and Safety Studies for Biologic and Biosimilar Surveillance.

There is a need for postmarketing evidence generation for novel biologics and biosimilars. To assess the feasibility, strengths, and limitations of the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) Distributed Research Network (DRN) to examine the utilization and comparative safety of immune-modulating agents among patients with autoimmune diseases. We conducted a retrospective cohort study among patients enrolled in health insurance plans participating in the BBCIC DRN between January 1, 2006, and September 30, 2015. Eligible patients were adult (≥18 years) new users of a disease-modifying nonbiologic and/or biologic agent with a prior diagnosis of rheumatoid arthritis (RA), other inflammatory conditions (psoriasis, psoriatic arthritis, ankylosing spondylitis), or inflammatory bowel disease (IBD). Follow-up started at treatment initiation and ended at the earliest of outcome occurrence (serious infection); treatment discontinuation; or switching, death, disenrollment, or end of study period. The study leveraged the FDA Sentinel System infrastructure for data management and analysis; descriptive statistics of patient characteristics and unadjusted incidence rates of study outcomes during follow-up were calculated. Eligible patient drug episodes included 111,611 with RA (75% female), 61,050 with other inflammatory conditions (51% female), and 30,628 with IBD (52% female). Across all 3 cohorts, approximately half of the patient drug episodes initiated a biologic (50% in RA; 60% in psoriasis, psoriatic arthritis, ankylosing spondylitis; and 55% in IBD). The crude incidence rate of serious infection was 9.8 (9.5-10.0) cases per 100 person-years in RA, 7.1 (6.8-7.5) in other inflammatory conditions, and 14.2 (13.6-14.8) in IBD patients. This study successfully identified large numbers of new users of biologics and produced results that were consistent with those from earlier published studies. The BBCIC DRN is a potential resource for surveillance of biologics. This study was funded by the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC). HealthCore conducted this study in collaboration with Harvard Pilgrim Health Care. Zhang and Sridhar were employed by HealthCore at the time of this study. Haynes is employed by HealthCore funded by PCORI, the NIH, and the FDA. Barr and Eichelberger were employed by AMCP at the time of this study. Lockhart is employed by the BBCIC. Holmes and Clewell are employed by AbbVie. Accrott is an employee of and shareholder in Amgen. Marshall and Brown are employed by Harvard Pilgrim Health Care. Barr is a shareholder in Roche/Genentech. Curtis has received research grants from and consults with the following: Amgen, AbbVie, BMS, CORRONA, Lilly, Janssen, Myriad, Pfizer, Roche, Regeneron, and UCB. Brown has received research grants from GSK and Pfizer and consulting fees from Bayer, Roche, and Jazz Pharmaceuticals, along with funding from the Reagan-Udall Foundation for the FDA to conduct studies for medical product manufacturers, including Eli Lilly, Novartis, Abbvie, and Merck. Brown is also funded by PCORI, the NIH, and the FDA. McMahill-Walraven subcontracts with Harvard Pilgrim Health Care Institute for public health and safety surveillance distributed data network activtities and with the FDA, GSK, and Pfizer. She also reports fees from Reagan Udall Foundation for the FDA and the Patient Centered Outcomes Research Institute.

Minding the Gaps in Regulation of Do-it-Yourself Biotechnology

This Symposium confronts the reality that genetic technologies – not just genetic tests, but tools for altering plant, animal, and human genomes – are rapidly becoming and indeed already are consumer technologies. People can experiment with and apply these technologies in disintermediated formats, potentially without the involvement of national research funding agencies, professional scientists, physicians, genetic counselors, regulators, and traditional medical product manufacturers. The framework of 20th -century medical product and practice regulations assigned each of these parties a role in promoting ethical, safe, and effective biomedical research and health care. Do-it-yourself biotechnology (DIYbio), which includes direct-to-consumer (DTC) and do-it-yourself (DIY) genomic technologies, threatens to disrupt these roles. This raises concerns about how to protect consumer safety, the safety of research participants, and environmental and public safety to the extent these technologies are deployed in uncontained, open-release applications. Some of these concerns relate to the mechanics of regulation – for example, how to stretch existing regulatory principles and authorities to cover novel products and delivery pathways. Yet these technologies also raise questions about the very goals of regulation, forcing us to reexamine first principles such as, “What is the regulatory enterprise trying to accomplish?” This Article touches on both these themes before concluding that some of the gaps in the current regulatory framework for DIYbio are appropriate and ought to be preserved.

Analysis of regulatory requirements of medical devices and in-vitro diagnostics worldwide for the development of an efficient procedure of registration for manufacturers of medical products

Abstract Due to globalization and the quick development of technology, each government aims to ensure the safety and performance of products brought to their markets to protect its population. The peoples’ health state is of great significance and influenced easily by the quality of medical products. Therefore governments enact laws, directives and regulations to assure that quality. Nevertheless, these regulations can impede innovation and create trade barriers which result in an adverse effect on national economies. Where in some states no regulatory system is installed, others have highly sophisticated registration requirements that must be met. These diversities result in a challenge especially for small and medium sized companies, whose resources are often limited. [1] Manufacturers must control these diverse regulatory requirements by analyzing each market. Therefore an efficient procedure of registration should be defined that streamlines different registration requirements and ensures regulatory compliance. Next to regulatory authorities describing these requirements also harmonization groups play an important role in the design of the global regulatory landscape. Therefore also the most important harmonization groups and their current activities were investigated. The analysis showed that the impact of harmonization groups can be identified easily since new defined or updated regulatory requirements are oriented on their guideline. Still the harmonization of regulatory requirements in the medical device sector is not sufficiently enhanced. Thus the confrontation with each national regulatory system is inevitable.

