Managing the risks of medical technology: Do hazard surveillance systems provide an early warning of medical device problems?

The Food and Drug Administration (FDA) is responsible for risk assessment and risk management in the post-market surveillance of the U.S. medical device industry. One of the FDA regulatory mechanisms, the Medical Device Reporting System (MDR) is an adverse event reporting system intended to provide the FDA with advance warning of device problems. It includes voluntary reporting for individuals, and mandatory reporting for device manufacturers. ^ In a study of alleged breast implant safety problems, this research examines the organizational processes by which the FDA gathers data on adverse events and uses adverse event reporting systems to assess and manage risk. The research reviews the literature on problem recognition, risk perception, and organizational learning to understand the influence highly publicized events may have on adverse event reporting. Understanding the influence of an environmental factor, such as publicity, on adverse event reporting can provide insight into the question of whether the FDA's adverse event reporting system operates as an early warning system for medical device problems. ^ The research focuses on two main questions. The first question addresses the relationship between publicity and the voluntary and mandatory reporting of adverse events. The second question examines whether government agencies make use of these adverse event reports. ^ Using quantitative and qualitative methods, a longitudinal study was conducted of the number and content of adverse event reports regarding breast implants filed with the FDA's medical device reporting system during 1985–1991. To assess variation in publicity over time, the print media were analyzed to identify articles related to breast implant failures. ^ The exploratory findings suggest that an increase in media activity is related to an increase in voluntary reporting, especially following periods of intense media coverage of the FDA. However, a similar relationship was not found between media activity and manufacturers' mandatory adverse event reporting. A review of government committee and agency reports on the FDA published during 1976–1996 produced little evidence to suggest that publicity or MDR information contributed to problem recognition, agenda setting, or the formulation of policy recommendations. ^ The research findings suggest that the reporting of breast implant problems to FDA may reflect the perceptions and concerns of the reporting groups, a barometer of the volume and content of media attention. ^

A new rechargeable device for deep brain stimulation: a prospective patient satisfaction survey

Background: Deep brain stimulation (DBS) is highly successful in treating Parkinson's disease (PD), dystonia, and essential tremor (ET). Until recently implantable neurostimulators were nonrechargeable, battery-driven devices, with a lifetime of about 3-5 years. This relatively short duration causes problems for patients (e.g. programming and device-use limitations, unpredictable expiration, surgeries to replace depleted batteries). Additionally, these batteries (relatively large with considerable weight) may cause discomfort. To overcome these issues, the first rechargeable DBS device was introduced: smaller, lighter and intended to function for 9 years. Methods: Of 35 patients implanted with the rechargeable device, 21 (including 8 PD, 10 dystonia, 2 ET) were followed before and 3 months after surgery and completed a systematic survey of satisfaction with the rechargeable device. Results: Overall patient satisfaction was high (83.3 ± 18.3). Dystonia patients tended to have lower satisfaction values for fit and comfort of the system than PD patients. Age was significantly negatively correlated with satisfaction regarding process of battery recharging. Conclusions: Dystonia patients (generally high-energy consumption, severe problems at the DBS device end-of-life) are good, reliable candidates for a rechargeable DBS system. In PD, younger patients, without signs of dementia and good technical understanding, might have highest benefit.

Effects of Thoratec pulsatile ventricular assist device (PVAD) timing on the abdominal aortic wave intensity pattern

Arterial waves are seen as possible independent mediators of cardiovascular risks, and the wave intensity analysis (WIA) has therefore been proposed as a method for patient selection for ventricular assist device (VAD) implantation. Interpreting measured wave intensity (WI) is challenging and complexity is increased by the implantation of a VAD. The waves generated by the VAD interact with the waves generated by the native heart, and this interaction varies with changing VAD settings. Eight sheep were implanted with a pulsatile VAD (PVAD) through ventriculo-aortic cannulation. The start of PVAD ejection was synchronized to the native R-wave and delayed between 0 % - 90 % of the cardiac cycle in 10 % steps or phase shifts (PS). Pressure and velocity signals were registered, using a combined Doppler and pressure wire positioned in the abdominal aorta, and used to calculate the WI. Depending on the PS, different wave interference phenomena occurred. Maximum unloading of the left ventricle (LV) coincided with constructive interference and maximum blood flow pulsatility, and maximum loading of the LV coincided with destructive interference and minimum blood flow pulsatility. We believe, that non-invasive WIA could potentially be used clinically to assess the mechanical load of the LV, and to monitor the peripheral hemodynamics such as blood flow pulsatility and risk of intestinal bleeding.

Temporary anchorage device usage: a survey among Swiss orthodontists.

