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PubMed1998

Regulatory perspective on characterization and testing of orthopedic bone cements.

This paper provides a general regulatory background of acrylic bone cements, chemical composition information on several commercially available bone cements, physical and chemical methods of analyses, mechanical test methods, and risks and failure mechanisms of acrylic bone cements. Suggestions and recommendations presented in Tables 2 and 3 are not mandatory requirements but reflect data and methodologies which the FDA's Orthopedic Devices Branch (ORDB) believes to be acceptable to evaluate most pre-clinical data. FDA may require information in addition to that contained in this paper. In some instances, a sponsor may be able to sufficiently justify the omission of some tests. Although this paper describes certain administrative requirements, it does not take the place of the requirements contained in Title 21 of the Code of Federal Regulations (21 CFR) Parts 801, 807, 812, and 814 or those found in the statute.

Animals↗
PubMed2003

Regulating the economic evaluation of pharmaceuticals and medical devices: a European perspective.

Throughout the developed world, economic evaluation of costly new pharmaceuticals and medical devices became increasingly widespread and systematic during the 1990s. However, serious concerns remain about the validity and relevance of this economic evidence, and about the transparency and accountability of its use in public sector reimbursement decisions. In this article, we summarise current concerns in Europe, based on interviews with European health economists from industry, universities, research institutes and consulting firms. We identify five challenges for European policy-makers, and conclude that there is considerable scope for improving decision-making without damaging incentives to innovate. The challenges are: (1). full publication of the economic evidence used in reimbursement decisions; (2). the redesign of licensing laws to improve the relevance of economic data available at product launch; (3). harmonisation of economic evaluation methodologies; (4). development of methodologies for evaluation of health inequality impacts; and (5). negotiation of price-performance deals to facilitate the use of economic evidence in post-launch pricing review decisions, as information is gathered from studies of product performance in routine use.

Clinical Trials as Topic↗
PubMed1999

Regulation of health-related technologies in Germany.

Against the background of a financial crisis and supposed inefficiencies due to inappropriate use or the use of ineffective technologies in the German health care system, increasing awareness of the role of coverage decisions and the use of health technologies has stimulated interest in the regulation of health technologies. A systematic analysis of the decision processes at the levels of licensing/market admission, coverage by statutory health insurance and steering of diffusion and usage reveals considerable inconsistencies in different health care sectors. With regard to different types of technology, an explicit licensing procedure conforming to international standards is required for drugs and medical devices. Concerning coverage decisions, the ambulatory sector appears to be much more regulated than the in-hospital sector. This applies also to diffusion and usage of technologies. However, steering of usage of health related technologies is generally weak in Germany since only non-binding guidelines are in place.

Delivery of Health Care↗
PubMed2001

Collamer intraocular lens: clinical results from the US FDA core study.

PURPOSE: To assess the safety and efficacy of the Staar Collamer intraocular lens (IOL) 1 year postoperatively. SETTING: Fifteen private ophthalmology practices geographically distributed throughout the United States. METHODS: Six hundred eighty-six cases with a mean age of 72.1 years were enrolled in a 2-phase U.S. Food and Drug Administration (FDA) clinical study of the Collamer IOL implanted during phacoemulsification for cataract removal. The 12 month follow-up comprised data from 502 cases. RESULTS: Twelve months postoperatively, 96.2% of all cases and 95.6% without preexisting pathology achieved 20/40 or better best corrected visual acuity. Both results were better than FDA Grid values. No persistent sight-threatening complications, IOL dislocations, or IOL removals were reported. CONCLUSIONS: Results show that the Collamer IOL is safe and effective for use in small incision cataract surgery.

Aged↗
PubMed2003

Lessons learned from aortic aneurysm stent graft failure; observations from several perspectives.

Since the first US report of endovascular repair of abdominal aortic aneurysm in 1995, many lessons have been learned from the growing reports of successes and failures. This article combines experience with 6 endograft types plus examples from the literature to summarize lessons learned from a variety of stent graft failures classified according to (1) failure of patient selection, (2) procedural failure, and (3) failure of the endovascular device.

Angioplasty↗
PubMed2003

The Zenith AAA endovascular graft for abdominal aortic aneurysms: clinical update.

PURPOSE: The aim of this study was to provide an update regarding the US clinical trial assessing the performance of the Zenith AAA Endovascular Graft in the treatment of abdominal aortic aneurysms. MATERIALS AND METHODS: A prospective, nonrandomized, concurrent control-based study design was used to contrast conventional repair of infrarenal aneurysms with endovascular repair in patients that would otherwise be candidates for open surgical procedures. Additional study arms allow high-physiologic-risk patients and roll-in patients to be treated using the same endovascular device in a registry format. Patients were evaluated clinically and radiographically computed tomography (CT) and abdominal radiographs) before any intervention, at hospital discharge, 30 days, 6 months, 12 months, and yearly thereafter. Data were analyzed with the intent of assessing acute and chronic morbidity and mortality, radiographic parameters indicative of successful aneurysm repair, and device integrity. RESULTS: A total of 352 patients were treated with the Zenith graft (one patient did not receive an implant in the standard-risk group), and 80 patients underwent conventional surgical repair. Two hundred patients were enrolled in the standard-risk group, 100 in the high-risk group, and 52 underwent endovascular repair as roll-in patients. All cause mortality, aneurysm-related deaths, and ruptures were statistically identical between the groups. Procedural morbidity was significantly lower for patients treated with endovascular grafts with respect to cardiac, pulmonary, renal, and vascular complications. Secondary interventions were more commonly required in the endovascular group. The endoleak rate was 4.9% at 12 months in the standard-risk endovascular group. There was one rupture in the high-risk subset of patients and 3 elective conversions. A total of 1.6% of the endovascular patients were noted to have a barb separation without evidence of significant migration or clinical events. No other device integrity issues were observed. CONCLUSIONS: The safety of the Zenith endovascular graft was superior to conventional management with respect to morbidity and clinical utility. The short-term device efficacy was satisfactory; however, longer-term follow-up will be necessary to establish the duration of this observation.

