Bottom trawl catch comparison in the Mediterranean Sea: Flexible Turtle Excluder Device (TED) vs traditional gear.

The Mediterranean Sea is a biodiversity hotspot where intense fishing pressure is associated with high bycatch rates of protected species (sea turtles and cetaceans) and top predators (sharks). Since the conservation of these species has become a priority, fishery scientists are faced with the challenge of reducing incidental catch, which entails high rates of mortality. Among the species threatened by fishing activities, the loggerhead turtle (Caretta caretta) is a charismatic species considered as "vulnerable" at the global scale. In the Mediterranean Sea trawl nets are the gears with the highest probability of catching protected species incidentally. A new flexible Turtle Excluder Device (TED) was tested for the first time on commercial bottom trawlers to assess its effectiveness in reducing bycatch in the Mediterranean Sea. Analysis of the total catches of the hauls made with and without the TED showed that the difference in terms of weight was not significant. The catch of the main commercial species showed similar rates without a significant loss of size (i.e. total length) with the exception of the largest anglerfish (Lophius spp.). The bycatch of control nets included mostly rays and sharks, but never turtles, although the authors learned from the crews of other vessels operating in the same areas at the time of the trials that they had caught some loggerhead turtles. Our study demonstrates that TED scan be adopted without significantly affecting commercial catch. This informs fishers and managers for a practical and effective means that may reduce the bycatch of threatened species in coastal Mediterranean demersal multispecies fisheries. The measures involving gear modifications require significant investment but they are technically feasible and are capable of improving the conservation prospects of these endangered species. Besides ensuring normal earnings, the TED induced a significant reduction of debris and litter in the codend, thus reducing catch sorting time and improving catch quality.

Quality of Deaf and Hard-of-Hearing Mobile Apps: Evaluation Using the Mobile App Rating Scale (MARS) With Additional Criteria From a Content Expert.

BACKGROUND: The spread of technology and dissemination of knowledge across the World Wide Web has prompted the development of apps for American Sign Language (ASL) translation, interpretation, and syntax recognition. There is limited literature regarding the quality, effectiveness, and appropriateness of mobile health (mHealth) apps for the deaf and hard-of-hearing (DHOH) that pose to aid the DHOH in their everyday communication and activities. Other than the star-rating system with minimal comments regarding quality, the evaluation metrics used to rate mobile apps are commonly subjective. OBJECTIVE: This study aimed to evaluate the quality and effectiveness of DHOH apps using a standardized scale. In addition, it also aimed to identify content-specific criteria to improve the evaluation process by using a content expert, and to use the content expert to more accurately evaluate apps and features supporting the DHOH. METHODS: A list of potential apps for evaluation was generated after a preliminary screening for apps related to the DHOH. Inclusion and exclusion criteria were developed to refine the master list of apps. The study modified a standardized rating scale with additional content-specific criteria applicable to the DHOH population for app evaluation. This was accomplished by including a DHOH content expert in the design of content-specific criteria. RESULTS: The results indicate a clear distinction in Mobile App Rating Scale (MARS) scores among apps within the study's three app categories: ASL translators (highest score=3.72), speech-to-text (highest score=3.6), and hard-of-hearing assistants (highest score=3.90). Of the 217 apps obtained from the search criteria, 21 apps met the inclusion and exclusion criteria. Furthermore, the limited consideration for measures specific to the target population along with a high app turnover rate suggests opportunities for improved app effectiveness and evaluation. CONCLUSIONS: As more mHealth apps enter the market for the DHOH population, more criteria-based evaluation is needed to ensure the safety and appropriateness of the apps for the intended users. Evaluation of population-specific mHealth apps can benefit from content-specific measurement criteria developed by a content expert in the field.

Are We Cutting Ourselves Short? Laser Lithotripsy Performance Based on Differences in Fiber-tip Preparation.

