A novel approach to assess minimally invasive surgical device failure utilizing adverse event outcome severity and design complexity.

Medical device failure and misuse have the potential to cause serious injury and death. Given the intricate nature of the instruments utilized specifically in minimally invasive surgery (MIS), users and manufacturers of surgical devices share a responsibility in preventing user error and device failure. A novel approach was presented for the evaluation of minimally invasive device failures, which involved assessing the severity of adverse event outcomes associated with the failures modes and investigating aspects of the devices’ design that may contribute to failure. The goals of this research were to 1) characterize the design attributes, failure modes, and adverse events associated with minimally invasive surgical devices and 2) describe the relationship between minimally invasive surgical device design complexity and the severity of adverse events. The types of failure modes, phases of operation in which failure occurs, severity of adverse event outcomes, and design complexity associated with four minimally invasive surgical devices were determined. An association was shown to exist between phases of surgical device operation and the severity of outcomes that occur in each phase (p \u3c 0.05). Across both device types, the majority of failure occurred during execution of the devices’ main function which involved securing and transecting tissue. The least amount of failures occurred during the results and post-op phase of operation; however, the failures that occurred during this phase resulted in the highest average outcome severity. The endoscopic staplers assessed resulted in overall higher average outcome severities relative to that of the tissue sealers. The methods employed are the first to evaluate medical device design, function, and failure outcomes from a complexity perspective. While statistical conclusions regarding the overall research goal could not be drawn, heuristic methods support development of the approach presented. The work herein assists the enhancement of risk awareness and prevention techniques and serves as a contribution to filling the knowledge gap regarding device use and failure outcomes. Bridging the gap between surgeons and engineers is crucial to the successful implementation and evaluation of new technology in the operating room, which was an essential component of this research

Analyzing Adverse Events from Publicly Available Web Sources

Data mining for drug-reaction associations is a major topic in the pharmaceutical industry. Historically the focus has been on using privately owned and maintained datasets consisting of information that has been transformed via the FDA Adverse Event Reporting System (FAERS) and privatized reporting systems that house the data from clinical trials. Our focus will be on building a pipeline that demonstrates an open source solution for building a drug’s safety profile from data collection through signal detection. In contrast this pipeline primarily uses the openFDA and social media data available through Reddit with all analysis being done in the R statistical programming language. The aim was to collect the information available in these public sources and apply popular data mining methodologies used to identify and predict the occurrence of adverse events. The results show the ability of the openFDA and social media sites to create real-time drug safety occurrence profiles by applying the same statistical methods applied in clinical trials. Social media will be shown to provide the best results when applied to prescribed daily use medications compared to common over-the-counter drugs or last line of defense medications. The information and results reported in this paper are not intended or implied to be a substitute for professional medical advice, diagnosis, or treatment. Do not delay seeking medical treatment or advice because of something you have read in this paper

Open source automated insulin delivery: addressing the challenge

Do-it-yourself automated insulin delivery systems for people living with type 1 diabetes use commercially available continuous glucose sensors and insulin pumps linked by unregulated open source software. Uptake of these systems is increasing, with growing evidence suggesting that positive glucose outcomes may be feasible. Increasing interest from people living with, or affected by, type 1 diabetes presents challenges to healthcare professionals, device manufacturers and regulators as the legal, governance and risk frameworks for such devices are not defined. We discuss the data, education, policy, technology and medicolegal obstacles to wider implementation of DIY systems and outline the next steps required for a co-ordinated approach to reducing variation in access to a technology that has potential to enable glucose self-management closer to target

New Product Development Processes for IOT-Enabled Home Use Medical Devices: A Systematic Review

