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Shedding light on lasers.
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Food and Drug Administration control of medical devices: an inescapable intrusion and stimulus for adaptation.
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E-mail, snail mail, phone, or fax. Reporting adverse reactions and other product problems.
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[Labcor-stented porcine heart valve prosthesis in laboratory testing in accordance with prEN 12006-1].
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FDA medical device regulation and informed consent.
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Standards in the European regulatory process.
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Dentist-prescribed home bleaching: current status.
White teeth have been an indicator of physical attractiveness throughout history. Only recently have we been able to whiten teeth with few side effects, making tooth bleaching a popular and effective dental treatment. The American Dental Association (ADA) has established guidelines on safety and effectiveness for tooth bleaching. External stains from aging or inherent dark color are more responsive to bleaching than internal stains. Dentist-prescribed home bleaching--including a careful dental exam, custom-fabricated trays, tacky high-viscosity gels, adequate instructions, and recall exams--has been shown to be an effective method for bleaching teeth. Trays can be worn overnight or during the day with similar effectiveness. The bleaching effect can last up to 3 years with more than 50% success.
Orthopedic devices; effective data of requirement for premarket approval for hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis. Final rule.
The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis. The agency also is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. This action implements certain statutory requirements.
Catheter closure of atrial septal defects.
Following the pioneering work of King, Rashkind and their associates in the mid 1970s, a number of devices have been designed and tested in animal models and human subjects. Some devices have been discontinued and others were modified followed by further clinical trials. At the time of this writing, only one device, ASO, was approved by the FDA for general clinical use to occlude atrial defects. There are a number of other devices which are in clinical trials, including the CardioSeal/StarFlex, COD buttoned, Helex and transcatheter patch devices. The preceding paper reports on the utility of ASO in occluding atrial defects in adult patients: the results appear good with extremely rare major complication and little need re-intervention during follow-up. It is envisioned that several other devices will be approved by the regulatory authorities in the foreseeable future so that an appropriate device for a given type of atrial septal defect may be selected by the practicing interventional cardiologist.
Food and Drug Administration regulation of orthotic cranioplasty.
OBJECTIVE: To present information regarding the current federal regulation of cranial orthotics used for the treatment of deformational plagiocephaly as well as to discuss concerns raised by the Food and Drug Administration regarding the safety and effectiveness of these devices. BACKGROUND: Although first introduced in 1979, the use of orthotic helmets for the treatment of deformational plagiocephaly was slow to gain acceptance. However, with the recent increase in infants presenting with this condition, numerous orthotic treatment programs have been established throughout the country. Until recently, federal regulation of this "industry" was largely ignored. REGULATION: In 1995 our office was served notice that our orthosis would require clearance from the FDA. Since the FDA had never approved a medical device of this kind, clearance presented a significant challenge. However, after 3 years of providing clinical data, clearance was finally granted, and a new device category known generically as "cranial orthosis" was created. A cranial orthosis is considered to be a Class II neurology device and requires both general and special controls in order to ensure its safety and effectiveness. SUMMARY: Orthotics used for the treatment of deformational plagiocephaly are regulated by the FDA and are considered Class II neurology devices. Submission of a premarket notification (510[k]) is required prior to placing these devices on the market.
Medical devices containing materials derived from animal sources (except for in vitro diagnostic devices), guidance for FDA reviewers and industry; availability--FDA. Notice.
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Medical Devices Containing Materials Derived From Animal Sources (Except for In Vitro Diagnostic Devices), Guidance for FDA Reviewers and Industry." This guidance is intended to provide recommendations for information that is to be included in premarket submissions--investigational device exemption (IDE), premarket approval application (PMA), and 510(k) submissions for medical devices that either contain or are exposed to animal-derived materials during manufacturing.
Endovascular abdominal aortic aneurysm (AAA) repair since the FDA approval. Are we going too far?
