Safety Of Medical Devices Research Articles

Safety of handling of medical devices at all stages of their life cycle

The review describes the main points of the life cycle of a medical device, considers three stages of regulation of medical devices: pre-market, market and post-sale. The main attention is paid to post-sale supervision, as an activity for monitoring used medical devices, collecting information about the quality, safety and effectiveness of medical devices.

The Meat of the Matter: Understanding and Managing Alpha-Gal Syndrome.

Alpha-gal syndrome is an unconventional food allergy, characterized by IgE-mediated hypersensitivity responses to the glycan galactose-alpha-1,3-galactose (alpha-gal) and not to a food-protein. In this review, we discuss how alpha-gal syndrome reframes our current conception of the mechanisms of pathogenesis of food allergy. The development of alpha-gal IgE is associated with tick bites though the possibility of other parasites promoting sensitization to alpha-gal remains. We review the immune cell populations involved in the sensitization and effector phases of alpha-gal syndrome and describe the current understanding of why allergic responses to ingested alpha-gal can be delayed by several hours. We review the foundation of management in alpha-gal syndrome, namely avoidance, but also discuss the use of antihistamines, mast cell stabilizers, and the emerging role of complementary and alternative therapies, biological products, and oral immunotherapy in the management of this condition. Alpha-gal syndrome influences the safety and tolerability of medications and medical devices containing or derived from mammalian products and impacts quality of life well beyond food choices.

Tension-Free Vaginal Tape and Polyacrylamide Hydrogel Injection for Primary Stress Urinary Incontinence: 3-Year Followup from a Randomized Clinical Trial.

We sought to determine whether polyacrylamide hydrogel (PAHG) is noninferior to tension-free vaginal tape (TVT) in the treatment of women with primary stress urinary incontinence (SUI). In this noninferiority trial, 223 women eligible for operative SUI treatment were randomized for TVT (110) or PAHG (113). Primary outcome was patient satisfaction and the noninferiority margin for the difference was 20%. Secondary outcomes were effectiveness and complications. At 3 years, 188 (84.3%) women attended the followup. The satisfaction score (visual analogue scale 0-100) median was 98.5 (IQR 90-100) in the TVT group and 90.0 (IQR 70-100) in the PAHG group, whereas a score ≥80 was reached in 87 (94.6%) and 65 (67.7%), respectively (difference 26.9%, 95% CI 16.7% to 36.8%). Thus, PAHG did not meet the noninferiority criteria set in our study. The cough stress test was negative in 88 (95.7%) of TVT patients vs 75 (78.1%) of PAHG patients (difference 17.5%, 95% CI 8.6% to 26.9%). Any peri- or postoperative complication before crossover between the groups was detected in 40 (43.5%) women in the TVT group and 23 (24.0%) women in the PAHG group (difference 19.5%, 95% CI 6.8% to 31.4%). In midterm followup, PAHG did not reach in patient satisfaction the noninferiority set in our study. Furthermore, mid urethral TVT slings show better subjective and objective cure rates than PAHG. However, complications were more often associated with TVT. Since the majority of PAHG treated women were also cured or improved, primary SUI women can be offered PAHG as a safe and durable alternative treatment.

Safety and Effectiveness of a Catheter With Contact Force and 6-Hole Irrigation for Ablation of Persistent Atrial Fibrillation in Routine Clinical Practice

