Using Zigbee to Integrate Medical Devices

Medical devices are manifold and one of the most innovative fields of technology. As technologies advance, former limits cease to exist and complex devices become reality. Medical devices represent a very dynamic field with high economic relevance. The manufacturer of a medical device is obliged to minimize product-related risks as well as to demonstrate compliance with the so-called "essential requirements" regarding safety and performance before placing the device on the market. Any critical incident in relation to the application of a medical device has to be reported to the competent authority for risk assessment, which in Germany is either the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute (PEI) depending on the type of device. In this article, the German regulatory framework for medical devices and the resulting tasks for BfArM are described as well as the topics of its recently installed research and development group on prospective risk identification and application safety for medical devices. Results of failure mode and root cause analyses of incident data are presented as well as further data on cases with the result "root-cause analysis not possible". Finally an outlook is given on future challenges regarding risk assessment for medical devices.

Purpose: This study aimed to investigate the clinical alarm occurrence and management of nurses toward clinical alarms in the intensive care unit (ICU). Methods: This observational study was conducted with 40 patients and nurses cases in two ICUs of a university hospital. This study divided 24 hours into the unit of an hour and conducted two times of direct observation per unit hour for 48 hours targeting the medical devices applied to 40 patients. Data were analyzed using IBM SPSS Statistics 23. Results: On average, 3.8 units of medical devices were applied for each patient and the ranges of alarm settings were wide. During 48 hours, 184 cases of clinical alarm were occurred by four types of medical devices including physiological monitors, mechanical ventilators, infusion pumps, and continuous renal replacement therapy. Among them, false alarm was 110 cases (59.8%). As for the alarm management by ICU nurses, two-minute alarm mute took up most at 38.0% (70 cases), and no response was second most at 32.6% (60 cases). When valid alarm sounded, nurses showed no response at 43.2%. Conclusion: The findings suggest that a standard protocol for alarm management should be developed for Korean ICU settings. Based on the protocol, continuous training and education should be provided to nurses for appropriate alarm management. Key Words: Clinical alarm; Intensive care unit; Medical device; Observation Key Words: 경보음; 중환자실; 의료장비; 관찰

Many accidents happen daily in different technological areas, and a great proportion of these accidents are due to human errors. Many of these incidents may be a consequence of flaws in the equipment software interface, which can be accountable for user’s’ errors. Touchscreen technology is more and more a part of everyday life in all types of devices, such as medical devices, for example. This methodology aims to determine the items presented in the form of a checklist to ensure that a medical device can actually incorporate touchscreen technology. The use of touchscreen technology in medical devices can be assessed on three different fronts: human factor engineering (HFE), manufacturers, and user experience. This essay is an initial study yet is extremely important to guide manufacturers about touchscreen technology usage not only on the devices already available in the market but also on new products to be launched in the future.

Moderate-risk medical devices constitute 99% of those that have been regulated by the U.S. Food and Drug Administration (FDA) since it gained authority to regulate medical technology nearly five decades ago. This article presents an analysis of the interaction between the 510(k) process —the historically dominant path to market for most medical devices— and the De Novo pathway, a more recent alternative that targets more novel devices, including those involving new technologies, diagnostics, hardware, and software. The De Novo pathway holds significant potential for innovators seeking to define new categories of medical devices, as it represents a less burdensome approach than would have otherwise been needed historically. Moreover, it supports the FDA in its effort to modernize the long-established 510(k) pathway by promoting the availability of up-to-date device “predicates” upon which subsequent device applications can be based, reflecting positive spillovers that are likely to encourage manufacturers to adopt current state-of-the-art technologies and modern standards of safety and effectiveness. We analyze the of characteristics all the De Novo classification requests to date, including the submission type, trends, FDA review times, and device types. After characterizing how the De Novo process has been used over time, we discuss its unique challenges and opportunities with respect to medical device software and AI-enabled devices, including considerations for intellectual property, innovation, and competition economics.