BACKGROUND The aim of the survey was to obtain information on the treatment plan preferences, mechanics and characteristics of temporary anchorage device (TAD) application using a single case presented to orthodontists in Switzerland. METHODS A structured questionnaire to be completed by all study participants with case-specific (treatment plan including mechanics and TAD usage) and general questions (general fixed appliance and TAD usage as well as professional, educational and demographic questions) together with an orthodontic borderline case was utilised. The case was a female adult with dental Class II/2, deep bite and maxillary anterior crowing, who had been treated in childhood with extraction of four premolars and fixed appliance followed by wisdom tooth extraction. RESULTS The response rate was 24.4% (108 out of 443). The majority (96.3%, 104) proposed comprehensive treatment, while 3.7% (4) planned only alignment of maxillary teeth. 8.3% (9) included a surgical approach in their treatment plan. An additional 0.9% (1) combined the surgical approach with Class II mechanics. 75.1% (81) decided on distalization on the maxilla using TADs, 7.4% (8) planned various types of Class II appliances and 3.7% (4) combined distalization using TADs or headgear with Class II appliances and surgery. Palatal implants were the most popular choice (70.6%, 60), followed by mini-screws (22.4%, 19) and mini-plates on the infrazygomatic crests (7.0%, 6). The preferred site of TAD insertion showed more variation in sagittal than in transversal dimension, and the median size of mini-screws used was 10.0-mm long (interquartile range (IQR) 2.3 mm) and 2.0-mm wide (IQR 0.3 mm). CONCLUSIONS Distalization against palatal implants and then distalization against mini-screws were the most popular treatment plans. Preferred site for TAD insertion varied depending on type and size but varied more widely in the sagittal than in the transversal dimension.

The use of bougie-guided insertion of a laryngeal mask airway device in neonatal piglets after unexpected complications

After marked airway obstruction with laryngeal mask (LM) placement in neonate piglets, anatomical observations in cadavers revealed a large epiglottis advancing markedly over the soft palate. CT imaging in vivo confirmed that the LM pushes the epiglottis caudally thereby obstructing the larynx. As a new approach, in 20 piglets a flexible PVC bougie placed under laryngoscopy was used to guide the LM to the correct position at the larynx. Placement of the bougie was easy and the LM was positioned successfully in all piglets at first attempt. In 14 piglets, the epiglottis was positioned dorsal to the soft palate before LM insertion and had to be pushed downwards to advance the bougie. In case of failure of LM placement with potential airway obstruction, the use of a bougie to guide the LM over the epiglottis was simple, rapid, and improved the success rate without complication.

[Subcutaneous emphysema following non-surgical peri-implantitis therapy using an air abrasive device: a case report]

Subcutaneous emphysema are rare complications in periodontology. In most cases, they resolve spontaneously. However, air might disperse into deeper facial spaces causing life-threatening complications such as compression of the tracheobronchial tree or the development of pneumomediastinum. Moreover, microorganisms might spread from the oral cavity into deeper spaces. Hence, rapid diagnosis of subcutaneous emphysema is important. Characteristic signs are both a shiftable swelling and a crepitation. In this case report, the case of a 69-year old man with a subcutaneous emphysema immediately after peri-implantitis therapy with the use of a glycine-based powder air-polishing device is described. Following therapy, air accumulated in the left side of the face. Seven days after non-surgical peri-implantitis therapy, the patient was asymptomatic with complete resolution of the emphysema.

Transcatheter mitral valve implantation (TMVI) using the Edwards FORTIS device.

Transcatheter aortic valve implantation (TAVI) has demonstrated the feasibility of treating valvular heart disease with transcatheter therapy. On the back of this success, various transcatheter concepts are being evaluated to treat other valvular disease, especially mitral regurgitation (MR). The concepts currently approved to treat MR replicate surgical mitral valve repair. However, most of them cannot eliminate MR completely. Similar to TAVI, a transcatheter mitral valve implantation may provide a valuable alternative. The FORTIS transcatheter mitral valve (Edwards Lifesciences, Irvine, CA, USA) is a self-expanding device implanted via a transapical approach. We describe our experience and early results in the first five patients treated on compassionate grounds. We also describe the details of the device, selection criteria and technical details of implantation.

Smart Cities – Ein Überblick!

Nach einer kurzen Begriffsfassung von Smart Cities gehen wir basierend auf den folgenden Beiträgen dieses Heftes auf verschiedene Eigenschaften einer solchen smarten Stadt ein. Dadurch versuchen wir den Ist-Zustand dieser Städte zu dokumentieren. Damit die jeweiligen Stakeholder (strategische) Entscheide treffen können, widmen wir danach ein Kapitel den Chancen und Risiken von Smart Cities. Anhand einer Studie des Europäischen Parlaments zeigen wir nachfolgend entsprechende Bestrebungen aus Europa auf. Anschliessend präsentieren wir eine Best-Practice-Roadmap für die Realisierung von Smart Cities. Zum Schluss zeichnen wir auf einer konnektivistischen Lern- und Kognitionstheorie aufbauend einen Weg zur Cognitive City der Zukunft. Dabei wird der Mensch nicht als isoliertes, sondern als vernetztes Individuum gesehen. Dies begünstigt die Weiterentwicklung von Smart Cities zu Städten, welche aktiv und selbstständig lernen und dadurch automatisch auf Veränderungen ihrer Umwelt reagieren können.