The ThermoCool SmartTouch catheter (ablation catheter with contact force and 6-hole irrigation [CF-I6]) is approved by the US Food and Drug Administration (FDA) for paroxysmal atrial fibrillation (AF) ablation and used in routine clinical practice for persistent AF ablation, although clinical outcomes for this indication are unknown. There is a need to understand whether data from routine clinical practice can be used to conduct regulatory-grade evaluations and support label expansions. To use health system data to compare the safety and effectiveness of the CF-I6 catheter for persistent AF ablation with the ThermoCool SmartTouch SurroundFlow catheter (ablation catheter with contact force and 56-hole irrigation [CF-I56]), which is approved by the FDA for this indication. This retrospective, comparative-effectiveness cohort study included patients undergoing catheter ablation for persistent AF at Mercy Health or Mayo Clinic from January 1, 2014, to April 30, 2021, with up to a 1-year follow-up using electronic health record data. Use of the CF-I6 or CF-I56 catheter. The primary safety outcome was a composite of death, thromboembolic events, and procedural complications within 7 to 90 days. The exploratory effectiveness outcome was a composite of AF-related hospitalization events after a 90-day blanking period. Propensity score weighting was used to balance baseline covariates. Risk differences were estimated between catheter groups and averaged across the 2 health care systems, testing for noninferiority of the CF-I6 vs the CF-I56 catheter with respect to the safety outcome using 2-sided 90% CIs. Overall, 1450 patients (1034 [71.3%] male; 1397 [96.3%] White) underwent catheter ablation for persistent AF, including 949 at Mercy Health (186 CF-I6 and 763 CF-I56; mean [SD] age, 64.9 [9.2] years) and 501 at Mayo Clinic (337 CF-I6 and 164 CF-I56; mean [SD] age, 63.7 [9.5] years). A total of 798 (55.0%) had been treated with class I or III antiarrhythmic drugs before ablation. The safety outcome (CF-I6 - CF-I56) was similar at both Mercy Health (1.3%; 90% CI, -2.1% to 4.6%) and Mayo Clinic (-3.8%; 90% CI, -11.4% to 3.7%); the mean difference was noninferior, with a mean of 0.5% (90% CI, -2.6% to 3.5%; P < .001). The effectiveness was similar at 12 months between the 2 catheter groups (mean risk difference, -1.8%; 90% CI, -7.3% to 3.7%). In this cohort study, the CF-I6 catheter met the prespecified noninferiority safety criterion for persistent AF ablation compared with the CF-I56 catheter, and effectiveness was similar. This study demonstrates the ability of electronic health care system data to enable safety and effectiveness evaluations of medical devices.

SENTINEL SYSTEM – electronic system for collecting real-world data

The need to use more and more data to generate evidence in response to new challenges in clinical medicine requires a specific response from the healthcare system. The high pace of development of medicine, the acceleration of the development of new drugs in response to the increasing needs of clinicians for treating patients leads to the need for a rapid assessment of treatment outcomes, efficacy and safety of new drugs. The development of a tool for centralized collection of data on efficacy and safety, capable of connecting as many clinical centers as possible: hospitals, private medical centers, scientific institutions — is a priority for the health system to implement these responses. An example of this type of data collection and analysis coordination system development is the 2007 Food a nd Drug Administration (FDA) Sentinel initiative.Sentinel is a national electronic system that has changed the way researchers monitor the safety of FDA-regulated medical products, including drugs, vaccines, biologics, and medical devices. Monitoring the safety of regulated products is an important part of the FDA»s mission to protect public health.This review is devoted to the history of development, organizational structure, principles of operation and demonstration of some projects of the Sentinel system. The review will consider both projects developed for application within the framework of general clinical problems (use in vulnerable groups of patients, patients with kidney diseases, etc.), and projects developed in response to the needs of researchers that have arisen in the era of the COVID-19 pandemic.

Cleaning Quality Control Management of Medical Equipment in Hospital Disinfection Supply Room Based on Smart Medicine.

With the continuous improvement of medical level, the demand for medical devices increases year by year, and it is necessary to track the quality and safety of medical devices. Establishing the cleaning quality control management of medical devices can not only reduce medical accidents and inhibit the spread of counterfeit or substandard medical devices but also help enterprises find the source of problems, determine the flow of the same batch of products, and warn relevant enterprises to take measures after the occurrence of problem products, and ultimately ensure the rights and interests of consumers. This study aims to study the cleaning quality control management of medical equipment in the hospital disinfection supply room based on smart medical care and proposes related concepts of smart medical care, as well as related theories of Internet of Things technology and medical equipment tracking system and related concepts of medical equipment cleaning. In this study, by comparing the cleaning compliance rates of the two groups of medical devices through smart medical care, it can be seen that 100% of the research group applying program-based management is significantly higher than 76.6% of the conventional management path. There was statistical significance in the data comparison between groups (P < 0.05). Therefore, programmatic management is more targeted than conventional management paths.

