[Implant anchorage: In vivo and in vitro analyses : Clusters for implant anchorage and safety]. / Implantatverankerung: In-vivo- und In-vitro-Analysen : Cluster Implantatverankerung und -sicherheit.

Aseptic implant loosening is the primary cause of revisions in arthroplasty. Various in vitro and in vivo methods are available for assessing implant fixation and stability. The aim of the Musculoskeletal Biomechanics Research Network (MSB-NET) is to continuously improve or develop these methods. In vitro analyses are often conducted using static and dynamic ISO and ASTM standards, while RSA, DXA, and EBRA analyses are established in vivo methods for evaluating implant fixation. Primary stability analyses, as well as acoustical methods, provide additional opportunities to detect loosening early and precisely evaluate implant stability. The cluster serves as a link between basic research, clinical practice, and end users to promote in vitro and in vivo methods to improve implant safety.

A Pilot Study Assessing Common Medication Organizers for Child-Resistant Features.

Introduction: Prescription and most over-the-counter medicines are required to have child-resistant packaging and/or labeled with instructions "Keep out of reach of children." Although medication organizers are not required to have such design features or instructions, these could help prevent unsupervised ingestions by children. Commonly purchased medication organizers were evaluated for child-resistant design features and instructions for safe use to prevent unsupervised ingestions. Methods: The 29 best-selling medication organizers on Amazon.com were identified, and product identifiers, design characteristics, and safety characteristics were recorded using a standardized instrument. Results: Of the 29 medication organizers, none claimed to be child resistant. Only 31% provided a specific warning that the organizer was not child resistant on the packaging; only 41% communicated "Keep out of reach of children." Most organizers (59%) provided neither a warning that the organizer was not child resistant nor instructions to store out of reach of children. The majority of organizers (79%) shared the following characteristics: plastic construction, rectangular shape, nonelectronic flip-top opening mechanisms, and 7-day usage. Conclusions: Opportunities exist for manufacturers of medication organizers to improve child-resistant product design, provide information to help prevent unsupervised ingestions (directions to keep the device out of the reach of children), and help to reduce unsupervised ingestions.

Medical data market platforms and medical data trade demands of medical device companies.

Objective: The significance of big data is increasingly acknowledged across all sectors, including medicine. Moreover, the trend of data trading is on the rise, particularly in exchanging other data for medical data to rejuvenate the medical industry. This study aimed to discern the facilitating factors of healthcare data trade. Methods: We assessed five medical data market platforms on October, 2022, based on three criteria: (a) clarity in articulating the data for sale; (b) transparency in specifying the data costs; and (c) explicit indication that payment grants data access. This helped identify the traded medical data types. Additionally, we anonymously surveyed 43 representatives from medical device companies about their demand for medical data trading, achieving a response rate of 66%. Results: Of the medical data traded on these platforms, 93.34% was structured, while 5.66% was unstructured, indicating an imbalance. Although there was a higher demand for structured medical data, there was also interest in purchasing unstructured medical data. Conclusion: Unstructured big data are crucial for medical device development, fueling the demand for trading such data. Many stakeholders view the data market as essential and are willing to procure medical data. Consequently, medical device companies will need methods to acquire unstructured medical data for developing innovative and enhanced medical devices.

A comparative study of medical device regulation between countries based on their economies.

INTRODUCTION: Medical devices play a crucial role in healthcare, addressing the diagnosis, treatment, and monitoring of various medical conditions. This study conducts a comprehensive analysis of medical device regulations across nations, considering the economic contexts of diverse countries. AREAS COVERED: The research involves a comparative examination of medical device regulations, dissecting unique frameworks in countries like the United States (US), European Union (EU), India, and Africa. These nations were chosen based on economic significance, market influence, and regulatory structures. The study aims to achieve a nuanced understanding of global medical device regulation, develop strategies to enhance guidelines, especially in developing nations, and provide recommendations for improvements in relevant regions. EXPERT OPINION: Through this study, valuable insights are gained into the diverse regulatory frameworks governing medical devices globally. The analysis identifies areas within these frameworks that require improvement, as well as strategies to enhance regulatory guidelines, particularly addressing the specific needs of developing economies. Ultimately, the research provides significant recommendations for policymakers and industry stakeholders. By offering a deeper understanding of regulatory intricacies, this study establishes pragmatic approaches to address challenges within the medical device industry and improve the regulatory landscape on a global scale.

