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Different introducers are available to assist with tracheal intubation. Subtle differences in the design of introducers can have a marked effect on safety and performance. The Difficult Airway Society's Airway Device Evaluation Project Team proposal states that devices should only be purchased for which there is at least a case-control study on patients assessing airway devices. However, resources are not currently available to carry out a case-control study on all introducers available on the market. This study comprised a laboratory and manikin-based investigation to identify introducers that could be suitable for clinical investigation. We included six different introducers in laboratory-based assessments (design characteristics) and manikin-based assessments involving the participation of 30 anaesthetists. Each anaesthetist attempted placement in the manikin's trachea with each of the six introducers in a random order. Outcomes included first-time insertion success rate; insertion success rate; number of attempts; time to placement; and distance placed. Each anaesthetist also completed a questionnaire. First-time insertion success rate depended significantly on the introducer used (p = 0.0016) and varied from 47% (Armstrong and P3) to 77% (Intersurgical and Frova). Median time to placement (including oesophageal placement) varied from 10 s (Eschmann and Frova) to 20 s (P3) (p = 0.0025). Median time to successful placement in the trachea varied from 9 s (Frova) to 22 s (Armstrong) (p = 0.037). We found that the Armstrong and P3 devices were not as acceptable as other introducers and, without significant improvements to their design and characteristics, the use of these devices in studies on patients is questionable. The study protocol is suitable for differentiating between different introducers and could be used as a basis for assessing other types of devices.

ObjectivesIntraoperative fluorescence imaging is currently used in a variety of surgical fields for four main purposes: assessing tissue perfusion; identifying/localizing cancer; mapping lymphatic systems; and visualizing anatomy. To establish evidence-based guidance for research and practice, understanding the state of research on fluorescence imaging in different surgical fields is needed. We evaluated the evidence on fluorescence imaging for perfusion assessments using the Idea, Development,Exploration, Assessment, Long Term Study (IDEAL) framework, which was designed for describing the stages of innovation in surgery and other interventional procedures.DesignNarrative literature review with analysis of IDEAL stage of each field of study.SettingAll publications on intraoperative fluorescence imaging for perfusion assessments reported in PubMed through 2019 were identified for six surgical procedures: coronary artery bypass grafting (CABG), upper gastrointestinal (GI) surgery, colorectal surgery, solid organ transplantation, reconstructive surgery, and cerebral aneurysm surgery.Main outcome measuresThe IDEAL stage of research evidence was determined for each specialty field using a previously described approach.Results196 articles (15 003 cases) were selected for analysis. Current status of research evidence was determined to be IDEAL Stage 2a for upper GI and transplantation surgery, IDEAL 2b for CABG, colorectal and cerebral aneurysm surgery, and IDEAL Stage 3 for reconstructive surgery. Using the technique resulted in a high (up to 50%) rate of revisions among surgical procedures, but its efficacy improving postoperative outcomes has not yet been demonstrated by randomized controlled trials in any discipline. Only one possible adverse reaction to intravenous indocyanine green was reported.ConclusionsUsing fluorescence imaging intraoperatively to assess perfusion is feasible and appears useful for surgical decision making across a range of disciplines. Identifying the IDEAL stage of current research knowledge aids in planning further studies to establish the potential for patient benefit.

Uveitis is a major cause of ocular morbidity, potentially leading to significant visual impairment. The recent adoption of alternative drug delivery options has led to the development of new sustained-delivery corticosteroid systems, able to manage successfully chronic noninfectious posterior uveitis. The treatment goal is to target the site of inflammation with low dose of corticosteroids, delivered over an extended period of time, to minimize the cumulative damage resulting from repeated recurrences, reducing both injections frequency and ocular side effects. This article will review the pharmacology and preliminary clinical data of the 0.18 mg fluocinolone acetonide intravitreal implant (YUTIQ™), to show its efficacy and safety in the treatment of noninfectious posterior uveitis.

BACKGROUND Cardiac implantable electronic devices (CIEDs) are widely used according to consensus guidelines in various patient categories. The longevity of CIED is a major determinant of the frequency with which patients require device replacement. Given the mismatch between the useful life of the devices and patient survival, device replacement is often needed. There is a great variability in the criteria used by manufacturers to determine the longevity of pacemakers (PM), implantable defibrillators (ICDs) and devices for cardiac resynchronization therapy (CRT). Thus a fair comparison and an effective device evaluation is often difficult. METHODS The objective of this paper is to provide standardized criteria based on typical clinical settings for estimating the longevity of single and dual chamber ICDs, cardiac resynchronization defibrillators (CRT-D), single and dual chamber PMs and cardiac resynchronization PMs (CRT- P) to be used in heath technology assessment for an appropriate comparison among different devices. RESULTS The proposed parameters, if applied to the current marketed devices, provide longevity values in the range 5-17.2 years. CONCLUSION The values of longevity with the non-standardized criteria used by the manufacturers result in higher maximum values respect to the proposed standardized criteria for CRT-D, CRTD-MPP, CRT-P and Dual-chamber PM.

Numerical simulation is growing in its importance toward the design, testing and evaluation of medical devices. Computational fluid dynamics and finite element analysis allow improved calculation of stress, heat transfer, and flow to better understand the medical device environment. Current research focuses not only on improving medical devices, but also on improving the computational tools themselves. As methods and computer technology allow for faster simulation times, iterations and trials can be performed faster to collect more data. Given the adverse events associated with long-term inferior vena cava (IVC) filter placement, IVC filter design and device evaluation are of paramount importance. This work reviews computational methods used to develop, test, and improve IVC filters to ultimately serve the needs of the patient.

Type 1 diabetes (T1D) is a medical condition that requires constant management, including monitoring of blood glucose levels and administration of insulin. Advancements in diabetes technology have offered methods to reduce the burden on people with T1D. Several hybrid closed-loop systems are commercially available or in clinical trials, each with unique features to improve care for patients with T1D. This article reviews the Omnipod® 5 Automated Glucose Control System Powered by Horizon™ and the safety and efficacy data to support its use in the management of T1D.