Abstract P1123: Establishment Of An In Vitro Method To Evaluate Chronic Cardiac Contractility Modulation Signals In 3d Human Engineered Cardiac Tissues

Background: Cardiac contractility modulation (CCM) is a medical device-based therapy delivering non-excitatory electrical simulations to the heart during the absolute refractory period to enhance cardiac function. We previously evaluated the acute effects of CCM in isolated rabbit-CM and 2D hiPSC-CM monolayers, on flexible substrate, and found enhanced calcium and contractility. In the present study, we sought to extend these results to chronic studies in 3D human engineered cardiac tissues (ECTs) to develop a robust model to evaluate the long-term effects of CCM stimulation in vitro on intact human cardiac tissues. Methods: HiPSC-CMs and cardiac fibroblasts in a fibrin-based gel were combined to form ECTs (Figure 1). Morphology and contractility were evaluated. We found ECTs displayed baseline peak contraction amplitude of 194.8±80.8 a.u., (n=5) and peak force and stress of 26.5±6.8 uN, (n=5) and 87.9±22.0.8 Pa, (n=5) respectively. ECT displayed robust baseline electrophysiological (AP) properties and calcium handling properties. Chronic CCM pulses (i.e., 30 minutes) were applied using a commercial pulse generator. Under these conditions ECTs displayed enhanced contractile kinetics 29.0±0.04 %, (P&lt;0.01, n=4), relaxation kinetics 23.0±0.05 %, (P&lt;0.05, n=4), and shorter duration 32.0±0.03 %, (P&lt;0.01, n=4) relative to time matched control. Conclusion: This study provides a comprehensive characterization of chronic CCM effects on 3D ECTs. Future studies will investigate prolonged time points. These data provide an in vitro model to assess physiologically relevant mechanisms and evaluate safety and efficacy of future cardiac electrophysiology medical devices. Disclaimer: The mention of commercial products, their sources, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by the Department of Health and Human Services.

PreS/MD: Predictor of Sensitization Hazard for Chemical Substances Released From Medical Devices.

In the United States, a pre-market regulatory submission for any medical device that comes into contact with either a patient or the clinical practitioner must include an adequate toxicity evaluation of chemical substances that can be released from the device during its intended use. These substances, also referred to as extractables and leachables, must be evaluated for their potential to induce sensitization/allergenicity, which traditionally has been done in animal assays such as the guinea pig maximization test (GPMT). However, advances in basic and applied science are continuously presenting opportunities to employ new approach methodologies, including computational methods which, when qualified, could replace animal testing methods to support regulatory submissions. Herein, we developed a new computational tool for rapid and accurate prediction of the GPMT outcome that we have named PreS/MD (predictor of sensitization for medical devices). To enable model development, we (1) collected, curated, and integrated the largest publicly available dataset for GPMT results; (2) succeeded in developing externally predictive (balanced accuracy of 70%-74% as evaluated by both 5-fold external cross-validation and testing of novel compounds) quantitative structure-activity relationships (QSAR) models for GPMT using machine learning algorithms, including deep learning; and (3) developed a publicly accessible web portal integrating PreS/MD models that can predict GPMT outcomes for any molecule of interest. We expect that PreS/MD will be used by both industry and regulatory scientists in medical device safety assessments and help replace, reduce, or refine the use of animals in toxicity testing. PreS/MD is freely available at https://presmd.mml.unc.edu/.

Evaluation of the safety of paclitaxel eluting medical devices to treat peripheral arterial disease – The DETECT “Drug EluTing dEvices FrenCh safeTy survey” national study

A meta-analysis published in 2018 concluded that mid-term and long-term mortality was higher in patients treated with paclitaxel eluting balloons and stents than in those treated with bare devices after the endovascular treatment of femoropopliteal lesions. There are no national data concerning the safety of these devices. We designed the DETECT (Drug EluTing dEvices FrenCh safeTy survey) study in order to compare the risk of mortality in patients treated with paclitaxel eluting balloons and/or stents or with bare devices.

Actual Class Contents Related to the Drug and Medical Device Safety Information Reporting System in Medical Schools across Japan

Actual Class Contents Related to the Drug and Medical Device Safety Information Reporting System in Medical Schools across Japan

Study on the Medical Device Registration Submission Dossier Requirements in China

The evolution throughout the whole supervision history of Class II/III safety and effectiveness related NMPA submission dossier requirements was studied in this study, meanwhile elaborating the revolution progress of clinical evaluation domestically. The relationship between submission dossier requirements and Essential Principles of Safety and Performance of Medical Devices as well as IMDRF relevant documents was deeply analyzed and illustrated, in order to comprehensively understanding the background and future reform direction of NMPA submission dossier requirements under the background of the government's deepening reform of medical device evaluation and approval system strategy.

