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At least 685 records · Page 38Linked to original sources
PubMedDate not supplied

Wavefront-guided treatment for previous laser in situ keratomileusis and photorefractive keratectomy: case reports.

PURPOSE: To describe the off-label use of the Alcon LADARVision System for CustomCornea (LADARWave and LADARVision4000) in two patients, one for retreatment after laser in situ keratomileusis (LASIK) and one for retreatment after photorefractive keratectomy (PRK). METHODS AND RESULTS: Both patients were unhappy with the quality of their vision after initial refractive surgery. The first patient initially had LASIK to correct -4.75 D of myopia in each eye, and then had retreatment with CustomCornea. Before retreatment, manifest refraction was OD 0.50 -0.50 x 180 degrees (20/25 uncorrected) and OS -0.50 -0.75 x 180 degrees (20/40 uncorrected). Two months after retreatment with CustomCornea, his uncorrected visual acuity OD was 20/15, and 1 month after retreatment in his left eye, uncorrected visual acuity was 20/15. The second patient had PRK OD, with a postoperative uncorrected visual acuity of 20/25 and cycloplegic refraction of +1.00 -0.75 x 84 degrees. After CustomCornea retreatment, his 3.5-month postoperative uncorrected visual acuity was 20/15 and manifest refraction was +0.50 -0.50 x 180 degrees. CONCLUSION: The Alcon LADARVision System for CustomCornea was used effectively to retreat both a myopic LASIK and myopic PRK patient, primarily for subjective quality of night vision complaints.

Adult↗
PubMed1996

Silicone breast implants: implications for society and surgeons.

In the last two years, scientific studies have confirmed that there is no significant increase in risk of subsequent breast cancer, connective-tissue disease or symptoms in women with silicone gel-filled breast implants. Despite this evidence, a moratorium (in place since 1992) on the use of these prostheses in the United States has been maintained by the pressure of overwhelming litigation. At the same time, Australian authorities also announced a moratorium, restricting the availability of silicone breast implants. Huge damages awarded by United States courts forced Dow Corning, manufacturer of a large percentage of breast prostheses, to file for Chapter 11 bankruptcy in May 1995. This effectively terminated the major source of implantable silicone for medical use. The withdrawal of implantable silicone and other implantable prosthetic material will be a significant loss for surgeons and society. This paper will highlight the consequences if reasoned scientific data are not relied on by Australian courts to assess claims for damages relating to medical devices.

Australia↗
PubMed2001

Automated external defibrillators: technical considerations and clinical promise.

Early defibrillation is the most important determinant of survival for victims of cardiac arrest due to ventricular fibrillation. The automated external defibrillator (AED) was developed as the result of the American Heart Association's Public Access Defibrillation initiative. The goal of this initiative is to place AEDs in strategic locations so that laypersons with minimal training could promptly defibrillate victims of cardiac arrest. Because of changes in design and the use of alternative waveforms for defibrillation, the modern AED is compact and portable, simple to use, and highly efficacious; in addition, it requires little maintenance. Automated external defibrillators have been used successfully by traditional and nontraditional responders as well as laypersons. In special environments, such as casinos and commercial aircraft, AEDs have performed particularly well. State and federal legislation has eased concerns about AED use by extending legal protection to AED users under Good Samaritan laws. Since the experience continues to be positive, AEDs are being used in increasingly diverse community locations, and public awareness is growing. The American Heart Association's initiative is progressing rapidly.

Aircraft↗
PubMed1994

Delegations of authority and organization; Center for Devices and Radiological Health--FDA. Final rule.

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority relating to general redelegations of authority from the Associate Commissioner of Regulatory Affairs to certain FDA officials in the Center for Devices and Radiological Health (CDRH). The redelegation provides these officials with authority to grant or deny certain citizen petitions for exemption or variance from medical device tracking requirements. This action is being taken to facilitate expeditious handling of citizen petitions. FDA is also issuing a conforming amendment to the medical device tracking regulations to make the regulations consistent.

Device Approval↗
PubMed1994

Letter to manufacturers of blood establishment computer software products--FDA. Notice.

The Food and Drug Administration (FDA) is publishing a letter sent to known manufacturers of blood establishment computer software products. In the letter, FDA advised these manufacturers that it considers these computer software products to be devices under the Federal Food, Drug, and Cosmetic Act (the act) because these products aid in the prevention of disease by identifying unsuitable donors and preventing the release of unsuitable blood and blood components for transfusion or for further manufacturing use. The letter, accompanied by a registration package and device listing was intended to notify manufacturers of the requirements of the act, to facilitate registration of these manufacturers as medical device manufacturers, and to further ensure the safety of the blood supply.

Blood Banks↗
PubMed1994

Delivery and funding are provincial matters in Canada.

The following article is one of a series that deal with the provision of health care services around the world. Other countries in the series include Germany, Italy, Japan, Mexico, the Netherlands, and the United States. Countries scheduled for coverage in the series include Austria, France, Singapore, Spain, and the United Kingdom. The countries are described using a grid of characteristics so that comparisons may be made more easily. All of the analyses, along with further comparative data, will be gathered into a freestanding book to be published later in the year. Dr. Mendoza serves as editor for the project.

Canada↗
PubMed1995

Hospitals try to devise solutions in device debate.

A federal probe into hospitals' billing for investigational medical devices is raising more questions in the debate among providers, payers and equipment manufacturers over research and testing of new technologies and who should pick up the tab.

Clinical Trials as Topic↗