Background The penumbra occlusion device (POD) is a recently developed metallic coil with a unique anchor segment. The purpose of this study was to investigate the anchoring function of the POD for embolization of medium-sized vessels in detail. Materials and methods We reviewed a series of cases of proximal embolization of medium-sized vessels in which the POD was used. Endovascular outcomes and complications were assessed. The distance between the distal end of the first-indwelled POD and the microcatheter tip was defined as the “landing distance,” and this was also evaluated via fluoroscopic analysis. Results POD deployment was successful in 17 of 18 patients. The median landing distance was 9.6 mm, and no distal POD migration was observed after the formation of anchor loops. Conclusions The specific anchoring function of the POD enables effective proximal occlusion of medium-sized vessels.

Extraglottic airway devices (EADs) have revolutionized the field of airway management. The invention of the laryngeal mask airway was a game changer, and since then, there have been several innovations to improve the EADs in design, functionality, safety and construction material. These have ranged from changes in the shape of the mask, number of cuffs and material used, like rubber, polyvinylchloride and latex. Phthalates, which were added to the construction material in order to increase device flexibility, were later omitted when this chemical was found to have serious adverse reproductive outcomes. The various designs brought out by numerous companies manufacturing EADs resulted in the addition of several devices to the airway market. These airway devices were put to use, many of them with inadequate or no evidence base regarding their efficacy and safety. To reduce the possibility of compromising the safety of the patient, the Difficult Airway Society (DAS) formed the Airway Device Evaluation Project Team (ADEPT) to strengthen the evidence base for airway equipment and vet the new extraglottic devices. A preuse careful analysis of the design and structure may help in better understanding of the functionality of a particular device. In the meantime, the search for the ideal EAD continues.

BACKGROUND AND PURPOSE: Tandem aneurysms are defined as multiple aneurysms located in close proximity on the same parent vessel. Endovascular treatment of these aneurysms has rarely been reported. Our aim was to evaluate the safety and efficacy of a single Pipeline Embolization Device for the treatment of tandem aneurysms of the internal carotid artery. MATERIALS AND METHODS: A retrospective analysis of consecutive aneurysms treated with the Pipeline Embolization Device between 2009 and 2016 at 3 institutions in the United States was performed. Cases included aneurysms of the ICA treated with a single Pipeline Embolization Device, and they were divided into tandem versus solitary. Angiographic and clinical outcomes were compared. RESULTS: The solitary group (median age, 58 years) underwent 184 Pipeline Embolization Device procedures for 184 aneurysms. The tandem group (median age, 50.5 years) underwent 34 procedures for 78 aneurysms. Aneurysms were primarily located along the paraophthalmic segment of the ICA in both the single and tandem groups (72.3% versus 78.2%, respectively, P = .53). The median maximal diameters in the solitary and tandem groups were 6.2 and 6.7 mm, respectively. Complete occlusion on the last angiographic follow-up was achieved in 75.1% of aneurysms in the single compared with 88.6%% in the tandem group (P = .06). Symptomatic thromboembolic complications were encountered in 2.7% and 8.8% of procedures in the single and tandem groups, respectively (P = .08). CONCLUSIONS: Tandem aneurysms of the ICA can be treated with a single Pipeline Embolization Device with high rates of complete occlusion. While there appeared to be a trend toward higher thromboembolic complication rates, this did not reach statistical significance.

To compare diabetic retinopathy (DR) identification and ungradable image rates between nonmydriatic ultrawide field (UWF) imaging and nonmydriatic multifield fundus photography (NMFP) in a large multistate population-based DR teleophthalmology program.Multiple-site, nonrandomized, consecutive, cross-sectional, retrospective, uncontrolled imaging device evaluation.Thirty-five thousand fifty-two eyes (17 526 patients) imaged using NMFP and 16 218 eyes (8109 patients) imaged using UWF imaging.All patients undergoing Joslin Vision Network (JVN) imaging with either NMFP or UWF imaging from May 1, 2014, through August 30, 2015, within the Indian Health Service-JVN program, which serves American Indian and Alaska Native communities at 97 sites across 25 states, were evaluated. All retinal images were graded using a standardized validated protocol in a centralized reading center.Ungradable rate for DR and diabetic macular edema (DME).The ungradable rate per patient for DR and DME was significantly lower with UWF imaging compared with NMFP (DR, 2.8% vs. 26.9% [P0.0001]; DME, 3.8% vs. 26.2% [P0.0001]). Identification of eyes with either DR or referable DR (moderate nonproliferative DR or DME or worse) was increased using UWF imaging from 11.7% to 24.2% (P0.0001) and from 6.2% to 13.6% (P0.0001), respectively. In eyes with DR imaged with UWF imaging (n = 3926 eyes of 2402 patients), the presence of predominantly peripheral lesions suggested a more severe level of DR in 7.2% of eyes (9.6% of patients).In a large, widely distributed DR ocular telehealth program, as compared with NMFP, nonmydriatic UWF imaging reduced the number of ungradable eyes by 81%, increased the identification of DR nearly 2-fold, and identified peripheral lesions suggesting more severe DR in almost 10% of patients, thus demonstrating significant benefits of this imaging method for large DR teleophthalmology programs.