OBJECTIVE: To better understand the impact of laser fiber-tip configuration on lithotripsy performance, we undertook an in vitro study comparing 3 fiber-tip configurations: (1) new (single-use), (2) cleaved (reusable), and (3) coated (cut with scissors). METHODS: Lithotripsy was performed using a Ho:YAG laser utilizing fragmentation (1 J × 10 Hz) and dusting (0.5 J × 20 Hz) settings. BegoStones were fragmented with a laser fiber advancing at a speed of 1 mm/s (220 seconds of activation). Three fiber-tip configurations were tested: new single-use standard (242 µm core) and cleaved (272 µm core), compared to the same fiber-tip coated/cut flush with scissors, respectively. Study outcome was difference in stone mass before and after each experiment. Power output was measured using a power meter. RESULTS: Fragmentation for new or cleaved fibers was greater than the coated/cut flush fiber-tip (P <.05). For 1 J × 10 Hz and 0.5 J × 20 Hz settings, fragmentation was 59% and 75% higher with new fiber-tip compared to the coated/cut flush fiber-tip, respectively. For 1J × 10 Hz and 0.5 J × 20 Hz settings, fragmentation was 51% and 45% higher with cleaved fiber-tip compared to the coated/cut flush fiber-tip, respectively. Power output at the end of laser activation was higher for new and cleaved fiber-tips. CONCLUSION: New and cleaved laser fibers demonstrated superior lithotripsy performance compared to fibers that were coated/cut flush with scissors. Cutting single-use laser fibers risks damaging the fiber-tip which can disperse the energy and reduce lithotripsy efficiency.

Making sense of the food and drug administration.

An examination of and recommendations regarding the approval process for medical devices are presented. The typical pathways and hurdles laid out by the Federal Food and Drug Administration (FDA) are discussed, and options for marketing and use of medical devices are addressed. The first step in the regulatory process is to establish that the new product is, in fact, a medical device. From there, the appropriate classification and the corresponding level of regulatory control that will be required can be identified. The appropriate marketing application will be submitted and is supported by the data necessary to reasonably assure safety and effectiveness. Once the application is submitted, reviewed, and eventually approved, the manufacturer may legally market and sell the medical device. The active involvement of physicians as advisors and innovators in medical device development is imperative to the successful development of safe and effective medical devices. Physicians also fulfill the important obligation of adverse event reporting with all medical devices that they use. The pediatric physician should additionally be aware of the FDA regulations and expectations with respect to devices that will serve pediatric patient populations, of the regulatory options for approval and unapproved use for some devices, and of the special measures taken to protect the rights, safety, and welfare of pediatric patients participating in investigational studies.

A close look at closure devices.

This paper will deal with the use of arterial closure devices after endovascular procedures. An overview of the currently available devices will be given. Indications and contraindications for their use, results and complications will be described.

Cerebral monitoring devices: what we pay for.

In this review paper, the authors analyse advantages, pitfalls and economical considerations related to depth of anaesthesia monitoring. They first describe the most widely distributed monitors in Europe, and the physiological basis of each index. The optimal use of those monitors and their demonstrated clinical benefits are detailed, as well as the circumstances that can lead to erroneous information or interpretation. Knowledge of patients and practitioners, as well as beliefs and expectations regarding depth of anaesthesia monitoring are discussed. Finally, the authors give their own opinion regarding the use of depth of anaesthesia monitoring, according to clinical benefit and economical considerations.

Scale of protection and the various types of sports mouthguard.

OBJECTIVES: To present a grading system of the protection offered by various types of mouthguard, together with an indication of associated risks, in order to make athletes aware of the consequences of improper or no mouth protection. METHODS: A review of the literature on mouthguards, mouthguard materials, and novel laminates for mouthguards was carried out as it was apparent that information on mouthguards was lacking. Studies on stock (or unfitted) mouthguards, mouth formed (boil and bite) mouthguards, and custom mouthguards are reviewed. RESULTS: A scale of protection offered by various mouthguards and novel laminates has been produced, where 0 indicates no mouthguard and 10 indicates a custom made mouthguard offering excellent protection. CONCLUSIONS: From work carried out on laminates and the manufacturing processes of mouthguards, it became apparent that information was lacking to enable athletes make informed decisions about the best oral protection for their chosen sport.

