Best practices in the field of specific risk evaluation of pyrotechnic entertainment articles subject to legal and illegal market surveillance

The field of pyrotechnic articles is very popular and developed, and as a result, the influx of pyrotechnic articles on the market is abundant. However, it should be noted that in addition to compliant products, which meet the applicable essential safety requirements covered by Directive no. 2013/29 / EU, there are also products on the market that can present a significant level of danger when used, handled, transported or stored. Market surveillance authorities frequently find non-compliant products such as pyrotechnic articles offered to the public, some on the legal market, others traded illegally. The establishment of presumptive risks related to pyrotechnic articles can be achieved by applying documented and accredited procedures at national and European level by specialized laboratories, one of these being found within INSEMEX. Technical-scientific expertise activity aims to verify the level of security for products considered suspicious. We have an international collaboration with European authorities, and at the national level, requests for products such as pyrotechnic articles are sent for expertise by the police, the prosecutor’s office or the courts. It was found that most products considered “suspicious” had serious deficiencies that could lead to major risks, and those traded illegally lead to considerable economic losses.

Technical – organizational measures for classifying pyrotechnic articles

Pyrotechnic articles shall be classified by manufacturers according to their type of use, their purpose and their level of risk, including their noise level, and the notified bodies shall confirm the classification as part of the conformity assessment procedures. In accordance with the relevant national legislation, the national authority must take all appropriate measures to ensure that pyrotechnic articles do not endanger the health and safety of persons. If the national market surveillance authority has sufficient reasons to consider that a pyrotechnic article poses a risk to the health, safety of persons or other aspects of the protection of the public interest, it shall carry out an assessment of the pyrotechnic article concerned. INCD INSEMEX Petrosani is an accredited institution, to carry out such technical expertise according to the legislation in force harmonized with the European regulations, having also adequate modern facilities for fulfilling the requirements of the standards in the field. The paper also highlights the results of the modernization of the methodological and practical infrastructure as well as the technical facilities that underlie the substantiation of the new approach in terms of optimizing and increasing the quality of the process.

Twelve-Month Outcomes From the Japanese Post-Market Surveillance Study of the Viabahn Endoprosthesis as Treatment for Symptomatic Peripheral Arterial Disease in the Superficial Femoral Arteries

Purpose: To assess the midterm safety and effectiveness of the Gore® Viabahn® Endoprosthesis as treatment for symptomatic peripheral arterial disease (PAD) in the superficial femoral arteries (SFA). Materials and Methods: A prospective, multicenter, post-market surveillance study was conducted in Japan. Patients with symptomatic SFA lesions ≥ 10 cm and reference vessel diameters ranging from 4.0 to 7.5 mm were eligible for enrollment; patients with traumatic or iatrogenic vessel injury in the thoracic, abdominal, or pelvic arteries were excluded. Outcomes evaluated at 12 months were primary patency (PP), primary-assisted patency (PAP), secondary patency (SP), freedom from target lesion revascularization (fTLR), occurrence of device- or procedure-related serious adverse events (SAEs), and stent fractures. Results: From August 2016 to May 2017, 321 patients were enrolled at 64 Japanese sites (mean age, 73.9±8.7 years; 77.3% male). Hypertension, diabetes, and end stage renal disease were present in 84.4%, 54.8%, and 23.1% of patients, respectively. Mean lesion length was 23.6 cm±6.6 cm, with lesions ≥ 15 cm in 271 patients (84.4%). TASC C/D lesions accounted for 86.6% (39.1% TASC C, 47.5% TASC D); 26.5% had critical limb ischemia. Baseline ABI was 0.60±0.16. A total of 562 devices were implanted in 324 limbs, with a majority of patients (68.8%) receiving 2 stents. Through 12 months, 92.1% of patients were evaluable. Kaplan-Meier-estimated PP, PAP, and SP at 12 months was 85.6%, 91.7%, and 94.8%, respectively. Twelve-month fTLR was 92.3%. Mean change in ABI at 12 months was 0.343±0.21; mean improvement in Rutherford class was 2.5. Device- or procedure-related SAEs occurred in 3.1% through 30 days, with a majority of early SAEs consisting of access complications. Through 12 months, a cumulative 10.6% had device- or procedure-related SAEs, with the most common being device occlusions in 4.0%. Lower limb amputation occurred in 0.9% and was related to pre-existing ulceration or gangrene in all 3 cases. No stent fractures were observed at 12-month x-ray evaluation. Conclusion: In a real-world Japanese patient population characterized by long SFA lesions and complex PAD, the Viabahn endoprosthesis was associated with excellent patency rates through 12 months and an acceptable safety profile.

Certification of Unmanned Aircraft Systems – from product safety to type certificate – a review about the operation of the EU safeguard processes

Significant changes are emerging in the market of unmanned aircraft systems since 2019 through the publication of two specific regulations that regulate all steps of the use of unmanned aerial vehicles in detail. With the implementation of the new EU drone regulations, the role of the notified bodies and the certification agencies will be more important from the viewpoint of product safety and the official certification required by the EU and national aviation authorities. The product safety chain consists of two major parts. One part belongs to the production phase, where the manufacturer has to prove the functionality (it is called the conformity assessment) and another part belongs to the distribution market, where the authorities assess the fulfilment of the conditions of the distribution (it is called the market surveillance). The first pillar concern to the design and manufacturing and the second to the distribution. Each segment is presented in this article and the authors introduce the different control approaches of these segments. It has to be taken into consideration that the drones are representing a special market with notable safety risks that have to be handled during the whole lifepath of the products from the design through the distribution until the aerial operations.