Background: In the new forefront of healthcare at patients’ homes, medical devices developed to use at home setting by lay users are essential. The adoption of home-use medical devices will benefit both patients and public healthcare services in terms of quality of life, enhanced outcomes, and reduced cost of care. Home use medical devices associated with Internet-Of-Things (IOT) technology assists patients in performing self-care as well as providing health information remotely to health care professionals. However, adopting technology requires understanding the nature of the medical device and medical device development (MDD). Existing studies concerning the new product development (NPD) processes or design processes were systematically reviewed to explore knowledge and expertise to provide a framework for IOT engineers or designers to adopt IOT technology to home use medical devices. Objective: This study aimed to review the published literature to explore the current studies in the field of the NPD process, design process, design methodology, and outcome of the device affecting user acceptance. Methods: A systematic review following PRISMA guidelines of the English language literature from four electronic databases and academic search engines published from 2007 to 2018 was conducted. The papers were screened and assessed following predefined inclusive and exclusive criteria. The results were analyzed according to the research questions. Results: The findings revealed state-of-the-art in the NPD process and design process (n=4), the design methodology (n=23), and the resultant outcomes of empirical or clinical research in the validation stage (n=14) of medical device development (MDD). The findings also delineated existing studies in NPD, design process, and design methodologies aimed to ensure that medical devices would be effective and safe. Human factor engineering (HFE), cognitive method, ethnographic, and other methodologies were proposed to understand users, uses and context of use. Barriers, constraints, and multidisciplinary communication were addressed. Tools, processes, and methodologies were proposed to overcome the barriers. Conclusion: As home-use medical device development (MDD) and the adoption of IOT technology is now at a crossroads. This study addresses the necessity for future academic studies related to IOT adoption to MDD, including unique risks, multidisciplinary problems, emerging from IOT technology. Finally, future studies aimed at fabricating the NPD process or design process for IOT home-use medical devices to gain user acceptance were outlined

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines

Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles with those for medicines, identify potential gaps, and make recommendations for the adoption of new methodologies for the ongoing benefit–risk monitoring of these devices throughout their entire life cycle. A literature review served to examine the current tools for the safety evaluation of NAIMDs and those for medicines. We searched MEDLINE using these two categories. We supplemented this search with Google searches using the same key terms used in the MEDLINE search. Using a comparative approach, we summarized the new product design, development cycle (preclinical and clinical phases), and post-market phases for NAIMDs and drugs. We also evaluated and compared the respective processes to integrate and assess safety data during the life cycle of the products, including signal detection, signal management, and subsequent potential regulatory actions. The search identified a gap in NAIMD safety signal generation: no global program exists that collects and analyzes adverse events and product quality issues. Data sources in real-world settings, such as electronic health records, need to be effectively identified and explored as additional sources of safety information, particularly in some areas such as the EU and USA where there are plans to implement the unique device identifier (UDI). The UDI and other initiatives will enable more robust follow-up and assessment of long-term patient outcomes. The safety evaluation system for NAIMDs differs in many ways from those for drugs, but both systems face analogous challenges with respect to monitoring real-world usage. Certain features of the drug safety evaluation process could, if adopted and adapted for NAIMDs, lead to better and more systematic evaluations of the latter

Menstrual cup use, leakage, acceptability, safety, and availability: a systematic review and meta-analysis

Background Girls and women need effective, safe, and affordable menstrual products. Single-use products are regularly selected by agencies for resource-poor settings; the menstrual cup is a less known alternative. We reviewed international studies on menstrual cup leakage, acceptability, and safety and explored menstrual cup availability to inform programmes. Methods In this systematic review and meta-analysis, we searched PubMed, Cochrane Library, Web of Science, Popline, Cinahl, Global Health database, Emerald, Google Scholar, Science.gov, and WorldWideScience from database inception to May 14, 2019, for quantitative or qualitative studies published in English on experiences and leakage associated with menstrual cups, and adverse event reports. We also screened the Manufacturer and User Facility Device Experience database from the US Food and Drug Administration for events related to menstrual cups. To be eligible for inclusion, the material needed to have information on leakage, acceptability, or safety of menstrual cups. The main outcome of interest was menstrual blood leakage when using a menstrual cup. Safety outcomes of interest included serious adverse events; vaginal abrasions and effects on vaginal microflora; effects on the reproductive, digestive, or urinary tract; and safety in poor sanitary conditions. Findings were tabulated or combined by use of forest plots (random-effects meta-analysis). We also did preliminary estimates on costs and environmental savings potentially associated with cups. This systematic review is registered on PROSPERO, number CRD42016047845. Findings Of 436 records identified, 43 studies were eligible for analysis (3319 participants). Most studies reported on vaginal cups (27 [63%] vaginal cups, five [12%] cervical cups, and 11 [25%] mixed types of cups or unknown) and 15 were from low-income and middle-income countries. 22 studies were included in qualitative or quantitative syntheses, of which only three were of moderate-to-high quality. Four studies made a direct comparison between menstrual cups and usual products for the main outcome of leakage and reported leakage was similar or lower for menstrual cups than for disposable pads or tampons (n=293). In all qualitative studies, the adoption of the menstrual cup required a familiarisation phase over several menstrual cycles and peer support improved uptake (two studies in developing countries). In 13 studies, 73% (pooled estimate: n=1144; 95% CI 59–84, I2=96%) of participants wished to continue use of the menstrual cup at study completion. Use of the menstrual cup showed no adverse effects on the vaginal flora (four studies, 507 women). We identified five women who reported severe pain or vaginal wounds, six reports of allergies or rashes, nine of urinary tract complaints (three with hydronephrosis), and five of toxic shock syndrome after use of the menstrual cup. Dislodgement of an intrauterine device was reported in 13 women who used the menstrual cup (eight in case reports, and five in one study) between 1 week and 13 months of insertion of the intrauterine device. Professional assistance to aid removal of menstrual cup was reported among 47 cervical cup users and two vaginal cup users. We identified 199 brands of menstrual cup, and availability in 99 countries with prices ranging US$0·72–46·72 (median$23·3, 145 brands). Interpretation Our review indicates that menstrual cups are a safe option for menstruation management and are being used internationally. Good quality studies in this field are needed. Further studies are needed on cost-effectiveness and environmental effect comparing different menstrual products. Funding UK Medical Research Council, Department for International Development, and Wellcome Trust

