Ensuring safe and effective medical devices.
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Laparoscopic tubal electrocoagulation continues to be widely practiced; however, mechanical devices such as the Yoon band, the Hulka clip, and, most recently, the Filshie clip are becoming more popular because of the avoidance of accidental electrical burns, the diminished likelihood of subsequent ectopic pregnancy, and, in the case of the clips, the minimal degree of tubal destruction, thus allowing for maximum reversibility. This survey of worldwide reports from 1981 to the present reveals a high level of acceptance of the Filshie clip because of its effective design and ease of application.
Growing demands to contain health care's inflationary expenditures have particular relevance for elective (eg, orthodontic) services, because their progressively increasing provision will ultimately jeopardize the resources for others (eg, restorative dentistry). Some form of rationalization is therefore inevitable, especially in services eligible for payments from third-party benefits. These are central concerns of the ongoing debate on whether rationalization should be driven by service efficiency and cost efficiency and who should make such decisions. The adaptation of contemporary computer-based technology could resolve this dilemma, especially if real-time comprehensive assessments of 3-dimensional craniofacial forms before and after treatment are incorporated into local and national databases. Such a facility would then help to develop clinical guidelines to optimize the provision of specific orthodontic services for particular malocclusions. Referring individual cases to these databases would subsequently help to control service expenditures and maintain or even improve their outcomes to the ultimate benefit of both the profession and the public.
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The American Dental Association has approved several devices as aids in the diagnosis of temporomandibular disorders. Concerns remain, however, about their safety and effectiveness. This article reviews the validity and use of several instruments that claim to serve as aids in the detection of masticatory muscle pain, trismus, joint noises, and limitation of jaw motion. A review of data from 62 published articles indicated that, although commercial devices that measure jaw muscle tenderness, muscle activity levels, joint noises, and jaw motion are safe and can document these phenomena, cost-benefit analyses of these devices have not yet been conducted. Moreover, these devices have not been shown to have stand-alone diagnostic value and, when tested, they have demonstrated unacceptable sensitivity and specificity levels. None of the instruments reviewed in this article can be said to provide more than ancillary documentation.
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BACKGROUND: Since their introduction into clinical trials in the United States, endovascular aortic grafts have shown various types of problems. Although details of design and construction vary between different endovascular grafts and failure modes have had a variety of causes and clinical effects, the inability of preclinical testing to predict these failures remains common to all endovascular grafts. The need to improve preclinical testing in an attempt to reduce clinical device failures resulted in a Food and Drug Administration-sponsored workshop on endovascular graft preclinical testing held in Rockville, Md, from July 31 to August 1, 2001. FORMAT: The workshop was not designed as a consensus conference. Instead, it provided a forum for bringing stakeholders together to define problems and identify areas of agreement and disagreement. The workshop had 34 invited participants who represented device manufacturers, the medical community, the Food and Drug Administration, and testing facilities, and international attendance was more than 120 people. OUTCOME: Discussion centered on: 1, defining the physiologic, anatomic, and morphologic characteristics of abdominal aortic aneurysms before and after endovascular graft treatment; 2, identifying the types of failures that have been observed clinically; and 3, determining which characteristics should be considered during preclinical modeling to better predict clinical performance. Attendees agreed to the need to better define and address anatomic characteristics and changes in the aneurysm after endograft treatment to optimize preclinical testing. Much discussion and little agreement occurred on the importance of flow-related forces on graft performance or the need or ability to define and model physiologic compliance during durability testing. The discussion and conclusions are summarized in this paper and are provided in detail at: http://www.fda.gov/cdrh/meetings/073101workshop.html. CONCLUSION: The workshop raised awareness of significant performance issues and the challenges of modeling the extremely variable and relatively undefined environment of abdominal aortic aneurysms. Through the interactive format of the workshop, participants identified areas of preclinical testing, device design, and aspects of the simulated environment that need further consideration.
Traffic-related injuries have become a major public health concern worldwide. However, unlike developed or high-income countries (HICs), many developing or low-income countries (LICs) have made very little progress towards addressing this problem. Lack of the progress in LICs is attributable, in part, to their economic situation in terms of their governments' lack of resources to invest in traffic safety, cultural beliefs regarding the fatalism of injuries, competing health problems particularly with the emergence of HIV/AIDS, distinctive traffic mixes comprising a substantial number of vulnerable road users for whom less research has been done, low literacy rates precluding motorists to read and understand road signs, and peculiar political situations occasionally predominated by dictatorship and non-democratic governments. How then can LICs tackle the challenge of traffic safety from the experiences of HICs without reinventing the wheel? This paper reviews selected interventions and strategies that have been developed to counter traffic-related injuries in HICs in terms of their effectiveness and their applicability to LICs. Proven and promising interventions or strategies such as seat belt and helmet use, legislation and enforcement of seat belt use, sidewalks, roadway barriers, selected traffic-calming designs (e.g., speed ramps/bumps), pedestrian crossing signs combined with clearly marked crosswalks, and public education and behavior modification targeted at motorists are all feasible and useable in LICs as evidenced by data from many LICs. While numerous traffic-related injury policy interventions and strategies developed largely in HICs are potentially transferable to LICs, it is important to consider country-specific factors such as costs, feasibility, sustainability, and barriers, all of which must be factored into the assessment of effectiveness in specific LIC settings. Almost all interventions and strategies that have been proven effective in HICs will need to be evaluated in LICs and particular attention paid to the effectiveness of enforcement measures. It behooves LIC governments, however, to ensure that only standard, approved safety devices like helmets are imported into their countries. Additionally, LICs may need to improvise and innovate in the traffic safety technology transfer.
Breast implants have been used for about four decades for both reconstructive and aesthetic purposes. In 1963, the quality of the artificial implants was revolutionized by the introduction of the silicone gel-filled implant. Since, this modern prosthesis has gone through an evolution of change and improvement with several types of devices with many variations and styles within each class. Actually, for the last three decades, approximately one million women have received silicone breast implants in the USA. But, in 1992, the American FDA banned silicone from the market, leaving saline implants as the only product generally available as an alternative until now. Other filler materials were introduced, but have never progressed beyond the experimental stage in the USA (in contrast with Europe). The evolution of the different implants through time, with their advantages and disadvantages will be discussed, but also the controversy on silicone implants in the USA and their suspected association with systemic diseases.
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