The European Union Artificial Intelligence Act: the first look at the project

The proposal of European Union Regulation establishing harmonized rules for artificial intelligence (Artificial Intelligence Act) is under consideration. The structure and features of the draft of this regulatory legal act of the integration organization are analyzed. Thus, the act will contain harmonized rules for the commissioning, operation and use of AI systems; bans on certain artificial intelligence methods; special requirements for high-risk AI systems and the obligations of the operators of such systems, harmonized transparency rules for AI systems intended for interaction with individuals, emotion recognition systems and biometric categorization systems, AI systems used to create images, audio or video content, or managing them; market surveillance and supervision rules. The article discusses other provisions of the Act, the features of the proposed institutions (In particular, the European Council on Artificial Intelligence should be created) and norms, including extraterritoriality, risk-based approach, object, scope, definitions, punishment for violations of provisions. The possibility of voluntarily complying with codes of conduct for some AI systems is highlighted. Conclusions are drawn about the advisability of (non) application of these institutions or rules in the Russian Federation.

European Artificial Intelligence Act: Should Russia Implement the Same?

The proposal for a European Union Regulation establishing harmonized rules for artificial intelligence (Artificial Intelligence Act) is under consideration. The structure and features of the proposal of this regulatory legal act of the integrational organization are analyzed. EU AI Act scope is analyzed and shown as wider than the current Russian one. The act will contain harmonized rules for placing into market, operation and use of AI systems; bans on certain artificial intelligence methods; special requirements for AI systems with high level of risk and obligations of operators of such systems, harmonized transparency rules for AI systems designed for interaction with individuals, emotion recognition systems and biometric categorization systems, AI systems used to creating or managing images, audio or video content; market surveillance and supervision rules. The provisions of the Act, the features of the proposed institutions and norms, including extraterritoriality (as for GDPR before that raised many questions), risk-oriented approach (which is based both on self-certification and definite criteria for high-risk systems), object, scope, definitions are considered. The possible key concerns based on case-law to undermine possible discrimination are expressed. The author expresses conclusions about the advisability of (non) application of these institutions or rules in Russia.

Quality of Alcohol Based Hand Sanitizers Marketed in the Nairobi Metropolis

The emergence of the COVID-19 pandemic has propelled the use of alcohol-based hand sanitizers to the fore as a SARS-CoV-2 control measure. To be effective these products must comply with relevant quality parameters such as alcohol concentration, methanol limits and purity. The current study was designed to determine the quality of alcohol-based hand sanitizer products in the Nairobi metropolitan area. For this purpose, 74 commercially marketed samples were collected and subjected to analysis by gas chromatography. Only three samples (4.1%) complied with the regulatory specifications for alcohol content, methanol limits and pH. Five samples (6.8%) complied with the specification for alcohol content but did not meet methanol or pH limits. A total of 44 (59.5%) samples had methanol levels that exceeded threshold limits. Eleven samples (14.9%) were found with methanol substitution (i.e., methanol, instead of ethanol or isopropanol, was the main alcohol component). The results show that users of alcohol-based hand sanitizers are being exposed to substandard and falsified products which in addition to being non-efficacious pose harm due to unacceptable levels of toxic impurities. Regular, routine post-market surveillance is needed to prevent such products from reaching the market.

Post-Market Surveillance of a Blood Glucose Test Strip Demonstrates No Evidence of Interference on Clinical Accuracy in a Large Cohort of People with Type 1 or Type 2 Diabetes

Background Regulations and industry guidance relating to testing for interference in blood glucose monitoring (BGM) systems continue to focus on in vitro laboratory bench tests. Post-market surveillance (PMS) in a clinical setting allows for BGM accuracy assessments to evaluate the impact of real-world exposure to polypharmacy in people with diabetes. This study evaluated the OneTouch Select Plus® BGM test-strip accuracy with respect to polypharmacy using a clinical registry dataset. Methods Medication profiles were analysed for 1023 subjects (425 with type 1 (T1D) and 598 with type 2 diabetes (T2D)) attending 3 UK hospitals. Blood samples were analysed to determine clinical accuracy of the BGM test-strip against a laboratory comparator. Results 538 different medications (48 diabetes and 490 non-diabetes) were recorded across the 1023 subjects. Patients took on average 6.9 ( n = 1-36) individual medications and 4.1 ( n = 1-13) unique medication classes. Clinical accuracy to EN ISO 15197:2015 criteria were met irrespective of increasing average number of individual medications, categorized from 1-3, 4-6, 7-9, 10-12 and >12 taken per subject (97.7%, 97.7%, 97.8%, 97.8%, and 98.4%, respectively). Clinical accuracy criteria were met across 15 classes of medication using the combined dataset (97.9%; 29784/30433). Surveillance Error Grid (SEG) analysis showed 98.7% (29959/30368) of readings presented no clinical risk. No individual class or combination of medication classes impacted clinical accuracy of the BGM test-strip. Conclusions Clinical performance for the test strip under assessment demonstrated no evidence of interference from over 500 prescription medications, with clinical accuracy maintained across a range of polypharmacy conditions in people with diabetes.