Aged↗
PubMed2003

The Gore Excluder US multi-center trial: analysis of adverse events at 2 years.

Although open surgical repair of abdominal aortic aneurysms remains the standard of care, endovascular repair is becoming an attractive alternative as more long-term outcome data become available to show its safety and efficacy. The authors review data on the 2-year outcome of the pivotal US multicenter, prospective Gore Excluder Trial. Patients treated with the Excluder endograft (W.L. Gore, Flaggstaff, AZ) had less blood loss (310 +/- 19 v 1,590 +/- 124 mL; P <.0001), required fewer homologous transfusions (6% v 32%; P <.0001), and had faster inpatient recovery (2.0 +/- 0.1 v 9.8 +/- 1.4 days; P <.0001) compared with those treated with open repair. Early major adverse events were reduced significantly in the patients treated with the endograft (14% v 57% in control; P <.0001), and this persisted at 2 years. There was no difference in overall survival rate (P =.13). There were no deployment failures, early conversions, or aneurysm ruptures. At the 2-year time-point, trunk migration occurred in 1%, limb migration in 1%, limb narrowing in 1%, endoleak in 20%, and aneurysm growth in 14%. There was a 7% annual reintervention rate in the endograft group in the first 2 years. The Excluder endograft is a safe and effective treatment compared with open surgical repair for infrarenal abdominal aortic aneurysms with appropriate anatomy.

Aged↗
PubMed2003

Current contact lens care systems.

Contact lens care has been revolutionized and simplified with the development of multipurpose solutions, less sensitizing preservatives and disinfectants, better protein removers, and reaction-free, one-bottle care systems for patients who have had adverse responses to existing care products. As the complexity of lens care has decreased, compliance has increased. Nevertheless, good compliance is dependent on technician training and a thorough understanding of the chemistry and mechanism of action of each care system. Care products are constantly evolving, and the practitioner should become familiar with each new solution as it is introduced to ensure that patients are also kept up-to-date.

Contact Lens Solutions↗
PubMed2002

A new video laryngoscope-an aid to intubation and teaching.

In recent decades, video techniques have been employed in the majority of endoscopic procedures because of several distinct advantages provided. These include the following: The displayed anatomy is magnified. Recognition of the anatomical structures and anomalies is easier, and manipulation of airway devices is facilitated. When assistance is required, the operator and assistant can coordinate their movements because each sees exactly the same image on the video monitor. As a result, video techniques have become the method of choice in teaching. The Video Macintosh Intubating Laryngoscope System (VMS) was designed employing a standard Macintosh blade and laryngoscope handle. A camera was incorporated into the handle with a short image and light bundle. The magnified anatomy is displayed on an 8-inch monitor, which is attached to a swivel arm on a small cart. Observation and manipulation can be performed in one axis.A total of 235 patients were studied and were divided into two groups: Group A (n = 217), in whom intubation was thought unlikely to be difficult, and Group B (n = 18), in whom difficulty with intubation was anticipated. External laryngeal manipulation (ELM) was required in 22 of the 217 Group A patients (10%). All intubations but one in this group were successful. In the second group (B) of 18 patients who had anatomical conditions that suggested that direct laryngoscopy might be challenging, all 18 cases required ELM but all were successfully intubated using the VMS. The improved coordination afforded by an image on a video monitor seen by both the assistant providing laryngeal manipulation and the anesthesiologist handling the laryngoscope results in a significant advantage over the conventional laryngoscope technique. As a consequence, the learning curve is short. In our view, video laryngoscopy will become the method of choice in teaching.

Anesthesiology↗
PubMed1999

CE marking--what does it really mean?

Compliance with the Medical Devices Directive (93/42/EEC) became compulsory for all medical devices placed on the European market in June 1998. Under the directive, manufacturers are required to fulfil a number of requirements leading to the placing of the CE mark on their devices. However, many questions still remain. Not all manufacturers are aware of their responsibilities and not all purchasers are aware of the true meaning of the CE mark. It is vital to understand the purpose of the regulations, the definition of 'medical device', the importance of complying with the manufacturer's intended purpose and instructions, the role of quality systems and clinical investigations in the compliance process, and the decisions which may be made by the manufacturers. It is also important to realise that whilst the directive, if correctly applied and enforced, brings benefits to the medical industry and patients, it is not a substitute for professional judgement in the purchasing process.

Consumer Product Safety↗