МЕТОДИКА УПРАВЛІННЯ РИЗИКАМИ ДЛЯ СИСТЕМИ УПРАВЛІННЯ ЯКІСТЮ ПРИ ВИГОТОВЛЕННІ ВИРОБІВ МЕДИЧНОГО ПРИЗНАЧЕННЯ

Метою статті є розробка методичних рекомендацій, щодо створення методики управління ризиками при розробленні, підтриманні та управлінні системою управління якістю, відповідно до вимог міжнародного стандарту ISO 13485:2016 «Вироби медичні. Системи управління якістю. Вимоги щодо регулювання». У статті розглянуті етапи та алгоритм створення методики оцінювання та управління ризиками, яка необхідна для створення системи управління якістю при виробництві виробів медичного призначення. Для оцінювання ймовірності настання збитку застосовують постійну 5-ти бальну шкалу описових рівнів ймовірності, яка визначається і характеризується експертами перед проведенням оцінки ймовірностей збитків встановлених небезпек, що виникають при використання певного медичного виробу.

Regulatory interfaces surrounding the growing field of additive manufacturing of medical devices and biologic products.

Rapidly advancing technology often pulls the regulatory field along as it evolves to incorporate new concepts, better tools, and more finely honed equipment. When the area impacted by the technological advancement is regulated by the Food and Drug Administration (FDA), a gap develops between the technology and the guidelines that govern its application. Subsequently, there are challenges in determining appropriate regulatory pathways for evolving products at the initial research and developmental stages. Myriad factors necessitate several rounds of iterative review and the involvement of multiple divisions within the FDA. To better understand the regulatory science issues roiling around the area of additive manufacturing of medical products, a group of experts, led by a Clinical and Translational Science Award working group, convened the Regulatory Science to Advance Precision Medicine at the Fall Forum to discuss some of the current regulatory science roadblocks.

Interactive Implants: Ethical, legal and social implications

Abstract The use of intelligent implants and prostheses offers significant advances for optimizing medical treatment methods and is combined with an increasing technological modification of human body. This raises many exciting questions concerning law, ethics and social implications: Does the use of these techniques stay in line with our legal system and if yes, can the technical use be limited by governmental restrictions under certain conditions? Have moral values to be incorporated into technical artifacts? If machines are recreated from human beings, do they have to be provided with a legal subjectivity? Medical devices must be compatible with a high level of protection of health and safety. Therefore challenges, which are consequences of the indeterminate behaviour and the autonomous learning abilities of artificial intelligence, have to be faced. For avoidance of any hazards for legally protected rights medical product manufacturers have to assume legal duties, which affect construction, instruction and product development. For medical professionals there are also liabilities of maintenance measures and technical control that have to be accomplished. Associated with the use of intelligent medical devices is the processing of personal data on health. Health data have a high potential for misuse and discrimination and therefore they’re in need of special protection, particularly with regard to the development of “Big Data”, “Ubiquitous computing”, “Internet of Things” and constantly increasing cybercrime. If damages are suffered from the use of intelligent medical devices, difficulties in determining infringing acts, causality and culpability occur, especially because of the missing view into the technical progress of decision-making. It has to be explored, if the current liability law is able to assign responsibility adequately, otherwise there has to be found an appropriate concept for liability.

ELECTROLYTE-PLASMA POLISHING OF TITANIUM AND NIOBIUM ALLOYS

Titanium and niobium alloys are widely used at present in aircraft, nuclear energy, microwave technology, space and ultrasonic technology, as well as in manufacture of medical products. In most cases production technology of such products involves an implementation of a quality polishing surface. Mechanical and electrochemical methods are conventionally used for polishing products made of titanium and niobium alloys. Disadvantages of mechanical methods are low productivity, susceptibility to introduction of foreign particles, difficulties in processing complex geometric shapes. These materials are hard-to-machine for electrochemical technologies and processes of their polishing require the use of toxic electrolytes. Traditionally, electrochemical polishing of titanium and niobium alloys is carried out in acid electrolytes consisting of toxic hydrofluoric (20–25 %), sulfuric nitric and perchloric acids. The disadvantage of such solutions is their high aggressiveness and harmful effects for production personnel and environment. This paper proposes to use fundamentally new developed modes of electrolytic-plasma treatment for electrolyte-plasma polishing and cleaning products of titanium and niobium alloys while using simple electrolyte composition based on an aqueous ammonium fluoride solution providing a significant increase in surface quality that ensures high reflectivity. Due to the use of aqueous electrolyte the technology has a high ecological safety in comparison with traditional electrochemical polishing. The paper presents results of the study pertaining to the effect of titanium and niobium electrolytic-plasma polishing characteristics using the developed mode for productivity, processing efficiency, surface quality, and structure and properties of the surface to be treated. Based on the obtained results, processes of electrolytic-plasma polishing of a number of products made of titanium alloys BT6 (Grade 5), used in medicine and aircraft construction, have been worked out in the paper.