Objectives Neonates in the neonatal intensive care unit often require considerable support with endotracheal tubes, umbilical arterial and venous catheters, and peripherally inserted central venous catheters. Support device evaluation with radiography exposes neonates to ionizing radiation. This study evaluated the effectiveness of sonographic localization for endotracheal tubes, umbilical arterial and venous catheters, and peripherally inserted central venous catheters. Methods This blinded prospective Institutional Review Board-approved, Health Insurance Portability and Accountability Act-compliant study with informed consent compared sonography to radiography for endotracheal tube, umbilical arterial and venous catheter, and peripherally inserted central venous catheter localization. Participants were consecutively recruited NICU patients of any weight, gestation, and chronologic age who had an endotracheal tube, umbilical arterial catheter, umbilical venous catheter, or peripherally inserted central venous catheter placed or adjusted and had subsequent radiographic confirmation within 24 hours. Sonographic evaluation was obtained as soon as possible, without prior review of the radiograph, and results were compared. Results Thirty sonographic studies were performed in 25 patients (14 male and 11 female), for a total of 50 lines and tubes: 18 umbilical venous catheters, 12 umbilical arterial catheters, 11 peripherally inserted central venous catheters, and 9 endotracheal tubes. Forty-nine support devices (98%) were visualized with sonography, all concordant with radiography. Forty-four were correctly positioned, and 6 were malpositioned. Sonography identified the location of umbilical venous catheters in all 18 cases (100%), umbilical arterial catheters in all 12 (100%), peripherally inserted central venous catheters in 10 (91%), and endotracheal tubes in 9 (100%). Conclusions The effectiveness of sonography was excellent for evaluation of umbilical arterial and venous catheters, endotracheal tubes, and peripherally inserted central venous catheters. These results support the goal of further point-of-care training and accreditation to use sonography as a primary modality for complete evaluation of NICU support devices.

The electrocardiogram (ECG) interpretation in patients with implantable pacemaker is often a perplexing problem. The difficulty in the device evaluation increases in the presence of novel timing cycles and additional functions. Authors describe a special function frequently encountered in Medtronic dual-chamber pacemakers and implantable cardioverter-defibrillator devices called managed ventricular pacing (MVP) and demonstrate its performance in the patient with undersensing episodes in ventricular channel. Intermittent ventricular undersensing in the device with MVP feature turned on caused repetitive mode switches between AAI and DDD mode. This report shows unexceptional occurrence of tricky ECG findings in patient with Medtronic dual-chamber device.

Onychomycosis is a difficult to treat fungal infection of the nails. The chronic nature of onychomycosis contributes to high recurrence rates and the difficulty in treating both dermatophyte and non-dermatophyte infections. It has been hypothesized that the formation of biofilms, sessile, multicellular communities of fungi surrounded by a protective extracellular matrix, allow for fungi to evade current antifungal therapies and contribute to observed antifungal resistance. This review presents the experimental evidence that has accumulated in recent years implicating biofilms in the pathogenesis of onychomycosis. Dermatophytes, non-dermatophyte molds, and yeasts form biofilms in vitro and a model using ex vivo healthy nail fragments has demonstrated biofilm formation on nails for dermatophyte, Candida, and Fusarium species. Implications for disease management are discussed with further research required to incorporate biofilm formation into future drug/device evaluation and treatment protocols.

The objective of this study was to determine the accuracy of the Hingmed WBP-02A device for ambulatory blood pressure (BP) monitoring according to the International Protocol of the European Society of Hypertension (ESH-IP). Device evaluation was carried out in 33 patients. The mean age was 69.8±13.8 years, the mean systolic BP was 137.6±27.0 mmHg (range: 96-172), the mean diastolic BP was 86.7±20.1 mmHg (range: 48-124) and the mean arm circumference was 30.1±6.2 cm (range: 20-43). The protocol requirements were followed precisely. Four different cuffs, small, standard, large, and extra-large were used. The device comfortably passed all ESH-IP requirements, as 84 out of 99 device-observer systolic BP differences and 97 of 99 diastolic BP differences were within ±5 mmHg thereby fulfilling the standards of the protocol. Device-observer BP differences were unrelated to arm circumference. These data show that the Hingmed WBP-02A device for ambulatory BP monitoring met the requirements for validation by the ESH-IP and can be recommended for clinical use in the adult population.

Purpose To evaluate the patency and the freedom of target lesion revascularization of the 4-French Pulsar-18 self-expandable (SE) nitinol stent for the treatment of long femoropopliteal occlusive disease in a two-center, prospective, all-comers registry with a follow-up period of 12 months. Methods This registry enrolled 36 patients with symptomatic femoropopliteal long lesions for recanalization and implantation of the 4-French Pulsar-18 SE nitinol stent. Routine follow-up examination including duplex ultrasound was performed after 6 and 12 months. Primary patency was defined as no binary restenosis on duplex ultrasound (Peak systolic velocitiy ration (PSVR) Results Average lesion length of the femoropopliteal segment was 182.3 ± 51.8 mm. Mean stent implantation length was 181.5 ± 35.4 mm. Total occlusion was present in 46 of the 48 (95.8%) treated lesions. Involvement of popliteal segment I–III was present in 3 (6.3%) lesions. The primary patency after 6 and 12 months was 87.5% and 85.4%, respectively. The clinically driven overall freedom from target lesion revascularization (fTLR) was 89.6% after 6 months and 87.5% after 12 months. ABI, pain-free walking distance and Rutherford category, all improved significantly ( P < 0.001) after 6 and 12 months. The primary patency rate in patients with diabetes ( P = 0.18) and renal insufficiency ( P = 0.3) was not significantly lower as compared to the overall primary patency. Conclusions In this two-center, all-comers registry, the use of the Pulsar-18 SE nitinol stent for endovascular intervention of femoropopliteal disease with a mean lesion length of 182.3 ± 51.8 mm showed promising primary patency and fTLR rates after 6 and 12 months. Diabetes and renal insufficiency had no negative impact on the patency rate.

