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Antireflux surgery has evolved significantly since its inception 50 years ago. The current standard is laparoscopic fundoplication. The computer-assisted telemanipulator, a new device recently approved for use in laparoscopy, reduces some of the shortcomings of the laparoscopic approach. This review specifically discusses the role of this novel surgical tool in antireflux surgery.
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PURPOSE: To provide information concerning the U. S. Food and Drug Administration's (FDA) role as a regulatory agency in the development and safe use of contact lenses. METHODS: The FDA's organizational structure and regulatory classification of medical devices are explained. Specific regulatory authorities are described and examples provided with respect to the FDA's role in the regulation of the new hyper-oxygen permeable continuous wear contact lenses. RESULTS: The application of medical device regulations addresses the rights and safety of subjects in preapproval clinical studies and provides a basis to generate valid scientific evidence to demonstrate the safety and effectiveness of a medical device. Once on the market, there are postmarket requirements with which a manufacturer must comply. CONCLUSION: For continuous wear 30-day lenses, the FDA is using additional regulatory authorities new to the contact lens area to assure that product safety is maintained and consumer information is improved. These include postapproval studies, more informative labeling, and advertising restrictions. Whereas it is the FDA's mission to promote and protect the health of the public by ensuring the safety and effectiveness of medical devices, the agency works in partnership with other stakeholders to maintain the safe use of medical devices.
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PURPOSE: To call attention to the unauthorized sale of cosmetic contact lenses, resulting in ocular complications. DESIGN Observational case report. METHODS: Retrospective, observational, clinical practice setting. RESULTS: Six patients (five female and one male) were seen urgently for acute eye pain and redness after wearing cosmetic plano contact lenses. None of the patients had previously worn a contact lens or spectacle correction. None of the lenses were dispensed by eye care professionals. One patient developed pseudomonal keratitis, ultimately requiring penetrating keratoplasty for visual rehabilitation. CONCLUSIONS: Colored contact lenses are being dispensed without a prescription or fitting from unlicensed vendors, such as cosmetics, convenience, and accessory stores. Lenses are sold individually and without care instructions. Consequently, uninformed lens wearers are experiencing acute, vision-threatening infections and inflammation.
STUDY DESIGN: A prospective, randomized, multicenter, Food and Drug Administration regulated Investigational Device Exemption (IDE) clinical trial. OBJECTIVES: To discern whether there is a correlation between surgical volume and clinical outcomes, as well as the complication rate and perioperative data points, for lumbar total disc replacement. To examine the early experience for lumbar total disc replacement as part of an IDE study. SUMMARY OF BACKGROUND DATA: To our knowledge, an analysis of the effect of surgical volume has not been performed for any spine surgical procedure. Prior reports of the early experience with lumbar total disc replacement consist of retrospective reviews with nonspecific indications. METHODS: An analysis was performed of the Food and Drug Administration IDE Study of the Charité Artificial Disc (DePuy Spine, Inc., Raynham, MA). Patients enrolled in the control group were omitted from the analysis. Up to 5 nonrandomized cases (representing the early experience) were performed at each site before beginning the randomized arm of the study. There were 3 comparisons performed: nonrandomized cases (71) versus randomized cases (205); randomized cases performed by high-enrolling surgeons versus low-enrolling surgeons; and randomized cases at high-volume institutions versus low-volume institutions. RESULTS: The high-enrolling groups had a significantly lower mean hospital stay and operating time compared to the low-enrolling groups (P < 0.05). High-enrolling surgeons and institutions showed significantly shorter operating times, length of hospital stay, and complication rates. High-enrolling surgeons had significantly fewer device failures and cases of neurologic deterioration. Mean operating time and hospital stay were significantly lower in the randomized group (P < 0.05) compared to the nonrandomized group. Blood loss and approach-related complications were similar between the 2 groups. Device failure requiring removal was 4.2% in the nonrandomized group and 1.5% in the randomized group. CONCLUSIONS: Surgeons and institutions with a high volume of lumbar total disc replacement cases have a reduction in key perioperative and postoperative parameters that provide a clinical and/or economic benefit. Surgeons may expect longer hospital stays, higher blood loss, and a higher rate of certain complications in their early experience with total disc replacement procedures, but there was no effect on clinical outcomes.
PURPOSE: To illustrate the implications of the unauthorized sale and unmonitored wearing of decorative cosmetic contact lenses resulting in ocular complications and to determine the prevalence of the use of cosmetic contact lenses obtained from unlicensed providers by adolescents. METHODS: Observational case report, structured interview, and survey in a retrospective, observational, clinical practice setting. Reported sources of contact lenses were categorized as provider and nonprovider, and associations within the data were reviewed by using a Pearson correlation and chi-square test. RESULTS: Twelve patients (eight female and four male) were seen urgently for acute eye pain and redness after wearing plano decorative contact lenses. None of the patients had previously worn a contact lens. None of the lenses were dispensed by eye care professionals. Four patients developed blinding infections requiring hospital admission. Causative organisms included staphylococci, Pseudomonas, and acanthamoeba. One patient required a penetrating keratoplasty. One hundred fifty-nine patients were surveyed. Thirty-seven (23%) used decorative contact lenses. Lenses were obtained from an unlicensed provider 51% of the time. Education about lens care and handling was significantly associated with acquiring lenses from licensed providers (R = 0.74, P < 0.0001). CONCLUSIONS: Colored noncorrective contact lenses are being dispensed without a prescription or fitting from unlicensed vendors. Patients who acquire lenses from unauthorized providers are significantly less likely to be instructed on appropriate lens use and care. Consequently, uninformed lens wearers are experiencing acute vision-threatening infections and inflammation.
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The 51st Annual Meeting of the American Society for Artificial Internal Organs was held in Washington, DC, June 9 to 11, 2005. The abstract submission deadline for this meeting occurred on January 14, 2005. To ensure that the attendees were completely up-to-date with developments in the field of mechanical circulatory support, I was asked to provide a brief summary of developments or milestones that occurred after the abstract submission deadline. The list of highlights included in this manuscript was selected from an informal poll of colleagues and industry representatives, as well as a review of press releases and government- and industry-sponsored Web sites. Any omissions or errors in this summary of the latest developments in the field of mechanical circulatory support are entirely my responsibility. I also want the reader to understand that I have no financial interest in any of the device manufacturing companies to which I will refer.
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The development of sirolimus and paclitaxel-eluting stent delivery systems proved successful in reducing restenosis rates to single digit levels compared to bare metal stents, although the long-term safety of the latter devices was not assessed in these premarket applications. Implantable devices for the treatment of patients with advanced congestive heart failure improved short-term measures of circulatory function but underscored the role of properly conducted randomized controlled clinical trials. All of these examples highlight the critical role of valid scientific evidence in the regulatory process for cardiovascular device development.
Pacemaker (PM) and implantable cardioverter-defibrillator (ICD) therapy are two examples of remarkable technological advances that have revolutionized cardiovascular device therapy. Understanding the history of early PM and ICD device development, recognizing the importance of the clinical data that was required to launch the current "era" of exponential device use, and appreciating the challenge of maintaining device innovation without sacrificing device reliability, are important lessons that may offer insights into future cardiovascular device development.
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All of the risk analysis tables, the risk control measures, verification results, risk/benefit analyses, risk evaluations, and traceability analyses need to be documented and available for inspection by auditors. One way to organize this documentation is to have a risk management file that includes or references each of these documents.