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Vacuum assisted closure (VAC) therapy is designed to promote the formation of granulation tissue for faster healing in the wound beds of patients with acute and chronic wounds. Four controlled trials and one interim analysis provide poor quality data and weak evidence that VAC therapy may be superior to conventional methods used in healing wounds. Complications with VAC therapy are uncommon. Studies are needed to evaluate the effectiveness of VAC therapy when the types of dressings are the same for patients in the groups being compared and VAC therapy is the only differing intervention.
This round-up of packaging myths provides a reality check on the real world of packaging medical products. Table I shows medical device FDA-assisted recalls due to packaging failures.
An effective evaluation of the functioning of the Medical Device (MD) Directive is of the utmost importance and has global significance. This article discusses the official review of the MD Directive, its conclusions, and some of the more important activities resulting from the review.
A look at some of the developments of 2002 from the regulator's perspective.
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Compliance officers and financial managers should forge an alliance to ensure their organization's ethics and integrity. Many financial and compliance issues stem from clinical research. Billing for experimental devices must follow specific rules, especially when payment is from Medicare. The charge description master should receive detailed attention to improve efficiency and net revenues. Violations of protected health information can have serious financial implications.
Have you ever wondered what really goes on at the United States Food and Drug Administration (FDA)? At each meeting of the Society of Otorhinolaryngology and Head-Neck Nurses (SOHN) and the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) the FDA is repeatedly mentioned, and not always favorably! This article discusses the process of bringing new medical devices to market and explains how ORL (or ENT) nurses can contribute to the protection of the public health by providing medical device adverse event information to FDA.
Under the In Vitro Diagnostic (IVD) Directive, a manufacturer of IVD medical devices located outside the European Economic Area must designate an Authorized Representative before placing those products on the European market. This article discusses the responsibilities of Authorized Representatives under the IVD Directive and some of the important differences of the role as it is defined in the Medical Device Directive.
The Food and Drug Administration (FDA) is issuing a final rule to amend the classification regulations for eight surgical suture devices previously reclassified into class II to specify a special control for those devices. The special control is an FDA guidance document entitled "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA" that identifies performance, testing, and labeling recommendations for the devices. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control. FDA is taking these actions on its own initiative because it believes they are necessary to provide reasonable assurance of the safety and effectiveness of surgical suture devices. These actions are being taken under the Federal Food, Drug, and Cosmetic Act (the act).
Until recently, surgical repair was the standard treatment for an ostium secundum atrial septal defect (ASD), a common congenital heart defect. Closing ASDs using a device inserted via a catheter now offers another option for some patients. Limited comparative data indicate that newer approaches to transcatheter repair have a higher failure rate than that for surgery, but short-term complication rates are lower. Evidence from long-term follow-up of patients with device closure of ASDs is not yet available. Equipment and procedure costs may be higher for transcatheter closure than for surgery, but overall costs may be reduced through avoiding intensive care unit costs and through shorter hospital stays.
Modern production processes are designed to minimise chances of error and poor judgement, yet sometimes events occur that initially seem trivial, but ultimately prove fatal. In these circumstances, associations between cause and effect can become distorted and are often difficult to overcome.
The changes introduced by the Medical Device User Fee and Modernisation Act should ensure a timely and effective review process. The impact of some of the reforms is discussed here.
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Compared to chest radiography, multislice/helical computed tomography (CT) is able to detect lung cancers of smaller size and at an earlier stage, when better outcomes may be possible. However, the rate of detecting benign lung nodules is high using these technologies. False positives can result in undue anxiety and/or additional tests that may be invasive and expensive. Currently evidence does not exist to suggest that detecting early stage lung cancer reduces mortality. Randomized controlled trials are underway to investigate this issue. Presently, even for smokers, screening for lung cancer with multi-slice/helical CT would be premature.
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