Recent technological advances in the management of patients with cardiovascular implantable electronic devices (CIEDs) have expanded clinicians' ability to remotely monitor patients with CIEDs. Remote monitoring, in addition to periodic in-person device evaluation, provides many advantages to patients and clinicians. Aside from the therapeutic and diagnostic benefits of pacemakers, implantable cardioverter-defibrillators, cardiac resynchronization therapy devices, and implantable loop recorders, improvement in clinical outcomes, clinical efficiencies, and patient experience can be realized with the adoption of remote CIED monitoring. These advantages create significant value to both patients and CIED follow-up centers.

During routine endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) procedures, especially with biopsy of lymph nodes in or around the left upper lobe, frequent reports have noted the loss of ultrasound image and needle angulation leading to an inability to biopsy nodes visualised by EBUS. The aim of this research was to investigate and compare this loss of angulation with commercially available scopes. Bench-top experiments and a clinical case study demonstrated the varying loss of scope angulation, flexibility and manoeuvrability with different scopes and biopsy instruments leading to procedural implications. Improvements in both the EBUS scope and needle characteristics are required to overcome this limitation which has implications in bronchoscope navigation and the diagnostic yield of EBUS-TBNA.

The objective of this study was to determine the accuracy of the Thermor BIOS BD215 device for home blood pressure (BP) measurement according to the International Protocol of the European Society of Hypertension (ESH). Device evaluation was carried out in 33 patients. The mean age of the patients was 57.0 ± 15.0 years, the mean systolic BP was 142.0 ± 20.3 mmHg (range 100-177 mmHg), the mean diastolic BP was 88.0 ± 14.6 mmHg (range 48-123 mmHg), and the mean arm circumference was 28.0 ± 3.0 cm (range 24-33 cm). The protocol requirements were followed precisely. The device passed all requirements, fulfilling the standards of the protocol. On average, the device overestimated the systolic BP by 0.6 ± 4.2 mmHg and underestimated diastolic BP by -0.5 ± 3.2 mmHg. The device-observer discrepancies were unrelated to patients' clinical characteristics. These data show that the Thermor BIOS BD215 device fulfilled the requirements for validation by the International Protocol and can be recommended for clinical use in the adult population.

To the Editor: According to the Society for Simulation in Healthcare, “Simulation is the imitation or representation of one act or system by another. Healthcare simulations can be said to have 4 main purposes – education, assessment, research, and health system integration in facilitating

Background: Postpartum intrauterine contraceptive device is inserted within 10 minutes to 48 hours of expulsion of placenta. The objective of the study was to determine acceptability, safety and complications of PPIUCD in tertiary care center.Methods: This is a retrospective study conducted at Zenana Hospital, SMS Medical College, Jaipur over a period of 1 year from April 2018 to March 2019. Women were followed after 6 weeks and their complaints and various parameters were analyzed.Results: 5653 women were inserted PPIUCD during 1 year period. Acceptance rate was 29.26% and higher in multipara (54.30%) and between 18 to 25 years of age (50.29%). The main complaints at follow-up were pain and bleeding which were dealt mainly by reassurance. Main cause of removal was bleeding, pain and family pressure.Conclusions: The acceptance was high in this study group. PPIUCD is safe, effective and acceptable with negligible side effects. PPIUCD has abundant scope in India where accessibility for contraception is lower during interval period and women do not come for follow-up after delivery.

Background Closed system transfer device (CSTD) mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapour concentrations outside the system. However, various CSTDs are not equally effective. Purpose We evaluated the impact of current and new CSTD systems on exposure of healthcare personnel to chemotherapy agents and how the new CSTD would fit into our workflow. Material and methods To ensure safety and compliance of a new CSTD system, our first step was a hands-on product demonstration to evaluate the new technology. The review included ease of use of the system and review of all system components. The second step was to take surface wipe samples. We used CytoWipe kits from Exposure Control. We carried out two compounding trials (existing CSTD and new CSTD), each lasting 3 weeks. Sampling locations in pharmacy included: Scale in the laminar flow cabinet (LAF) LAF surface. Counter with prepared chemotherapy. Floor in front of the LAF. Pass through surface. Vials. Baseline contamination was determined with initial cleaning with NaOH and HCl. During the trials, cleaning was performed per facility protocol (detergent, IPA and biocid B or C (KlerWipe) daily and 0.05 M NaOH weekly). Monitored drugs were cyclophosphamide and 5-fluorouracil. Exposure Control analysed cyclophosphamide using a GC-MSMS method and 5-fluorouracil using a HPLC system with UV detection. Results We found that while both systems were easy to use, the new CSTD system provided enhanced safety by ensuring compliance without an option to bypass the system. The limited surface wipe sample analysis showed that cleaning and workflow were important factors in minimising exposure of healthcare personnel to chemotherapy agents. With the current CSTD system, cyclophosphamide contamination was found on surfaces 1, 2 and 4, and barely detectable on 5 and 6. No contamination with 5-fluorouracil was found. With the new CSTD, cyclophosphamide contamination was found only on surfaces 4 and 6 that had little or no correlation with compounding. No contamination with 5-fluorouracil was found. Conclusion The study showed that the new CSTD system ensures compliance, fits into our workflow and can help minimise exposure of healthcare personnel to chemotherapy agents. No conflict of interest

Background The present study evaluates the feasibility of a shape memory polymer (SMP) device for fallopian tube occlusion in rabbits. Study design The SMP contraceptive device is made of poly( dl -lactic acid)-based poly(urethane urea) SMP in the shape of a spiral cylinder that was 10 mm long and had a diameter of 2.6 mm. Using this device, bilateral transuterine fallopian tube occlusions were performed in 78 New Zealand white female rabbits. Forty-eight female rabbits (Group 1) were chosen as the experimental group and were implanted with the SMP devices. The remaining 30 female rabbits (Group 2) served as the control group, which only received an incision in the abdomen but no SMP device. Follow-up consisted of hysterosalpingography, histologic evaluation and contraceptive effect. In addition, the shape memory behavior and in vivo degradation characterization of the SMP device were observed in this study. Results Under heat (37°C) stimulation, the temporary shape SMP device returned to its permanent shape within 60 s. The average weight loss percentage of SMP devices was 7.0% at 2 weeks and 72.5% at 12 weeks. The inflammatory reactions caused by SMP devices were aseptic and nonspecific at 2 and 12 weeks, respectively. The SMP device boundaries and the surrounding tissues were obscured by fiber hyperplasia in 11/12 tubes at 24 weeks. Hysterosalpingography showed an occluded fallopian tube of Group 1 in 6/6 rabbits at 12 weeks and 6/6 rabbits at 24 weeks. No pregnancy was found in all 18 rabbits of Group 1 (contraceptive rate of 100%); all 20 rabbits in the control group were pregnant. Conclusion Biodegradable and biocompatible SMP devices could provide reliable, instant and permanent tubal occlusion.