<span lang="EN">Controlling the supply of disposable medical devices at RSUD Dr. Pringadi not completely running well. The purpose of this research is to control the supply of disposable medical devices in order to determine the amount optimal ordering and to find out the number of reorders on all types of disposable medical devices. In this research also did calculating the value of the investment in each type. Calculation results for the investment level group of 0-70% has 11 types of disposable medical devices with a financial value of IDR 64,136,040.00 or 70% of the total investment with Economic Order Quantity can be ordered from a total of 14-152 items, Buffer Stock or safety stock starts stocking from 1-198 items and Reorders Points range from 1-318 items. For the investment level group 71-90% have 21 types of disposable medical devices with a financial value of Rp 181,953,529.00 or 20% of the total investment with EOQ can be ordered from quantity 2-21237item, buffer stock from 2-1237item and ROP from reordered 4-1987item.</span><span lang="EN">For the investment level group of 91-100% has 71 types of disposable medical devices with a financial value of Rp 85,103,749.00 or 9.4% of the total investment with EOQ calculations ordered starting from 1-421, buffer stock starting from 2-247 items and ROP starting from 2 - 397items.So this research is useful to help the warehouse Pharmacist at RSUD Dr. Pringadi in controlling the supply of medical devices disposable.</span>

The objective of this work was to develop a wireless electrocardiogram (ECG) and acceleration detector powered by an imbedded battery. The module has a connector for a three-lead ECG socket and an embedded three-axis accelerometer. It also has an a secure digital (SD) memory slot and can store all data with 2 GB memory. The system transmits the data using a wireless module to measure ECG and an activity transition value. Using the correlation between accelerometer signal and ECG signal, the system can determine the activity assessment precisely and also detect cardiovascular abnormality.

A structured method to achieve cognitive depth for medical device use error topic modeling

Security in health-care information systems—current trends

Healthcare Technology Is on the Move

Stimulated by regulations and standards as well as commercial imperatives, medical device manufacturers are striving to make medical devices safer by decreasing the potential for harmful use errors. Accordingly, manufacturers are observing and interviewing intended users about their interactions with devices en route to developing user interface requirements; applying human factors engineering (HFE) principles when designing user interfaces; and conducting formative and summative usability tests to improve and validate their devices’ interactive quality. This has represented significant work for manufacturers, particularly the majority who started with little HFE knowledge and experience. Today, the “awakening” to HFE in medical device development is essentially over—an established manufacturer who is just now discovering HFE has been out of touch. After all, the U.S. Food and Drug Administration (FDA) and AAMI conducted their first joint conference on HFE in 1995 when they previewed HFE expectations related to recent changes in quality system regulation (QSR). So, it has been 17 years since HFE entered the medical industry’s zeitgeist. HFE specialists working in the medical industry used to focus on making devices more usable (i.e., user friendly). Since the QSR change, use safety has become the primary focus, resulting in user interfaces that are less vulnerable to harmful use errors. It is rather obvious how HFE affects the safety of some medical devices. In the design of a surgical instrument, for example, HFE’s aim would be to reduce the chance of cutting anything other than the intended target. This goal could be accomplished by including a blade guard and a mechanical interlock that requires more than one deliberate action to enable cutting.

BackgroundIncreased life expectancy and the accompanying prevalence of chronic conditions have led to the focus and delivery of health care migrating from the hospital and into people’s homes. While previous studies have investigated the integration of particular types of medical devices into the home, it was our intention to describe how medical devices are integrated into the lives of older people.MethodsAdopting a qualitative study design, 12 older people, who used medical devices in the home, took part in in-depth, semi structured interviews. In 7 of the interviews participants and their partners were interviewed together. These interviews were recorded, transcribed and analysed thematically.ResultsTwo themes were constructed that describe how medical devices that are used in the home present certain challenges to older people and their partners in how the device is adopted and the personal adaptations that they are required to make. The first theme of 'self-esteem’ highlighted the psychological impact on users. The second theme of 'the social device' illustrated the social impact of these devices on the user and the people around them.ConclusionsWe found that these devices had both a positive and negative psychosocial impact on users’ lives. An improved understanding of these psychological and social issues may assist both designers of medical devices and the professionals who issue them to better facilitate the integration of medical devices into the homes and lives of older people.