BACKGROUND: Since the FDA approval of endovascular devices for abdominal aortic aneurysm (AAA) repair, clinicians have been relaxing the strict inclusion criteria of the clinical trials. We have reviewed our experience during and after the clinical trials to examine changes in patient selection, technical aspects of the procedure, and outcome. METHODS: A review of a prospectively compiled database of all endovascular AAA repairs performed at our institution was performed. RESULTS: Endovascular AAA repair was attempted in 130 patients: 46 (35.4%) as a part of clinical trials (Group I), and 84 (64.6%) since the FDA approval of the devices (Group II). Significant differences in patient selection included: a higher proportion of short (<15 mm) proximal necks in Group II (28.6 vs 0.0%, p<0.001), and a higher proportion of iliac occlusive disease in Group II (48.8 vs 15.4%, p=0.001). Additional trends suggested that Group II AAA's were more complex, including increased proximal neck angulation, increased proximal calcification, increased presence of proximal thrombus, and increased iliac tortuosity. Significant differences in technical aspects of the procedure included increased usage of iliac angioplasty (46.4 vs 13.3%, p<0.001), iliac stenting (31 vs 8.9%, p<0.01), and conduit access to the external iliac artery (10.7 vs 0%, p=0.03) in Group II. Analysis of outcome revealed a decreased incidence of the following in Group II cases: conversions to open repair (2.4 vs 10.9%), lower extremity ischemia (3.6 vs 13.0%), and graft limb occlusion (2.4 vs 8.7%). Other major perioperative complications did not differ significantly between the 2 groups. However, although the overall rate of any endoleak noted in the postoperative course was decreased in Group II cases (26.2 vs 32.6%), the incidence of proximal or distal attachment site leaks has increased (11.9 vs 4.3%, p=0.14). Although this comparison did not reach statistical significance, the magnitude of the increase is concerning. CONCLUSIONS: Although we have been able to offer endovascular AAA repair to a larger number of patients since FDA approval, endovascular management of increasingly complex proximal necks and increased iliac artery disease appears to have increased the incidence of attachment site endoleaks. Although many of these leaks have been successfully managed with adjunctive endovascular procedures, their increasing incidence is worrisome and suggests that we may need to re-evaluate current inclusion criteria for using this technology. Although difficult access issues have been handled with adjunctive procedures, the presence of a short, angulated proximal neck may be difficult to overcome, and may not be well suited for endovascular repair with the currently available devices.
EU and member state medical devices regulation.
This article examines European Union (EU) and member state regulation of medical devices, particularly: a) the similarities and differences between medical devices and prescription drugs, including the respective industries, market authorization pathways, and boundary issues between the two sectors; b) the political background, current nature, and future prospects for EU medical device regulation; and c) regulatory responsibilities of the member states. Included are definitions of medical devices and in vitro diagnostics, and a brief history of their treatment by European law. The erosion of boundaries between exclusive and shared responsibilities of the EU and member states will be addressed, especially as it affects market approval of medical devices, clinical investigations, labeling and instructions for use, price setting and reimbursement, and evidence-based medicine and healthcare technology assessment. Finally, the article discusses medical device reporting and surveillance systems, which may be the weakest link in the EU integrative process. If patient safety is as important to the EU regulatory scheme as free movement and competitiveness, then both Brussels and member states will require additional resources, as well as measures to overcome obstacles to implementation, evaluation, and accountability.
The current status of therapeutic apheresis devices in the United States.
Over the last 40 years, plasmapheresis technology and its indications for use have been continually evolving. With the growing incidence for autoimmune diseases, unsatisfactory therapeutic options, side effects of drug therapy, and economic relevance, apheresis clinicians have been leaning toward more selective plasmapheresis techniques through the use of plasma fractionators and immunoadsorption columns. Plasma fractionators are mostly used in Asia, and rarely utilized in the U.S. The majority of plasma filters approved by the Food and Drug Administration (FDA) are primary membrane plasma separators, which still require replacement fluid. The secondary plasma fractionators available in the U.S. are limited in used and mostly investigational. Immunoadsorption columns, mostly used in Europe, are gaining popularity in the U.S. Some FDA-approved immunoadsorption columns include the Prosorba protein-A silica column, Immunosorba tryptophan and phenylalanine columns, Immunosorba protein-A sepharose column, and Liposorber dextran sulfate column. In addition, the heparin-induce extracorporeal lipoprotein precipitation (HELP) system is also FDA-approved. However, there are other immunoadsorption technologies used in Europe, such as direct adsorption lipoprotein LDL-hemoperfusion, not yet available in the U.S. While each method of apheresis carries its own risks and benefits, it is the opinion of the authors that these additional apheresis techniques be available to U.S. researchers and clinicians as a therapeutic option. The authors believe that the U.S. need to aggressively investigate more specific plasmapheresis modalities and establish appropriate dialogue with regulatory and reimbursement officials for FDA-approval of these devices.