Implantable cardiac devices have become the mainstay of the treatment of patients with heart disease. However, data regarding their reliability and, inferentially, safety have been called into question. We reviewed annual reports submitted to the Food and Drug Administration Office of Device Evaluation by device manufacturers from 2003 to 2007. The annual number of implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillator (CRT-D) implants, explants, and returned devices were tabulated along with the cumulative (Cum) number of implants for each device. We derived an annual explantation rate (AER) defined as the ratio of the annual number of explants less the number of normal battery depletions/Cum (×1000). From 2003 to 2007, 256,392 CRT-D and 459,300 ICD devices were implanted in the United States. The overall mean (±SD) AERs for ICD and CRT-D devices were, respectively, 49.5 (15.6) per 1000 ICD devices and 82.6 (35.5) per 1000 CRT-D devices. The AER for each device type significantly decreased over the study period (P for trend

The superior sensitivity and specificity associated with the use of molecular assays has greatly improved the field of infectious disease diagnostics by providing clinicians with results that are both accurate and rapidly obtained. Herein, we review molecularly based infectious disease diagnostic tests that are Food and Drug Administration approved or cleared and commercially available in the United States as of December 31, 2010. We describe specific assays and their performance, as stated in the Food and Drug Administration's Summary of Safety and Effectiveness Data or the Office of In Vitro Diagnostic Device Evaluation and Safety's decision summaries, product inserts, or peer-reviewed literature. We summarize indications for testing, limitations, and challenges related to implementation in a clinical laboratory setting for a wide variety of common pathogens. The information presented in this review will be particularly useful for laboratories that plan to implement or expand their molecular offerings in the near term.

Introduction: Patients in underdeveloped nations have limited access to life-saving medical technology including cardiac rhythm management (CRM) devices. We evaluated alternative means to provide such technology to this patient population while assessing the safety and efficacy of such a practice. Methods: Patients in the United States with clinical indications for extraction of CRM devices were consented. Antemortem CRM devices were cleaned and sterilized following a protocol established at our institution. Surveillance in vitro cultures were performed for quality assurance. The functional status of pulse generators was tested with a pacing system analyzer to confirm at least 70% battery life. Most generators were transported, in person, to an implanting institution in Nicaragua. Recipients with a Class I indication for CRM implantation, and meeting economical criteria set forth, were consented for implantation of a recycled device. Results: Between 2003 and 2009, implantation was performed in 17 patients with an average age of 42.1 ± 20.3 years. Of the 17 patients, nine were male and eight were female. Mean follow-up was 68 ± 38 months. Device evaluation occurred prior to discharge, 4 weeks post implantation, and every 6 months thereafter. There were three deaths during the follow-up period secondary to myocardial infarction, stroke, and heart failure. Hematoma formation occurred in one patient. No infections, early battery depletion, or device malfunction were identified during follow-up. Conclusions: Our case series is the longest follow-up of recipients of recycled antemortem CRM devices. Our findings support the feasibility and safety of this alternative acquisition of life-saving technology. (PACE 2011; 653–658)

In Reply: Mr Chatburn begins his letter explaining what should be simulation in medicine. Many of the ventilator bench studies published before are only bench tests, as our study, and not a simulation of a more complex reality. The goal of this study was to test transport ventilators under

This review explores recent trends in the development and evaluation of assistive robotic arms, both prosthetic and externally mounted. Evaluations have been organized according to the CATOR taxonomy of assistive device outcomes, which takes into consideration device effectiveness, social significance, and impact on subjective well-being. Questions that have informed the review include: (1) Are robotic arms being comprehensively evaluated along axes of the CATOR taxonomy? (2) Are definitions of effectiveness in accordance with the priorities of users? (3) What gaps in robotic arm evaluation exist, and how might these best be addressed? (4) What further advances can be expected in the next 15 years? Results highlight the need for increased standardization of evaluation methods, increased emphasis on the social significance (i.e., social cost) of devices, and increased emphasis on device impact on quality of life. Several open areas for future research, in terms of both device evaluation and device development, are also discussed.

Objectives To clinically evaluate an inflation-based algorithm incorporated into a new automated blood pressure monitor manufactured by Welch Allyn, Inc. Methods Device evaluation was performed according to the Association for the Advancement of Medical Instrumentation standard. An overabundance of patients with hypertension (32) were part of the 110 total participants. The data were also analyzed as described in the British Hypertension Society protocol. Results The mean error and standard deviation for systolic blood pressure were -0.9 mmHg+/-7.2; for diastolic blood pressure -2.2 mmHg+/-6.7. These passed the Association for the Advancement of Medical Instrumentation standard requirements. By British Hypertension Society data analysis, the device achieved an AA grading. Over 90% of the cycles' blood pressure values were obtained during inflation. Conclusions The SureBP inflation-based algorithm successfully passed the Association for the Advancement of Medical Instrumentation standard requirements and achieved an AA rating by British Hypertension Society data analysis. The monitor has great advantages for patient comfort and speed of readings (average 15 s per reading). As the population studied was skewed by including a much larger than needed number of patients with hypertension, clinicians can have added confidence in this new technology.