As Artificial Intelligence (AI) advances, it is included into more and more medical device systems to carry out these systems’ intended functions. Given AI’s ability to learn from real-world use and its capability to continuously improve performance, manufacturers of medical devices are utilizing AI to innovate their products to better assist health care providers. However, like application of other types of medical devices, the application of AI in medical care might pose different types of potential risks to the patients, the users themselves, and to the use environment. For manufactures to successfully ensure the safety of AI medical devices, it is crucial to identify known problems by investigating use-related, user interface, and user interaction in-cidents that have occurred in comparable medical devices. The objective of this study is to identify potential use-related problems of DeepView® Wound Imaging System that assesses the healing potential of thermal burn wounds by analyzing multispectral images with an ML algorithm. We use a variety of sources of information on reports and recalls of medical devices that are associated with deaths, serious injuries and mal-functions. After examining relevant reports and recalls, 19 use-related problems were identified. An in-depth analysis was then conducted, considering each identified use-related problem and determining how it relates to the specific features and functionality of DeepView® Wound Imaging System as well as identifying patterns and commonalities among them. The information gained from this analysis can be beneficial in enhancing the safety of AI medical devices by providing a deeper understanding of the reasons for failure, to avoid similar issues in the future, and ultimately to improve patient safety and public health.

Medical prototyping using two photon polymerization

Background and Objective: Medical devices (MDs) play a pivotal role in the modern healthcare environment. Adverse events are an expected part of an MD’s lifecycle. To prevent the recurrence of such events, various vigilance systems have been established worldwide. The Manufacturer and User facility Device Experience (MAUDE) database of the US Food and Drug Administration (FDA) is a publicly accessible database that contains data of medical device reports (MDRs) submitted to FDA since 1991. The aim of this study is to examine the evolution of MD adverse event reports and analyze several characteristic parameters, as they evolved during the last three decades. Material and Methods: An analysis of MAUDE data was performed to examine the outcomes and device characteristics of adverse event reports from 1991 up to 11/2022. These outcomes included the event type, remedial action, report source, reporter occupation and device evaluation by manufacturer. Specific MD groups were analyzed separately to examine their effect on the event outcomes. Segregated files of the database that contain different types of information on adverse event reports were combined to investigate the various aspects of these reports. Results: Event outcomes are presented as annual histograms. An overall of about 15 million reports have been submitted to MAUDE during the 30 years period examined with more than 2.5 million of them during the first 10 months of the year 2022. This number is growing at an increasing rate. Most of the events (63.5%) have resulted in simple device malfunction, without serious implications to the patient. Depending on the device type however, the health risks may be higher (98.4% injuries from specific dental implants and 3.2% deaths from implantable defibrillators). About 20% of the reports have led to recalls or other corrective actions. Most of the reports (96%) are submitted by manufacturers and over 70% of the devices returned to them are evaluated, following the requirements of FDA 21 CFR, 803. The reporter’s occupation was found to be related to the types of devices associated with the event. Finally, the average device age was found to be 4 years, with an increasing tendency observed over the years, while still most of the events occur during the first year of operation. Conclusion: A medical device adverse event reporting system is a critical component of safety in the use of medical technology in modern healthcare. The information available in MAUDE and its use continues to grow at an accelerated rate and allows critical improvements of MDs, especially in terms of risk prevention, as it gives perception about their safety issues. FDA has taken various steps to encourage and facilitate adverse event reporting and make the data available to the public.

This paper describes the methodology for rapid prototyping of nitinol structures by heat setting. Nitinol is a shape memory alloy commonly used in implantable medical devices. The proposed technique, based on 3D printing, can be used to effectively iterate multiple nitinol designs for different types of medical devices. We describe a rapid and low-cost process of ceramic replica molding of standard 3D printed parts to create high-temperature resistant fixtures, suitable for heat setting of nitinol. The technique represents a low cost (<$20 materials per fixture) and rapid (as quickly as 16 h for a volume less than 1.25 × 105 mm3) method for shaping nitinol, a technique that typically is costly, labor intensive, and requires specialized equipment. Our method satisfies a need for cost-effective, rapid prototyping of nitinol for implantable medical devices, and we show an example set of shaped nitinol wires, clips, and stents. This method is straightforward and can be easily applied by researchers to rapidly iterate medical device designs.