Biomedical Instrumentation and Technology最新文献

When approaching an ethylene oxide (EO) sterilization validation, medical device manufacturers traditionally have two choices. They can use biological indicators (BIs) to monitor each production run or establish a parametric release process in which sterile release is based on the monitoring and control of physical process parameters that ensure process specifications are met. In ISO 11135:2014, parametric release was brought to the forefront as an acceptable release method; however, a perception exists that implementing parametric release is challenging and time consuming. This article will demonstrate that the opposite is true. It presents a streamlined approach in which parametric release is addressed through the various stages of validation: product definition, process definition, performance qualification, routine release, and process control. Considerations for establishing specifications directly from validation versus "run and record" and trending critical process parameters (e.g., relative humidity, temperature, EO concentration) are discussed. In addition, the benefits of parametric release (active monitoring) over BI release (passive monitoring), including improvements to turnaround time, process control, risk mitigation, reduction of resource investment, and elimination of microbiological release testing, are highlighted. With multiple benefits, parametric release should be the gold standard for EO sterilization processes. It is not novel and has been widely accepted by regulatory agencies globally and notified bodies. The article further describes how the data collection and process capability that is central to process control and parametric release is more powerful than the information provided by a BI, which is merely a catastrophic indicator when used in routine processing.

Background: Continuous physiologic monitoring commonly is used in pediatric medical-surgical (med-surg) units and is associated with high alarm burden for clinicians. Characteristics of pediatric patients generating high rates of alarms on med-surg units are not known. Objective: To describe the demographic and clinical characteristics of pediatric med-surg patients associated with high rates of clinical alarms. Methods: We conducted a cross-sectional, single-site, retrospective study using existing clinical and alarm data from a children's hospital. Continuously monitored patients from med-surg units who had available alarm data were included. Negative binomial regression models were used to test the association between patient characteristics and the rate of clinical alarms per continuously monitored hour. Results: Our final sample consisted of 1,569 patients with a total of 38,501 continuously monitored hours generating 265,432 clinical alarms. Peripheral oxygen saturation (SpO₂) low alarms accounted for 57.5% of alarms. Patients with medical complexity averaged 11% fewer alarms per hour than those without medical complexity (P < 0.01). Patients older than 5 years had up to 30% fewer alarms per hour than those who were younger than 5 years (P < 0.01). Patients using supplemental oxygen averaged 39% more alarms per hour compared with patients who had no supplemental oxygen use (P < 0.01). Patients at high risk for deterioration averaged 19% more alarms per hour than patients who were not high risk (P = 0.01). Conclusion: SpO₂ alarms were the most common type of alarm in this study. The results highlight patient populations in pediatric medical-surgical units that may be high yield for interventions to reduce alarms. Most physiologic monitor alarms in pediatric medical-surgical (med-surg) units are not informative and likely could be safely eliminated to reduce noise and alarm fatigue.^1-3 However, identifying and sustaining successful alarm-reduction strategies is a challenge. Research shows that 25% of patients in pediatric med-surg units produce almost three-quarters of all alarms.⁴ These patients are a potential high-yield target for alarm-reduction strategies; however, we are not aware of studies describing characteristics of pediatric patients generating high rates of alarms. The patient populations seen on pediatric med-surg units are diverse. Children of all ages are cared for on these units, with diagnoses ranging from acute respiratory infections, to management of chronic conditions, and to psychiatric conditions. Not all patients on pediatric med-surg units have physiologic parameters continuously monitored,⁴ but among those who do, understanding patient characteristics associated with high rates of alarms may help clinicians, healthcare technology managemen

The publication of ISO 4135, Anaesthetic and respiratory equipment-Vocabulary, fourth edition, highlights expansion of the scope of the International Organization for Standardization (ISO) Technical Committee (TC) 121 and its Subcommittees and Working Groups during two decades of work. This document stands alongside ISO 19223:2019, Lung ventilators and related equipment-Vocabulary and semantics, to promote consistency and specificity of terminology across ISO/TC 121 standards.

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.