Case Series

Health technology managers play a vital role in medical device safety for pediatric patients in the neonatal intensive care unit and the pediatric intensive care unit. Medical device malfunctions and failures can contribute to potential for harm and adverse events. These patients are especially vulnerable to harm when these incidents occur. When health technology managers provide their expertise on medical device malfunction reports, their valuable input can provide a more complete view of the safety concerns to the US Food and Drug Administration and the device manufacturer. The examples in this article are from medical device reports submitted to the US Food and Drug Administration's MedSun program and illustrate how health technology managers' input has advanced US Food and Drug Administration's understanding of medical device safety concerns and contributed to subsequent recalls and other safety actions for devices used in the neonatal intensive care unit and pediatric intensive care unit.

Voting behavior during FDA Medical Device Advisory Committee panel meetings.

ObjectivesDuring premarket review, the US Food and Drug Administration may ask its Medical Device Advisory Committee (MDAC) Panels to assess the safety and effectiveness of medical devices being considered for approval. The objective of this study is to assess the relationship, if any, between individual votes and Panel recommendations and: (1) the composition of Panels, specifically the expertise and demographic features of individual members; or (2) Panel members’ propensity to speak during Panel deliberations.MethodsThis was a retrospective cohort study of routinely collected data from voting members of MDAC panels convened between January 2011 to June 2016 to consider premarket approval. Data sources were verbatim transcripts available publicly from the FDA. Number of words spoken, directionality of votes on device approval, profession, and demographics were collected.Results658,954 words spoken by 536 members during 49 meetings of 11 Panels were analyzed. Based on multivariate analysis, biostatisticians spoke more (+373 words; P = 0.0002), and women (-187 words; P = 0.0184) and other non-physician voting members less (-213 words; P = 0.0306), than physicians. Speaking more was associated with abstaining (P = 0.0179), and with voting against the majority (P = 0.0153). Non-physician, non-biostatistician members (P = 0.0109), and those having attended more meetings as a voting member (P = 0.0249) were more likely to vote against approval. In bivariable analysis, unanimous Panels had a greater proportion of biostatisticians (mean 0.1580; 95% CI 0.1237–0.1923) than non-unanimous Panels (0.1107; 95% CI 0.0912–0.1301; p = 0.0201).ConclusionsPanelists likely to vote against the majority include non-physician, non-biostatisticians; experienced Panelists; and more talkative members. The increased presence of biostatisticians on Panels leads to greater voting consensus. Having a diversity of opinions on Panels, including in sufficient numbers those members likely to dissent from majority views, may help ensure that a diversity of opinions are aired before decision-making.

Scientific and Regulatory Policy Committee Points to Consider for Medical Device Implant Site Evaluation in Nonclinical Studies.

Nonclinical implantation studies are a common and often critical step for medical device safety assessment in the bench-to-market pathway. Nonclinical implanted medical devices or drug-device combination products require complex macroscopic and microscopic pathology evaluations due to the physical presence of the device itself and unique tissue responses to device materials. The Medical Device Implant Site Evaluation working group of the Society of Toxicologic Pathology's (STP) Scientific and Regulatory Policy Committee (SRPC) was tasked with reviewing scientific, technical, and regulatory considerations for these studies. Implant site evaluations require highly specialized methods and analytical schemes that should be designed on a case-by-case basis to address specific study objectives. Existing STP best practice recommendations can serve as a framework when performing nonclinical studies under Good Laboratory Practices and help mitigate limitations in standards and guidances for implant evaluations (e.g., those from the International Organization for Standardization [ISO], ASTM International). This article integrates standards referenced by sponsors and regulatory bodies with practical pathology evaluation methods for implantable medical devices and combination products. The goal is to ensure the maximum accuracy and scientific relevance of pathology data acquired during a medical device or combination drug-device implantation study.

Efficacy and Safety of an Antioxidant-Enriched Medical Device for Topical Use in Adults with Eczematous Dermatitis.

IntroductionEmollients reduce the severity of dermatitis-associated symptoms. Antioxidant supplementation may be helpful to control inflammatory processes and consequential skin damage. The clinical performance and safety of an emollient medical device for topical treatment enriched with antioxidant ingredients in adults with mild-to-moderate dermatitis is presented in this manuscript.MethodsWe performed a monocenter, open‐label, uncontrolled clinical trial. Participants applied the product twice a day for 28 days. No other medication or moisturizer was allowed. Changes in dermatitis severity were assessed at days 14 and 28 by study investigators. Subjects self-assessed pruritus, Dermatology Life Quality Index, and product satisfaction. At the end of the study, a global evaluation of the product was done both by patient-reported outcomes and investigators’ evaluations.ResultsForty subjects were enrolled in the study (mean age 35 years). Treatment success was achieved in 87.5% of subjects (p < 0.0001) after 28 days. Mean Investigator’s Global Assessment (IGA) and Eczema Area and Severity Index (EASI) scores decreased at days 14 and 28 (p < 0.0001). Subjects reported a reduction in pruritus severity and improvement of quality of life (p < 0.0001), along with satisfaction with the product. At the end of the study, skin condition improved in more than 90% of subjects. No safety issues were identified.ConclusionThe medical device studied for topical use in this clinical trial is considered safe and reduces pruritus in adults with atopic and contact dermatitis.