Percutaneous management of left atrial appendage perforation during device closure.

A 76-year-old male patient was admitted for percutaneous left atrial appendage (LAA) closure because of chronic atrial fibrillation and a history of gastrointestinal bleeding under oral anticoagulation. The procedure was complicated by perforation of the LAA with the lobe of the closure device being placed in the pericardial space. Keeping access to the pericardial space with the delivery sheath, the LAA closure device was replaced by an atrial septal defect closure device to seal the perforation. Then the initial LAA closure device was reimplanted in a correct position. Needle pericardiocentesis was required but the subsequent course was uneventful.

Transcranial Doppler-guided deairing of a pediatric ventricular assist device: experience with twins

We report the intraoperative courses of 2 consecutive Berlin Heart Excor® Pediatric Ventricular Assist Device implantations, in which transcranial Doppler ultrasonography helped to detect macroscopically undetected residual air bubbles captured in the pump after air removal had been correctly performed according to manufacturer's specifications. Our experience with these cases suggests that a beat-to beat deairing maneuver guided by transcranial Doppler is a useful strategy for reducing cerebral exposure to perioperative gaseous microembolism.

Benefit of a Contralateral Routing of Signal Device for Unilateral Cochlear Implant Users.

Objective: To investigate objective and subjective effects of an adjunctive contralateral routing of signal (CROS) device at the untreated ear in patients with a unilateral cochlear implant (CI). Design: Prospective study of 10 adult experienced unilateral CI users with bilateral severe-to-profound hearing loss. Speech in noise reception (SNR) and sound localization were measured with and without the additional CROS device. SNR was measured by applying speech signals at the untreated/CROS side while noise signals came from the front (S90N0). For S0N90, signal sources were switched. Sound localization was measured in a 12-loudspeaker full circle setup. To evaluate the subjective benefit, patients tried the device for 2 weeks at home, then filled out the abbreviated Speech, Spatial and Qualities of Hearing Scale as well as the Bern benefit in single-sided deafness questionnaires. Results: In the setting S90N0, all patients showed a highly significant SNR improvement when wearing the additional CROS device (mean 6.4 dB, p < 0.001). In the unfavorable setting S0N90, only a minor deterioration of speech understanding was noted (mean -0.66 dB, p = 0.54). Sound localization did not improve substantially with CROS. In the two questionnaires, 12 of 14 items showed an improvement in mean values, but none of them was statistically significant. Conclusion: Patients with unilateral CI benefit from a contralateral CROS device, particularly in a noisy environment, when speech comes from the CROS ear side. © 2014 S. Karger AG, Basel.

Comprehensive measures of sound exposures in cinemas using smart phones

OBJECTIVES Sensorineural hearing loss from sound overexposure has a considerable prevalence. Identification of sound hazards is crucial, as prevention, due to a lack of definitive therapies, is the sole alternative to hearing aids. One subjectively loud, yet little studied, potential sound hazard is movie theaters. This study uses smart phones to evaluate their applicability as a widely available, validated sound pressure level (SPL) meter. Therefore, this study measures sound levels in movie theaters to determine whether sound levels exceed safe occupational noise exposure limits and whether sound levels in movie theaters differ as a function of movie, movie theater, presentation time, and seat location within the theater. DESIGN Six smart phones with an SPL meter software application were calibrated with a precision SPL meter and validated as an SPL meter. Additionally, three different smart phone generations were measured in comparison to an integrating SPL meter. Two different movies, an action movie and a children's movie, were measured six times each in 10 different venues (n = 117). To maximize representativeness, movies were selected focusing on large release productions with probable high attendance. Movie theaters were selected in the San Francisco, CA, area based on whether they screened both chosen movies and to represent the largest variety of theater proprietors. Measurements were analyzed in regard to differences between theaters, location within the theater, movie, as well as presentation time and day as indirect indicator of film attendance. RESULTS The smart phone measurements demonstrated high accuracy and reliability. Overall, sound levels in movie theaters do not exceed safe exposure limits by occupational standards. Sound levels vary significantly across theaters and demonstrated statistically significant higher sound levels and exposures in the action movie compared to the children's movie. Sound levels decrease with distance from the screen. However, no influence on time of day or day of the week as indirect indicator of film attendance could be found. CONCLUSIONS Calibrated smart phones with an appropriate software application as used in this study can be utilized as a validated SPL meter. Because of the wide availability, smart phones in combination with the software application can provide high quantity recreational sound exposure measurements, which can facilitate the identification of potential noise hazards. Sound levels in movie theaters decrease with distance to the screen, but do not exceed safe occupational noise exposure limits. Additionally, there are significant differences in sound levels across movie theaters and movies, but not in presentation time.