Shoe design for prevention of injuries in sport climbing.

Foot injuries and deformations are more frequent at higher levels of sport climbing. These are accepted as unavoidable because it is assumed that, for optimal performance, a prerequisite is the wearing of a shoe, which is too tight and has an unnatural shape. Based on a biomechanical analysis, we came up with a different approach to shoe design. By using regional thinning of the sole, easy flexion and extension of the toes is made possible. The form of the shoe conforms to the natural form of the foot, the shoe closure provides a close fit for feet with width differences of up to 20 mm and a shoe-sizing system was developed. After testing prototypes, we conclude that the new shoe design can contribute to the prevention of foot injuries and deformations in sport climbing.

Dental devices; classification for intraoral devices for snoring and/or obstructive sleep apnea. Final rule.

The Food and Drug Administration (FDA) is classifying the intraoral devices for snoring and/or obstructive sleep apnea into class II (special controls). These devices are used to control or treat simple snoring and/or obstructive sleep apnea. This classification is based on the recommendations of the Dental Devices Panel (the Panel), and is being taken to establish sufficient regulatory controls that will provide reasonable assurance of the safety and effectiveness of these devices. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of the guidance document that will serve as the special control for this final rule.

Medical devices; general hospital and personal use devices; classification of implantable radiofrequency transponder system for patient identification and health information. Final rule.

The Food and Drug Administration (FDA) is classifying the implantable radiofrequency transponder system for patient identification and health information into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.

Medical devices; clinical chemistry and clinical toxicology devices; classification of newborn screening test systems for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry. Final rule.

The Food and Drug Administration (FDA) is classifying newborn screening test systems for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Newborn Screening Test Systems for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, the Food and Drug Administration Modernization Act of 1997, and the Medical Device User Fee and Modernization Act of 2002. The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.

Observations on medical device design, Part I: Current practice.

Medical devices must be designed and proven to be fit for the purpose that they were intended. Good design practice ensures this fitness for purpose and is reflected in the commercial success of products. This two-part article focuses on current industry design practice and proposes that there are significant benefits to be obtained by defining good design practice: better products and reduced development costs.

Uses of ultrasonic instrumentation in endodontics.

Ultrasonic instrumentation has added a new horizon to endodontic treatment possibilities. It is a tool in the arsenal of instruments currently used by almost every endodontist in the United States. The use of ultrasonic instrumentation was formerly confined solely to periodontics, but has slowly come to be an indispensable tool in endodontics as well.

Comparison of in vivo longitudinal strength and conformability following stent implantation in rabbit iliac artery.

OBJECTIVES: The aim of this study was to determine the in vivo longitudinal strength and conformability of various stent platforms following stent implantation in rabbit iliac arteries. BACKGROUND: Recently, longitudinal coronary stent deformation has been highlighted and bench tests have demonstrated differences in longitudinal strength among various stent platforms. However, this has not been investigated in an in vivo setting. This is of interest because there may be a trade-off between longitudinal strength and conformability. METHODS: We evaluated 4 types of commercially available stents: Multi-Link 8 (Abbott Vascular); Omega (Boston Scientific); Integrity (Medtronic); and Nobori (Terumo Corporation). To investigate the longitudinal strength, constant axial force was applied to the stent edge by a guiding catheter after deployment in a rabbit iliac artery. The amount of longitudinal stent deformation was calculated by measuring stent length. In order to evaluate conformability, stents were deployed crossing over the iliac bifurcation and the bifurcation angles were measured before and after stent implantation. If the change in the angle was small, the stent was considered to be more conformable. RESULTS: The Omega stent demonstrated significantly greater longitudinal compression compared with other stents (Omega, 17.4 ± 9.3%; Multi-Link 8, 2.8 ± 2.3%; Integrity, 2.8 ± 1.4%; Nobori, 3.8 ± 3.2%; P=.01), but Omega showed better conformability, as evidenced by the smallest percent change in the bifurcation angle (Omega, 12.7 ± 0.8%; Multi-Link 8, 25.7 ± 2.4%; Integrity, 28.3 ± 1.1%; Nobori, 28.1 ± 6.8%; P=.03). CONCLUSION: In this rabbit model, the Omega stent, which has the platform of the Element stent, showed less longitudinal strength but greater conformability compared with the other stent platforms.

