Assessing Detergent Residuals for Reusable Device Cleaning Validations

Cleaning chemistries are detergent-based formulations that are used during the processing of reusable medical devices. Manufacturers are responsible for demonstrating the safety of cleaning formulations when they are used during a device processing cycle, including the risk of device-associated cytotoxicity over the concentration ranges for recommended use and rinsing during cleaning. However, no regulation currently exists requiring manufacturers to demonstrate such safety. Although manufacturers' safety data sheets (SDSs) provide information on the safe use of chemicals for users, this information may not provide sufficient detail to determine the risks of residual chemicals on device surfaces. SDSs are not required to contain a comprehensive list of chemicals used, only those of risk to the user. They should be supplemented with information on the correct concentrations that should be used for cleaning, as well as instructions on the rinsing required to reduce the levels of chemicals to safe (nontoxic) levels prior to further processing. Supporting data, such as toxicity profiles or cytotoxicity data that support the instructions for use, would provide medical device manufacturers and healthcare personnel with the necessary information to make informed decisions about selection and correct use of detergents. In the current work, cytotoxicity profiles for eight commonly used cleaning formulations available internationally were studied. Although all of these products are indicated for use in the cleaning of reusable medical devices, results vary across the serial dilution curves and are not consistent among detergent types. The information presented here can be leveraged by both medical device manufacturers and processing department personnel to properly assess residual detergent risks during processing. This work also serves as a call to cleaning formulation manufacturers to provide this information for all chemistries.

Inevitable Influences: AI-Based Medical Devices at the Intersection of Medical Devices Regulation and the Proposal for AI Regulation

In recent years, the use of Artificial Intelligence (AI) in the medical field has attracted increased attention. Due to their impressive advantages, AI systems offer excellent prospects for medical device manufacturers using these systems to upgrade their products. Such AI-based medical devices are already subject to partial regulation within the lines of Medical device regulation 745/2017. However, following the proposal for a regulation on artificial intelligence published by the European Commission, the regulatory landscape for these devices has partially changed. This article aims to clarify the influences that this regulatory intervention by the European Commission brings to the path towards the use and marketing of AI-based medical devices.

Biocompatibility of Medical Devices - A Review

BACKGROUND Biomaterial is defined as "any substance or combination of medicine, artificial or natural origin, which can be used at any time, in whole or part by a system that controls, adds to, or restores any tissue, organ or function". ISO 10993-1: 2018 standard defines bio compliance law as "the ability of a medical device or tool to perform a selected program with the acceptable response of experts". Incompatible factors cause chemical reactions in patients, with little or no side effects. The body can respond in a sort of way after the installation of medical devices, so testing and improvement is important here. Therefore, testing and improvement in this field are important. Biocompatibility is required for any significant use of components or materials in medical devices. Inconsistent factors create negative biological responses in patients, which may have serious consequences. Biomaterials are substances utilized in medical devices, especially in applications where the device is touched, temporarily embedded, or permanently implanted within the body. Because of the significant impact of biocompatibility, many countries have imposed regulations on medical device manufacturers to meet biocompatibility specifications. Here is a brief explanation about the biocompatibility and incompatibility parameters of medical devices with a human body and its need for biocompatibility of medical devices with the human body. Medical devices have improved doctors' ability to diagnose and treat disease, which has led to significant improvements in health and quality of life. Thus, medical devices are prone to various incompatibility issues and procedures that affect the biological environment must be followed. KEY WORDS Biocompatibility, Material Interactions, Sterilization, Medical devices, Biocompatibility Testing, Incompatibility Factors.

An Introduction to Robotically Assisted Surgical Systems: Current Developments and Focus Areas of Research

Purpose of Review Robotic assistance systems for diagnosis and therapy have become technically mature and widely available. Thus, they play an increasingly important role in patient care. This paper provides an overview of the general concepts of robotically assisted surgical systems, briefly revisiting historical and current developments in the surgical robotics market and discussing current focus areas of research. Comprehensiveness cannot be achieved in this format, but besides the general overview, references to further readings and more comprehensive reviews with regard to particular aspects are given. Therefore, the work at hand is considered as an introductory paper into the topic and especially addresses investigators, researchers, medical device manufacturers, and clinicians, who are new to this field. Recent Findings The current research in Robotically Assisted Surgical Systems (RASS) increasingly uses established robotic platforms. To minimize the patient trauma while optimizing the dexterity of the surgeon, miniaturized instruments and semi-autonomous assistance functions are developed. To provide the surgeon with all necessary information in an adequate manner, novel imaging sensors as well as techniques for multimodal sensory feedback and augmented reality are investigated. The Surgical Data Science applies data management and processing approaches including machine learning on medical data to provide optimal, individualized and contextual support to the surgeon. Summary Robotic systems will significantly influence future patient care. Since they must fulfill manifold medical, technical, regulatory and economic requirements, their development calls for a close, active and interdisciplinary cooperation between stakeholders from hospitals, industry and science.

Is Remote Human Factors Testing an Acceptable Approach for Human Factors Validation

Human factors (HF) validation of medical devices is vital for approval of use by the Food and Drug Administration (FDA). Historically, validation testing of medical devices has taken place within laboratory-controlled environments where conditions are controlled, and testing is executed in accordance with similar circumstance. Due to the COVID-19 pandemic, laboratory research has decreased in a wide range of disciplines or in instances continued with masks and many other COVID mitigations. As a result, medical device manufacturers who need to provide human factors validation to receive U.S. Food and Drug Administration (FDA) approval were impacted. Remote usability testing, while a fairly new phenomenon for physical devices, affords the ability to functionally test a product within naturalistic environments that are indistinguishable from the settings in which they would be used (e.g. the user’s home). However, published literature to support whether remote HF testing could potentially be an acceptable approach is rare. The objective of this study is to replicate the objectives and structure of an original in-person study, which was conducted using migraine patients who performed one unaided simulated injection using a 2-step autoinjector. The original methodology has been modified to adapt to the remote testing. This paper reports the procedures that has been developed for this ongoing endeavor.

Conflicts of Interest of Pediatric Journal Authors

The Physician Payments Sunshine Act requires disclosure of payments made by drug and medical device manufacturers to physicians or teaching hospitals. Academic literature extensively documents gender disparities in the medical profession with regard to salary, promotion, and government funded research. This investigation sought to quantify potential conflicts of interest (CoIs) in pediatric medical journals, specifically examining sex differences. To identify potential CoIs, we examined manuscripts published prior to 2019 in six pediatric journals (JAMA Pediatrics, Pediatrics, The Journal of Pediatrics, Pediatric Blood and Cancer, Pediatric Critical Care Medicine, and The Pediatric Infectious Disease Journal). We collected physician demographics and specialty from the National Plan and Provider Enumeration System National Provider Identifier Registry and compensation data from both ProPublicas Dollars for Docs (PDD) and Centers for Medicare and Medicaid Services Open Payments (CMSOP). Data was collected on 2,747 authors from 929 manuscripts. Of the 1,088 authors based in the United States with medical degrees (40.5% female), 510 (46.9%) had entries in PDD and CMSOP. Overall, 11,791 payments to these physician-authors totaled $9,586,089.97. Males were 19.6% more likely to receive payments (RR = 1.20, 95% CI [1.05, 1.37], p = 0.008). The mean amount received by males was $23,250.71 while that received by females was $10,970.78 (mean difference = 12,279.92, 95% CI = (2036.31, 22,523.54), p = 0.019). A comprehensive understanding of these CoIs can inform the disclosure policies of journals to promote transparency of authors.