Analysis of Medical Device Reports Involving Ventilator-Related Incidents in a Clinical Setting

Continuous ventilators are a critical resource for the treatment and management of respiratory diseases, particularly in the midst of the COVID-19 pandemic. Healthcare technology management professionals (HTMs) are instrumental toward protecting the safety of patients by ensuring that ventilators and ventilator accessories (ventilator-related medical devices) remain functional during their lifetime. This article discusses a retrospective analysis on the failure modes described in ventilator-related medical device reports that were submitted to the US Food and Drug Administration Medical Product Safety Network (MedSun). In addition, the article also examines MedSun case studies, obtained from medical device reports, to provide HTMs with a comprehensive analysis of the lifecycle of a safety signal and how their input is essential to improve the safety and effectiveness of medical devices. Postmarket medical device surveillance in a constantly changing medical device ecosystem benefits from the first-hand knowledge that HTMs contribute to the cross-functional collaboration between the clinical community, medical device manufacturers, and the US Food and Drug Administration.

Engaging Early-Career Physicians in Medical Device Innovation and Entrepreneurship.

Engaging Early-Career Physicians in Medical Device Innovation and Entrepreneurship.

Recalls of Moderate- and High-Risk Otolaryngologic Devices Approved by the US Food and Drug Administration, 2003-2019.

The US Food and Drug Administration (FDA) regulates the marketing of medical devices based on the premarket approval (PMA) or 510(k) pathway. We investigated the relationship among the regulatory pathway of otolaryngologic devices, the number of recalls, and the recall characteristics. Retrospective cross-sectional analysis. Publicly available FDA databases. The FDA Ear, Nose, and Throat Devices Panel database was queried for 510(k) clearances and PMA approvals from 1976 to 2019. Device recalls from 2003 to 2019 were reviewed. Devices were then categorized by subspecialty, type, supporting evidence, and PMA supplement type. Logistic regression characterized the odds of recall for each device type and subspeciality. A total of 1061 (57.8%) 510(k) and 778 (42.3%) PMA device applications and modifications were approved. There were 120 (11.3%) recall events associated with 42 unique otolaryngologic devices cleared via the 510(k) pathway, as compared with 25 (3.2%) recall events for 5 unique PMA devices. 510(k) device approvals were more likely to be recalled than PMA device approvals (odds ratio, 3.67; 95% CI, 2.38-5.88; P < .0001). 510(k) surgical devices (odds ratio, 2.1; 95% CI, 1.1-4.4; P = .03) were more likely to be recalled than diagnostic devices. Devices designated for laryngology (70.0%) and general otolaryngology (25.0%) composed the majority of recalls. Otolaryngologic devices approved by the FDA via the 510(k) pathway exhibit a higher number of recalls than the PMA pathway. Given the balance between regulation and facilitating innovation, postmarket surveillance and ongoing regulatory improvements are critical to ensure optimal safety of medical devices.

The Cumberlege Report and the development of the UK mesh centre network

Very few clinical debates have been as emotionally charged as the transvaginal mesh debate. The public furore over its use led to an independent enquiry, the IMMDS Review (Independent Medicines and Medical Devices Safety Review) better known as the Cumberlege Review after Baroness Cumberlege who led it. The report of the two year long enquiry was published in July 2020 and recommendations to avoid similar situations arising in future were made. One of the recommendations was the establishment of Mesh Centres which could provide standardised care to women with mesh complications irres-pective of where they presented in the UK. Lessons need to be learned from the mesh saga, and though innovation cannot be stifled, safeguards to protect patients must be put in place when any new procedure or intervention is introduced into clinical practice.

Medicolegal Sidebar: Are Implant Sales Reps in the Operating Room Legally Untouchable?

Medicolegal Sidebar: Are Implant Sales Reps in the Operating Room Legally Untouchable?