The laryngeal mask airway (LMA) has been used in various animal species anesthetized for the purpose of device evaluation, but the device has not been evaluated in rabbits during surgery. The authors tested the feasibility and potential advantages of using the LMA in 50 rabbits undergoing surgery under spontaneous-breathing inhalational anesthesia, focusing mainly on the technique of insertion and its efficacy. The LMA was easily inserted and no air leakage at the larynx was detected. Although four rabbits developed lingual cyanosis, this was reversible and most likely due to lingual vascular compression by the LMA. The authors conclude that the LMA is an attractive alternative to endotracheal intubation, as the mask can be inserted easily and rapidly and its correct placement is easily confirmed.

Porous tantalum implants are used in early osteonecrosis of the hip. Device evaluation included surgical time, blood loss, hospitalization, patient-controlled analgesia use, transfusions, implant survival, and outcomes. Mean blood loss was 70 mL. Mean operative time was 36 minutes. Average hospitalization was less than 1 day. No patient required patient-controlled analgesia use or transfusions. Results were compared to a historical vascularized fibular graft population. All parameters were less than the fibular graft groups (P < .00001). All surviving implants (86%) resulted in good to excellent outcomes. Kaplan-Meier analysis at 39 months was 86% and 67% for the implant and fibular graft, respectively (P = .21). Early outcomes demonstrate that porous tantalum implants are a safe option for femoral head salvage. Continued follow-up is necessary to determine the long-term success.

Objectives To determine the accuracy of the UA-774 (UA-767Plus) blood pressure monitor developed by the A&D Company. Methods Device evaluation was performed according to the modified British Hypertension Society (BHS) protocol released in 1993. Eighty-five subjects with characteristics outlined in the BHS protocol were recruited among those attending the outpatient clinic of the Department of Cardiovascular Disease, Hospital 'R. Silvestrini', Perugia, Italy. The A&D blood pressure monitor was evaluated according to the various steps of the protocol. Sequential readings were taken for the main validation test. Outcome was classified according to the criteria of BSH recommendations, which are based on four areas of accuracy differing from the mercury standard by 5, 10 and 15 mmHg, or more. Results The device achieved a grade A for systolic and a grade A for diastolic blood pressure. Mean blood pressure difference (+/-1 SD) between device and observers was -1.01+/-7.14 mmHg for systolic blood pressure and -1.42+/-7.61 mmHg for diastolic blood pressure. There was no systematic change in the device-observed difference over a wide range of blood pressure values Conclusions These data show that the A&D UA-774 (UA-767Plus) device satisfies the BSH recommendations for accuracy for systolic and diastolic blood pressure.

OBJECTIVE—The objective of this study was to introduce continuous glucose–error grid analysis (CG-EGA) as a method of evaluating the accuracy of continuous glucose-monitoring sensors in terms of both accurate blood glucose (BG) values and accurate direction and rate of BG fluctuations and to illustrate the application of CG-EGA with data from the TheraSense Freestyle Navigator. RESEARCH DESIGN AND METHODS—We approach the design of CG-EGA from the understanding that continuous glucose sensors (CGSs) allow the observation of BG fluctuations as a process in time. We account for specifics of process characterization (location, speed, and direction) and for biological limitations of the observed processes (time lags associated with interstitial sensors). CG-EGA includes two interacting components: 1) point–error grid analysis (P-EGA) evaluates the sensor’s accuracy in terms of correct presentation of BG values and 2) rate–error grid analysis (R-EGA) assesses the sensor’s ability to capture the direction and rate of BG fluctuations. RESULTS—CG-EGA revealed that the accuracy of the Navigator, measured as a percentage of accurate readings plus benign errors, was significantly different at hypoglycemia (73.5%), euglycemia (99%), and hyperglycemia (95.4%). Failure to detect hypoglycemia was the most common error. The point accuracy of the Navigator was relatively stable over a wide range of BG rates of change, and its rate accuracy decreased significantly at high BG levels. CONCLUSIONS—Traditional self-monitoring of BG device evaluation methods fail to capture the important temporal characteristics of the continuous glucose-monitoring process. CG-EGA addresses this problem, thus providing a comprehensive assessment of sensor accuracy that appears to be a useful adjunct to other CGS performance measures.

Federal regulation of medical devices began in 1976 with the signing of the Medical Device Amendments to the Food, Drug and Cosmetic Act. For the purpose of regulating medical devices, the Food and Drug Administration is divided into various divisions and branches, including the Office of Device Evaluation. The evolution of the Food and Drug Administration's regulations of laparoscopic devices is described. Also described is the technology of laparoscopic surgical devices and how they are regulated by the Office of Device Evaluation. Trends towards the future of laparoscopic devices, and their regulation, are reviewed.

The arrival of drug-eluting stents raises important questions about preclinical evaluation of devices and the optimal means of predicting clinical safety and efficacy. The Interventional, Regulatory, Commercial, and Scientific communities have all asked for assistance in defining criteria for device evaluation. This document is an integrated view of requirements for evaluating drug-eluting stents in preclinical models. The suggested requirements encompass study design, experimental performance, and histopathologic evaluations, emphasizing safety and efficacy at multiple points in time. This is a consensus document assembled by clinical, academic, and industrial investigators engaged in preclinical interventional device evaluation. Suggested requirements might well serve as a standard but do not prescribe a single manner in which all devices should be evaluated. They instead motivate such an evaluation and describe how examinations might be performed. It is understood that methods will change and knowledge will evolve, in particular as corroboration is established with clinical data. The dynamic nature of this document allows for future modifications and additions. A drug-eluting stent presents or releases single or multiple bioactive agents into the blood stream. The drug can deposit in and/or affect blood vessels, cells, plaque, or tissues either adjacent to the stent or at a distance. Systemic drug concentrations may be avoided or desirable. It is assumed that drugs undergoing preclinical evaluation will have sound theoretical and practical reasons for biological success, and that the preclinical studies will help answer the magnitude and safety of effect when presented with or from the stent. It is likely that substantial empirical data already exists documenting the effects of these drugs on isolated cells in culture and even in vivo after systemic administration. Some drugs may already be in clinical use. Drug can be embedded and released from within (“matrix-type”) or surrounded by and released through (“reservoir-type”) polymer materials that coat …