[Implementation of a scale on stone baskets]. / Implementierung einer Skala auf Steinfangkörben.

BACKGROUND: Complications after endoscopic retrieval of kidney and ureter stones are obviously related to the size of the stones as well as the experience of the surgeon and other factors. During the procedure it is sometimes difficult for surgeons to estimate stone size and therefore give prognostic advises. The visual perception of the stone size depends on the shape, colour, distance to the renoscope and dilatation of the ureter. This is the so-called binding problem, because shape, color and direction of motion are processed separately by different population of optical neurons. In order to establish a better prognostic ratio, especially for less experienced surgeons we established an intraoperative semi-quantitative measurement of the stone size supported by a stone basket. MATERIALS AND METHODS: We modified the tipped nitinol stone baskets from the company Urotech with diameters of 2.5, 3.0 and 4 Ch. The handle of this basket has a spring mechanism, which automatically closes the basket and provides a predefined fixation force of the stones within the basket. On the handle we established a non-linear scale in mm by grabbing standardized balls or standardized screws. RESULTS: The scales are nonlinear because of the nonlinear relation between the diameter of the stone and the distance of the slider. Also the scales differ in between the basket size, because of the different strain conditions due to the different wire sizes and materials or the spring and basket. CONCLUSIONS: This scale could be an important orientation for a surgeon during endourological procedures to estimate stone sizes. It could be used also for the documentation of the size of fragments after an endourologic lithotripsy and could help in the decision for or against an extraction. Finally it could be very interesting for other disciplines like gastroenterology. The scale should be validated in further clinical trials.

Electroconvulsive therapy device classification: response to FDA advisory panel hearing and recommendations.

Electroconvulsive therapy (ECT) is a safe and highly effective treatment for management of acute episodes of a variety of serious mental disorders, particularly for major depressive episodes that are resistant to multiple interventions with treatment alternatives. As such, the National Network of Depression Centers (NNDC), a consortium of major academic centers with interest and expertise in this area, believes there is an important public health need for ECT to remain available for clinical use. As with all medical devices, ECT is regulated by the US Food and Drug Administration (FDA), which is presently involved in formulating a proposed rule as to how such devices should be classified. Since such classification may have substantial effects on the availability of ECT to patients for whom it is clinically indicated, the NNDC has reviewed the information provided by the FDA to its Advisory Panel, as well as the subsequent deliberations of the Panel itself at a January 2011 public hearing. This review indicates that the FDA may have substantially underestimated the efficacy of ECT as a means to produce large clinical improvements for individuals suffering from severe major depressive disorders and that such an underestimate likely affected the Panel's willingness to recommend reclassification of ECT devices to a less restrictive category. In addition, the NNDC's review generates support for a variety of methods by which the safety of ECT can be ensured, which is an essential requirement for such reclassification.

Critical assessment of new devices.

Medical devices are one of the most highly regulated products in the world. Despite this, there is an unacceptable rate of medical error. Not solely due to the device, but also the user and/or system in which it is used. The current approach to testing of medical devices must be progressed so the concept of user beware is changed to user be aware. All health professionals should be well informed as to the various aspects of each new device. Also, testing in research facilities that are equipped with qualified personnel and the proper testing methods should be supported. The outcome of good research then can be translated into good practice. This implementation requires constant communication for quality improvements from and to professional committees, educational leaders, and experts in the field. Medical devices are thoroughly tested before they are marketed, but we, as clinicians and users, must continuously examine and improve the design of equipment, procedures, personnel, and the environment in which we work to optimize medical systems. Once the device is on the market, changes or modifications are costly. Finally, a factor for success in critical testing of new devices is not what is technically possible, but rather making a concrete contribution to improving medical problems.