Study on the impact of sensitization on materiovigilance programme among pharmacy and dental post graduate students.

BACKGROUND: Medical devices play a crucial role in patient care but entail inherent risks, necessitating the presence of Materiovigilance to monitor and prevent medical device adverse events (MDAEs). The primary objective of our study is to evaluate the impact of an awareness and sensitization program regarding medical devices among participants. METHODS: A self-administered, validated knowledge, attitude and practice (KAP) questionnaire consisting of 15 questions was distributed to 182 participants, and their responses were collected. The data were analyzed using SPSS software version 18. RESULTS: Out of the 182 responses received, 56% were from the Pharmacy, while 44% were from the Dental field. 64.8% of the participants were unaware of the Materiovigilance Programme of India (MVPI). However, an overwhelming 97.5% displayed a positive attitude toward reporting MDAEs. Only 5% of the participants had received training on how to report MDAEs. Furthermore, approximately 85.71% of participants had not seen the MDAE reporting form. CONCLUSION: To improve the reporting of adverse events associated with medical devices, it is essential to implement educational interventions and provide training to Pharmacy and Dental postgraduate students. These measures will increase awareness and promote better understanding and implementation of Materiovigilance practices.

Development and application of a protocol for extractables profiling from central venous catheters in neonates.

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.

Signs and symptoms: Adverse events associated with a sterilization device.

Sterilization is now the most common contraceptive method used by women of in the U.S., and sterilization devices have played an important role in its increased popularity. This mixed methods study examines a random sample of 2500 U.S. Food and Drug Administration (FDA) adverse event reports made between 2006 and 2017 about Essure, a sterilization device. Quantitative coding was used to examine patient problems; pain and bleeding were reported most frequently. Qualitative coding analyzed impacts of symptoms on patients' everyday lives and patients' healthcare experiences, including intimate relationships, mothering, and paid employment. Findings suggest that some patients struggled when their reported "subjective" symptoms didn't result in "objective" clinical signs of problems, and when physicians dismissed or deflected their concerns in diagnostic encounters. This paper raises important issues regarding the symptoms patients associated with Essure, the diagnosis of device-driven disease and injury, and the FDA's regulation of medical devices.

Medical Device-Associated Biofilm Infections and Multidrug-Resistant Pathogens.

Medical devices such as venous catheters (VCs) and urinary catheters (UCs) are widely used in the hospital setting. However, the implantation of these devices is often accompanied by complications. About 60 to 70% of nosocomial infections (NIs) are linked to biofilms. The main complication is the ability of microorganisms to adhere to surfaces and form biofilms which protect them and help them to persist in the host. Indeed, by crossing the skin barrier, the insertion of VC inevitably allows skin flora or accidental environmental contaminants to access the underlying tissues and cause fatal complications like bloodstream infections (BSIs). In fact, 80,000 central venous catheters-BSIs (CVC-BSIs)-mainly occur in intensive care units (ICUs) with a death rate of 12 to 25%. Similarly, catheter-associated urinary tract infections (CA-UTIs) are the most commonlyhospital-acquired infections (HAIs) worldwide.These infections represent up to 40% of NIs.In this review, we present a summary of biofilm formation steps. We provide an overview of two main and important infections in clinical settings linked to medical devices, namely the catheter-asociated bloodstream infections (CA-BSIs) and catheter-associated urinary tract infections (CA-UTIs), and highlight also the most multidrug resistant bacteria implicated in these infections. Furthermore, we draw attention toseveral useful prevention strategies, and advanced antimicrobial and antifouling approaches developed to reduce bacterial colonization on catheter surfaces and the incidence of the catheter-related infections.

How to choose between single-use and reusable medical materials for sustainable nursing: Methodological lessons learned from a national study.