Objective To validate the UEBE Visomat Double Comfort, an upper arm blood pressure monitor designed for self-measurement of blood pressure and for clinical use in a general population according to the European Society of Hypertension International Protocol revision 2010. Methods The device is provided with two operational modalities, a microphonic mode and an oscillometric mode. In this study, the oscillometric modality was tested. Device evaluation was performed in 33 participants with a mean ± standard deviation age of 56.3 ± 20.0 years (range, 25-85 years). Their systolic blood pressure was 140.4 ± 27.7 mmHg, diastolic blood pressure was 86.8 ± 17.2 mmHg, and arm circumference was 29.3 ± 3.9 cm. Results The protocol requirements were followed precisely. The device passed all of the requirements fulfilling the standards of the protocol. Mean blood pressure differences between device and observer were -0.9 ± 4.1 mmHg for systolic blood pressure and -0.1 ± 3.3 mmHg for diastolic blood pressure. Conclusion As the Visomat Double Comfort in the oscillometric modality has achieved the required standards, it is recommended for clinical use in an adult population.

Objective To test the accuracy of the TRANSTEK home blood pressure monitor TMB-986 using the International Protocol of the European Society of Hypertension. Method Device evaluation was performed on 33 participants (15 men and 18 women) with a mean±standard deviation age of 56.2±12.8 years (range: 35-80 years). Blood pressures (systolic blood pressure; SBP and diastolic blood pressure; DBP) were sequentially measured using mercury sphygmomanometer (two trained observers) and alternately measured by the test device (one supervisor). Results In phase 1, 35, 44, 45 of SBP measurements and 41, 45, 45 of DBP measurements were within 5, 10, 15 mmHg. In phase 2.1, 70, 94, 99 of SBP measurements and 78, 93, 99 of DBP measurements were within 5, 10, 15 mmHg. In addition, the difference between the device and the mean of two observers was 2.2±5.0 and 1.7±4.8 mmHg for SBP and DBP, respectively. In phase 2.2, for SBP and DBP, respectively, 25 and 26 of 33 participants had at least two of their three differences with 5 mmHg and there were two and one participants who did not have any difference within 5 mmHg. Conclusion The TRANSTEK blood pressure monitor TMB-986 passed all the phases of the International Protocol both for SBP and DBP and is recommended for home use.

PURPOSE A number of percutaneous thrombectomy devices are undergoing investigation for treatment of patients with venous thromboembolism. Use of radiopaque thrombus to monitor thrombus delivery and assess thrombectomy has been previously reported. The purpose of this project was to quantitatively test the effect of mixing different ratios of blood and contrast material to facilitate maximum thrombus formation and radiopacity. MATERIALS AND METHODS The following ratios of blood and contrast material were mixed: 2 mL blood to 8 mL contrast material (ratio = 0.25), 4 mL blood to 6 mL contrast material (ratio = 0.67), 6 mL blood to 4 mL contrast material (ratio = 1.5), and 8 mL blood to 2 mL contrast material (ratio = 4). Contrast material was added at day 0, 3, or 6. Each sample received one of two ionic contrast agents to opacify the clots. At day 14, thrombus mass and opacity were determined. RESULTS Three combinations of blood and contrast material produced maximum thrombus and radiopacity. These were sodium iothalamate 30% with a ratio of 4 with contrast material added on day 0 and sodium iothalamate 60% with a ratio of 1.5 with contrast material added on day 3 or 6. CONCLUSIONS When forming radiopaque thrombi, significant differences can result from the ratio of blood to contrast material used. Contrast material type can also affect radiopacity and mass formed. The use of optimal ratios of blood to contrast material should maximize device evaluation with minimal wasting of valuable resources such as test subjects, physician time, and equipment.

A new occlusion device designed for use in a patent ductus arteriosus was tested in an animal model.The device consists of a self-expanding conical-shaped stainless steel mesh, with hooks encircling the expanding end acting to secure the device within the ductus. A screw thread at the apex allows attachment to a stylet, and a 6 F delivery system is used. Placement of the device was attempted in 20 canines that previously had a vascular graft surgically inserted between the descending thoracic aorta and main pulmonary artery, creating the patent ductus model. Angiographic follow-up at regular intervals was performed over a 3-month period.Early cases resulted in device misplacement and migration because of inaccurate assessment of ductus position and size. In 15 canines the device was placed within the ductus and regularly assessed over the 3-month placement period. Ductus occlusion occurred within 1 week in 12 of 13 dogs (92%) when device placement was considered ideal. In two dogs where significant protrusion of the device from the ductus was evident (either into the aorta or main pulmonary artery) ductus closure was delayed but present by 3 months, resulting in a 93% overall closure rate at this time. In one dog, the ductus remained partially opened.This self-expanding patent ductus arteriosus occlusion device is promising. The 6 F delivery system is advantageous over other devices currently available, making it more suited for use in the pediatric population. Accurate assessment of the ductus is imperative, however, to enable correct device sizing. The screw thread system allows the device to be repositioned if desired prior to deployment.