Warning! OSHA is zeroing in on regs for needlestick injury: how to comply.
You might be out of compliance with a directive from OSHA, which instructs inspectors to cite hospitals for failure to evaluate and purchase safer needle devices. You are at risk for fines of $7,000 for serious violations and $70,000 for willful violations if you aren't evaluating and purchasing safer needle devices. A new federal law requires the use of safer devices, and that employers solicit input on new devices from employees. More than 250 federally approved safer needle devices are available. Designate senior employees to train less experienced staff when new devices are used.
Endovascular stent graft selection for the treatment of abdominal aortic aneurysms.
Minimally invasive endovascular techniques for the treatment of abdominal aortic aneurysms (AAA) have significantly reduced the morbidity of these procedures as compared with standard surgical repair. In addition, patients with extensive comorbid medical illnesses in whom standard operative repair is contra-indicated, may be successfully treated using endovascular means. A variety of endovascular stent grafts are currently being used clinically for endovascular AAA repair. The characteristics of these stent grafts vary significantly. In selecting the specific stent graft to be used for endovascular AAA repair, these specific characteristics must be considered particularly with regard to the individual patient's anatomic and physiologic characteristics. The United States Food and Drug Administration (FDA) has approved 4 endovascular stent grafts for the treatment of AAA: the Medtronic AneuRx, the W. L. Gore Excluder, the Cook Zenith and the Guidant Ancure. The Zenith graft received approval for marketing in 2003 and has gained relatively wide usage, in part due to its ability to treat aneurysms with relatively large diameter implantations zones. Also in 2003 the Guidant Corporation withdrew the Ancure graft from marketing and distribution. Enrollment has also been recently completed for the phase II FDA trials of the Medtronic Talent graft and the Cordis Fortron graft. These devices have been approved for use in the European Union and are awaiting FDA panel meeting in the United States. Comparative analysis of several of the available stent grafts has been performed. Results have varied with regard to the need for secondary interventions, aneurysm sac size reduction and the occurrence of continued perfusion of the aneurysm sac. Several significant advances have also occurred recently in stent graft research and development. Of particular significance has been the initiation of the phase I trial of the Trivascular Enovus graft. Deployment of the Trivascular graft may be accomplished through a delivery system that is considerably reduced in profile. The potential for percutaneous application of the graft may be available in the future. The indications for use of endovascular grafts as compared to standard open surgery have not yet been fully defined. Endovascular stent grafts in current use have limitations and their use must be tempered accordingly, until their long-term effectiveness is more completely evaluated. This article describes the general principles of use for endovascular devices for the repair of AAAs. It details the features and results for the devices in current use and highlights the factors that influence the selection of specific stent graft types.
An overview of Food and Drug Administration regulation of drugs, biologics, and devices to be used for management of periodontal diseases.
The Food and Drug Administration (FDA) has been actively involved in assuring the safety and effectiveness of medical products since 1906. The FDA was granted increased authority to regulate drugs in 1938 and devices in 1976. The regulatory requirements for marketing in the United States vary according to the type of product and the degree of risk associated with it. One route to the market is through the premarket notification [510(kappa)] process in which devices are evaluated according to their substantial equivalence to devices marketed prior to May 28, 1976. Many devices specifically intended to treat periodontal conditions have progressed through the 510(kappa) process based on their substantial equivalence to predicate devices. In some cases manufacturers have needed to provide clinical data in the form of Investigational Device Exemptions (IDE) to support an equivalence determination. Certain devices with indications for use in periodontal evaluation or therapy, specifically, those determined by FDA to be not substantially equivalent to legally marketed devices, require Premarket Approval Applications (PMA). For new drug products, clinical trials are carried out under an approved Investigational New Drug Application (IND). Application for approval for marketing is requested through a New Drug Application. Data from clinical trials conducted outside the United States may be considered by the FDA in support of the safety and effectiveness of the product. The FDA is continually developing and updating guidance documents and guidelines to assist manufacturers in gaining clearance/approval to market new products.