AIM: To demonstrate and reflect upon the methodological lessons by which healthcare organizations can address questions of environmental sustainability related to single-use healthcare materials. DESIGN: A cross-sectional multi-centre study in hospitals was performed, followed by an exploratory analysis of the sustainability of commonly used healthcare materials. METHODS: A hospital survey was conducted to collect the procurement data for single-use medical materials. Based on consumption and cost, five single-use medical materials with sustainable alternatives were selected using different reuse strategies. Single-use and reusable materials were assessed through an exploratory literature review and document study based on four parameters: environmental sustainability, safety, cost and efficiency. RESULTS: A pragmatic method emerged from this study, providing healthcare facilities with tools to select environmentally sustainable alternatives to replace single-use options. First, an inventory of single-use medical materials consumed was collected. Next, single-use materials were prioritized for further study based on criteria such as cost, volume of the material, feasibility and input of stakeholders. We then analysed the prioritized single-use materials and their alternatives based on life cycle assessments or available information on their different life stages. Finally, we assessed safety, costs and efficiency related to the process following the use of the medical material. CONCLUSION: This pragmatic method can guide healthcare institutions in making the most sustainable choices of medical materials and achieving sustainability goals within their institutions and nationwide. IMPACT: Patient care involves a large consumption of single-use medical materials with considerable environmental impact. A pragmatic method was developed to guide healthcare institutions in making the most sustainable choices regarding the use of single-use healthcare materials. Healthcare institutions, ideally represented by a green team including nurses and other relevant professionals, can use this method to reduce the use of single-use medical materials, thereby yielding positive outcomes for the entire population. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.

Examining labelling guidelines for AI-based software as a medical device: A review and analysis of dermatology mobile applications in Australia.

In recent years, there has been a surge in the development of AI-based Software as a Medical Device (SaMD), particularly in visual specialties such as dermatology. In Australia, the Therapeutic Goods Administration (TGA) regulates AI-based SaMD to ensure its safe use. Proper labelling of these devices is crucial to ensure that healthcare professionals and the general public understand how to use them and interpret results accurately. However, guidelines for labelling AI-based SaMD in dermatology are lacking, which may result in products failing to provide essential information about algorithm development and performance metrics. This review examines existing labelling guidelines for AI-based SaMD across visual medical specialties, with a specific focus on dermatology. Common recommendations for labelling are identified and applied to currently available dermatology AI-based SaMD mobile applications to determine usage of these labels. Of the 21 AI-based SaMD mobile applications identified, none fully comply with common labelling recommendations. Results highlight the need for standardized labelling guidelines. Ensuring transparency and accessibility of information is essential for the safe integration of AI into health care and preventing potential risks associated with inaccurate clinical decisions.

Chemical resistance testing of plastics - Material compatibility of detergent and disinfectant products.

BACKGROUND: Surface cleaning and disinfection is a key part of breaking the chain of transmission and reducing the risk of healthcare associated infections (HAIs). However, if cleaning and disinfectant formulations are incompatible with surface materials, frequent application can cause premature failure of plastics due to Environmental Stress Cracking (ESC). Material compatibility should be considered when selecting cleaning and disinfecting products. AIM: This study evaluates the tendency of 2-in-1 wet wipes to cause ESC in commonly found healthcare plastics. METHODS: Eight ready-to-use 2-in-1 wet wipes were evaluated for their ability to cause ESC in 13 plastic surfaces in accordance with BS EN ISO-22088-3. Polymers were exposed to fluid extracted from wipes at a fixed strain of 0.5% for 7 days and assessed for cracking, crazing, and tensile strength in accordance with ISO 527-2:2012. FINDINGS: All 2-in-1 wet wipes tested contained ESC agents, although the severity of ESC varied. Products with higher pH (>8.0) were responsible for 74% of failures, with 22 of the 39 tested plastics visibly cracking. Although the primary active in all tested wipe formulations were Quaternary Ammonium Compounds (QACs), formulations that included small/medium amines or alcohol demonstrated a greater propensity for plastic cracking. CONCLUSION: Each disinfectant formulation exhibits a unique spectrum of microbial efficacy and unique potential to cause surface damage. This may result in device failures and recalls that could compromise patient and staff safety. BS EN ISO-22088-3 can support material compatibility assessments of disinfectant and detergent products before they come to market.

Effectiveness and tolerability of rectal ointment and suppositories containing sucralfate for hemorrhoidal symptoms: a prospective, observational study.