On May 26, 1976, the Food and Drug Administration (FDA) began implementing the Medical Device Amendments to the Federal Food Drug and Cosmetic Act. These amendments give FDA specific authority to regulate "medical devices." Additional authority was provided in the Safe Medical Devices Act of 1990. The pathways to get in vitro diagnostic products to market for commercial distribution include: premarket notification [or 510(k)] and premarket approval (PMA). Reviews of these applications are performed in the Division of Clinical Laboratory Devices, Office of Device Evaluation within the Center for Devices and Radiological Health. Most submissions for invasive glucose devices are 510(k) applications. Through this process the manufacturer demonstrates that its device is substantially equivalent to another device that is already legally marketed, referred to as the predicate device. To date, noninvasive and minimally invasive glucose testings have been approved through the PMA process and will be discussed in a separate article.

During this fifth year of the project our efforts have continued to focus on the regulatory aspects of this clinical trail. We had already successfully obtained an Investigational Device Exemption from the FDA Center for Devices and Radiological Health Office of Device Evaluation and approval of the proposal from the University of Pittsburgh and University of Maryland Institutional Review Boards (IRB) for study enrollment, pending community consultation and public disclosure.

Clinical assessment of outcome for post heart transplant recipients who were bridged with ventricular assist device is essential for service evaluation, device evaluation and audit. This chapter will provide a summary assessment of clinical studies and reviews. While most of the data available is retrospective, important aspects of this assessment relies on the quality of assessment and timely re-evaluation of strategy used in the assessment. We will review the clinical outcomes measured so far in the field of heart transplant recipients who were bridged with VAD. In this chapter we will review the ongoing methods of assessment of outcomes for transplant recipients bridged by VAD and discuss the potential challenges facing the clinicians. We will finalize with brief conclusions and future directions.

Objective The study objective was to evaluate patient safety, increase nursing satisfaction, and affect economic factors through implementation of intelligent intravenous (IV) infusion devices in a specialty cardiac hospital. Intelligent IV infusion devices have been shown to decrease medication errors associated with inpatient infusions. Methods Intelligent IV infusion device evaluation and drug library creation were conducted by a multidisciplinary team within the hospital. Devices were then implemented into patient care, and the impact was analyzed over a 9-month period. Results Post-implementation data showed that compliance was approximately 100%. A total of 494 critical catches occurred over the study period, resulting in an estimated annual savings of $7,513,333. End-users became familiar with the new technology and recognized the increase in safety measures and time spent with patients. Conclusion This evaluation suggests that intelligent IV infusion devices resulted in decreased costs and a safer environment for patients.

Objective To evaluate the accuracy of the TRANSTEK TMB-988 for home blood pressure monitoring according to the International Protocol of the Working Group on Blood Pressure Monitoring of the European Society of Hypertension. Method Device evaluation was done in 33 participants (16 men and 17 women) with a mean±SD age of 58.2±11.8 years (range 32-80 years). Blood pressures [systolic blood pressure (SBP) and diastolic blood pressure (DBP)] were sequentially measured using mercury sphygmomanometer (by two trained observers) and alternately measured by the test device (by one supervisor). Results In phase 1, a total of 33, 42, and 44 of SBP differences and 40, 43 and 45 of DBP differences were within 5, 10 and 15 mmHg, respectively. In phase 2.1, 68, 93, and 97 of SBP differences and 75, 92 and 98 of DBP differences were within 5, 10 and 15 mmHg. The difference between the device and the mean of two observers was -0.6±5.0 mmHg for SBP and 0.2±5.8 mmHg for DBP, respectively. In phase 2.2, for SBP and DBP, respectively, 27 and 26 participants had at least two of their three differences with 5 mmHg, and there were two participants who did not have any difference within 5 mmHg for both SBP and DBP. Conclusion The TRANSTEK TMB-988 successfully passed all the phases and is recommended for home use in adults.

The American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee provides reviews of existing, new, or emerging endoscopic technologies that have an impact on the practice of GI endoscopy. Evidence-based methodology is used by performing a MEDLINE literature search to identify pertinent clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported complications of a given technology. Both are supplemented by accessing the "related articles" feature of PubMed and by scrutinizing pertinent references cited by the identified studies. Technology Status Evaluation Reports are drafted by 1 or 2 members of the ASGE Technology Committee, reviewed and edited by the committee as a whole, and approved by the Governing Board of the ASGE. When financial guidance is indicated, the most recent coding data and list prices at the time of publication are provided. For this review, the MEDLINE database was searched through October 2009 for articles and references related to devices and the U.S. Food and Drug Administration by using the keywords "FDA" and "devices." In addition, the Web was searched using the same keywords. The U.S. Food and Drug Administration website was also thoroughly reviewed. Practitioners should continue to monitor the medical literature for subsequent data about these issues. Technology Status Evaluation Reports are scientific reviews provided solely for educational and informational purposes. Technology Status Evaluation Reports are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment or payment for such treatment.

The objective of this study was to determine the accuracy of the Microlife BP A100 blood pressure measuring device tested according to the requirements of the International Protocol of the European Society of Hypertension. The BP A100 model is designed to provide accurate blood pressure measurements over a wide range of arm circumferences using a single cuff with standard-size bladder. Device evaluation was performed on 33 patients with a mean +/- SD age of 59 +/- 19 years (range 30-89 years). Their systolic blood pressure (SBP) was 143 +/- 23 mmHg (range 108-180 mmHg), diastolic blood pressure (DBP) was 87 +/- 16 mmHg (range 60-108 mmHg), and arm circumference was 31 +/- 4 cm (range 22-42 cm). In nine patients, the arm circumference was at least 33 cm. Blood pressure measurements were performed in the sitting position. The BP A100 passed all three phases of the European Society of Hypertension protocol for SBP and DBP. Mean blood pressure differences between device and observer were -2.9 +/- 4.9 mmHg for SBP and -2.6 +/- 4.6 mmHg for DBP. Similar device-observer differences were observed in the patients divided into two subgroups according to whether their arm circumference was above or below the median in the group. In conclusion, the present results indicate that the Microlife BP A100 monitor coupled with a single cuff with standard size bladder provides accurate blood pressure readings over a wide range of arm circumferences.