LEARNING FROM INTERORGANIZATIONAL PRODUCT FAILURE EXPERIENCE IN THE MEDICAL DEVICE INDUSTRY

Much research examines the causes of product failures such as the Ford Pinto gas tank design. Research also examines the consequences of product failures such as new product introductions resulting from the need to improve failed products. However, little is known about how the causes and consequences of product failures interact across different firms, and generate inter-organizational learning, within the same industry. Specifically, limited research has examined if a firm learns to reduce its own annual rate of product failures (e.g., experiences fewer product-related adverse events) by attending to the product failures and new product introductions of its competitors. In addition, we also do not know (1) how delayed reporting of product failure influences interorganizational learning, and (2) how the introduction of new products by one company impacts another firm’s effort to learn from this competitor’s product failures. To address these gaps, this dissertation develops and tests relationships between (1) inter-organizational learning from product failures, (2) product failure reporting delays, and (3) new product introductions. Regression analysis of 98,576 manufacturing firm-year observations from the medical device industry over a ten-year period (1998 to 2008) supports the proposed model. Specifically, the analysis supported two insights: (1) As expected, a competitor’s reporting delays can inhibit learning from others’ failures by increasing the chance of making poor inferences about the failure. Unexpectedly, however, delays can also improve inter-organizational learning because in reports that have taken longer to file, a clearer understanding of the failure’s cause-effect relationships is developed. iii (2) As expected, a competitor\u27s new product introductions positively impact interorganizational learning by transferring knowledge of product design between firms. Unexpectedly, a competitor’s new product introductions can also negatively impact inter-organizational learning from product failure by distracting the observing firm’s attention away from the competitor’s failures. The thesis contributes to the inter-organizational learning literature by: (1) modelling learning from others’ product failures, (2) highlighting the effects of reporting delays, and (3) showing how others’ new product introductions can distract. This thesis shows that learning from others’ product failures and new product introductions has significant benefits because it prevents serious injury and death among device users

Regulating Innovation with Uncertain Quality: Information, Risk, and Access in Medical Devices

We propose a model where new product quality is uncertain, but market participants learn over time. Regulation balances information\u27s role in reducing consumer risk versus reducing access to innovation. Using new data and variation between EU and US medical device regulations, we document patterns consistent with the model and estimate its parameters. We find: (1) without information from testing, risk would severely inhibit usage; (2) US policy maximizes total surplus in our estimated model while the EU could gain 20 percent with more pre-market testing; and (3) more “post- market surveillance” could increase surplus 24 percent

Strategies for Reducing Adverse Medical Events from Implanted Medical Devices

Managing medical device monitoring processes is challenging and lacks a realtime, life cycle tracking strategy to reduce adverse medical events and revision costs for hospital administrators, physicians, and patients. Understanding the malfunctions of medical devices for cardiac and orthopedic patients could save lives and reduce hospital liability. Grounded in the business process reengineering conceptual framework, the purpose of this single qualitative case study was to explore strategies hospital managers used to redesign the implant recall surveillance process at one hospital in Pennsylvania. The 5 participants selected successfully implemented a medical device surveillance process that reduced adverse medical events and revision costs. Data were collected using semistructured interviews and a review of relevant medical device surveillance workflow documents. The 4 themes that emerged from a thematic analysis were effective data communication process, central data repository integration, continuous process improvement, and end-to-end surveillance process. A key recommendation for hospital administrators, physicians, and managers is to use blockchain distributed ledger technology to assess device identification challenges as part of the surveillance process to reduce health risks. The implication for positive social change includes the potential to improve the quality of life for medical device recipients who may spend less on healthcare services