BACKGROUND AND AIMS: A high number of topical products are available for the treatment of hemorrhoidal symptoms. Sucralfate-based topical products constitute a new treatment alternative that act as a mechanical barrier to facilitate healing. The aim of this prospective, observational study was to determine patient- and physician-assessed effectiveness and tolerability of rectal ointment and suppositories containing sucralfate for the treatment of hemorrhoidal symptoms in routine clinical practice. METHODS: Adult patients with diagnosed, mild-to-moderate, symptomatic non-bleeding hemorrhoids treated with rectal ointment or suppositories containing sucralfate were enrolled. Patients were administered treatment twice per day for at least 1 week until symptom resolution and/or for a maximum of 4 weeks. The primary endpoint was patient-assessed effectiveness on a modified Symptom Severity Score (mSSS, range 0 to 14). Physician-assessed effectiveness (9 symptoms, 0 to 5 Likert scale), hemorrhoid grade, and patient satisfaction were also determined. RESULTS: Five investigators enrolled 60 patients; mean age was 48.4 ± 16.6 years and 72.4% were female. Pain or pressure sensitivity was reported as the most severe symptom by patients, and pressure sensitivity, discharge, soiling, and prolapse by physicians. Mean patient-assessed mSSS at baseline was 6.6 ± 1.9 and was significantly improved overall and in the ointment and suppository groups individually by -4.6 ± 2.0, -4.4 ± 1.8, and -4.8 ± 2.2, respectively (p < 0.0001). Investigator-assessed mean baseline symptom score was 18.1 ± 3.9 and improved by -7.1 ± 4.5, -6.9 ± 5.4, and -7.3 ± 3.5, respectively (p < 0.0001). Investigator-assessed symptoms of pressure sensitivity, swelling, and discharge were improved to the greatest extent. Hemorrhoid grade was improved in 38% of patients at the end of treatment. Compliance with treatment was 97.4% and patient satisfaction with application and onset of action was high (81.3% and 76.2%, respectively). Both the ointment and suppository were well tolerated. CONCLUSIONS: The effectiveness of topical ointment or suppository containing sucralfate on patient- and investigator-assessed hemorrhoidal symptoms in real-life clinical practice was demonstrated. Patient satisfaction was high and treatments were well tolerated. Larger controlled trials are warranted to confirm the results.

Implementing a Barcode-Based Whole-Life Cycle Management Process to Improve Robotic Instrument Tracking.

Minimally invasive surgery can involve the use of robotics to improve patient outcomes. Some robotic systems require special instruments with a designated number of uses. In China, during the reprocessing of the robotic instruments, health care personnel determined that the existing tracking processes were inadequate. They conducted a quality improvement project with the goal of establishing a barcode-based standardized process for tracking robotic instruments. They implemented technology that generated a unique identifier each time a robotic instrument was reprocessed after use. Nurses scanned the identifier when surgeons used the instrument. The findings included the increased accuracy of use documentation and decreases in untraceable sterilization and use records, charging concerns, and average daily and monthly inventory times. An increase in adverse event reports associated with robotic instruments also was noted. The use of barcode technology for robotic instrument tracking continues at the facility and may be expanded for additional specialty instruments.

Robotic technology in surgery; a classification system of soft tissue surgical robotic devices.

BACKGROUND: The field of robotic-assisted surgery is rapidly growing as many robotic surgical devices are in development and about to enter the market. Currently, there is no universally accepted language for labeling the different robotic systems. To facilitate this communication, we created what is, to our knowledge, the first classification of surgical robotic technologies that organizes and classifies surgical robots used for endoscopy, laparoscopy and thoracoscopy. METHODS: We compiled a list of surgical robots intended to be used for endoscopy, laparoscopy, and/or thoracoscopy by searching United States, European, Hong Kong, Japan, and Korean databases for approved devices. Devices showcased at the 2023 Annual Meeting for the Society of Robotic Surgery were added. We also systematically reviewed the literature for any existing surgical robotic classifications or categorizations. We then created a multidisciplinary committee of 8 surgeons and 2 engineers to construct a proposed classification of the devices included in our search. RESULTS: We identified 40 robotic surgery systems intended to be used for endoscopy, laparoscopy and/or thoracoscopy. The proposed classification organizes robotic devices with regard to architecture, port design, and configuration (modular carts, multi-arm integrated cart, table-attachable or arm-table integration). CONCLUSION: This 3-level classification of robotic surgical devices used for endoscopy, laparoscopy and/or thoracoscopy describes important characteristics of robotic devices systematically.

Metric identification and mapping of reimbursable implant codes in Morocco to the Global Nomenclature (GMDN) and European (EUDAMED) of medical devices.

BACKGROUND: The list of medical devices (MD) eligible for reimbursement under the Compulsory Health Insurance in Morocco is set by Ministerial Order comprising 869 items between life-support equipment, external prostheses, and implants. The objective of the present study is to analyze the nomenclature of implantable medical devices (IMD) appearing on this list and compare them with the global nomenclature of MD (GMDN) and the European nomenclature of MD (EMDN). METHODS: The study deals with (i) the mapping of the codes of the IMD list with 170 DM per cardinality and (ii) a metric identification by Sørensen-Dice coefficient of terminological similarity of the IMD with respect to the two databases. RESULTS: The 170 IMD codes are mapped onto 493 terms in the GMDN and 344 terms in the EMDN. 37.7% of implants are mapped to more than or equal to 2 terms of GMDN while 36.5% are mapped to more than or equal to 2 terms to the EMDN. The comparison of cardinality distributions has revealed no significant difference (p = 0.430) between the two databases. The implants examined are divided into 11 categories whose strong similarity is given to active cardiovascular implants in the EMDN database with simDice=0.534. CONCLUSION: Healthcare authorities need to align with nomenclature standards to improve interoperability and rely on a more efficient and rational regulatory process.

Customized Silicone Foam Dressing Under Noninvasive Ventilation and Skincare Bundle to Reduce Hospital-Acquired Pressure Injuries in Neonates.

In a sixty-eight-bed level-IV NICU, an increased incidence of hospital-acquired pressure injuries (HAPIs) from noninvasive ventilation (NIV) devices was identified. The aim of this quality improvement project was to decrease HAPIs from NIV by 10%. A literature review and the Plan-Do-Study-Act were implemented. The intervention included a customized silicone foam dressing under NIV, an NIV skincare bundle, and multidisciplinary support. Hospital-acquired pressure injury rates were tracked over 3 years postinterventions. The incidence of HAPIs declined by 20% from 0.2 per 1,000 patient days to 0.05 per 1,000 patient days. Relative risk was 4.6 times greater prior to intervention (p = .04). Continuous positive airway pressure (CPAP) failure was not noted and measured by the percentage of patients on ventilators pre- and postintervention. Customized silicone foam dressings under NIV, NIV skincare bundle, and multidisciplinary team support may decrease HAPIs in neonates without CPAP failure.

Applications of Blockchain-Based Technology for Healthcare Devices Post-market Surveillance.

The volume of data analysis for medical device post-market surveillance (PMS) has increased dramatically in recent years. It is the more stringent and intricate regulatory criteria of the health authorities that are meant to improve the medical device safety review. As regulators scrutinize device safety more closely, proactive approaches to PMS processes are becoming crucial. To solve some of the issues brought on by this shifting regulatory landscape, new technologies have been investigated. This study envisages the technical features of blockchain technology (BCT) and its role in enhancing the PMS for medical devices. To address the aforementioned challenges, our model involves the establishment of a secure, permissioned blockchain for PMS data management, utilizing a proof-of-authority consensus mechanism. This blockchain framework will exclusively permit a carefully vetted and designated set of participants to validate transactions and record them in the PMS data ledger. The utilization of BCT holds the potential to introduce enhanced efficiency and provide several advantages to the various stakeholders involved in the PMS procedure, including its potential to support emerging regulatory efforts.

Regulating Laboratory Tests: What Framework Would Best Support Safety and Validity?

Policy Points With increasing public attention to cases of inaccurate and misleading laboratory-developed tests, there have been calls for regulatory reform. To protect patients from faulty laboratory tests, we need a framework that balances comprehensive test review with laboratory flexibility. The Verifying Accurate Leading-edge IVCT [In Vitro Clinical Test] Development (VALID) Act would have helped ensure laboratory test safety and validity through a much-needed expansion of Food and Drug Administration (FDA) oversight. However, Congress did not pass the VALID Act in 2022, forcing the FDA to start the regulatory reform process on its own.