Developments In European Standards For Medical Gloves

This is a general overview of the legislation that governs the sale of medical gloves into the European Union including an explanation of the role that the manufacturer and the supplier are expected to play in certifying gloves to the Medical Devices Directive and a guide to the key Standards is provided. Finally a guide is given to future developments in the EN455 standards.

The regulations that affect the export of rubber gloves for medical use and the Standards that have been created to support them are constantly evolving. The aim of this evolution is the provision of ever better glove performance and levels of protection for the end user and the patients that they care for. Unfortunately this evolution can lead to confusion for the suppliers and manufacturers who are producing the product.

This paper aims to clarify the current situation with respect to which Standards and regulations apply to gloves as well as provide a guide to some of the changes to the Standards that are expected to occur during the next decade. Click here for details.

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Study of sublingual immunotherapy in patients with latex-induced urticaria (British Journal of Dermatology)

Department of Clinical Medicine, Immunology and Infectious Deseases, University of Bari, Bari, Italy.

BACKGROUND: Natural rubber latex (NRL) allergy is a worldwide problem. Although prevention is sufficient to reduce sensitization, prolonged avoidance is needed to prevent resensitization or adverse reactions on re-exposure.

OBJECTIVES: This double-blind, placebo-controlled study was conducted to determine the efficacy of sublingual immunotherapy (SLIT) with latex. METHODS: Forty patients with NRL allergy were enrolled. At diagnosis, 30 presented urticaria and 10 asthma. Patients were evaluated on their clinical history and an allergological assessment: skin prick test with latex extract, serum-specific IgE and provocation tests. Patients were subdivided by complaint (asthma or urticaria), and randomized to receive SLIT with latex extract (ALK-Abelló, Lainate, Milan, Italy) or placebo.

RESULTS: The evaluable population consisted of 35 patients, 18 treated with SLIT and 17 with placebo. The results show that 12 months of SLIT improved the symptoms score and reduced the medication score in all subjects. The subjective evaluation was corroborated by improved bronchial and glove provocation test results.

The latex-specific IgE levels increased slightly in the SLIT group, and skin sensitization was reduced at the end of the trial in all the patients treated with SLIT. The immunotherapy was not complicated by any severe adverse reactions.

CONCLUSIONS: This is the first double-blind, placebo-controlled evaluation of the efficacy of SLIT with latex extract conducted in adult patients allergic to NRL. SLIT with latex can be proposed for subjects with latex allergy, especially those for whom complete avoidance of latex exposure may be very difficult or even impossible. More studies are needed to evaluate the efficacy of SLIT in the treatment of subjects with latex allergy who are sensitized to inhalant allergens.

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REMINDER - FDA Final Rule on AQLs

Food and Drug Administration

21 CFR Part 800

[Docket No. 2003N-0056 (formerly 03N-0056)]

Medical Devices; Patient Examination and Surgeons' Gloves; Test Procedures and Acceptance Criteria

AGENCY: Food and Drug Administration, HHS. ACTION: Final rule.

SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule to improve the barrier quality of medical gloves marketed in the United States. The rule will accomplish this by reducing the current acceptable quality levels (AQLs) for leaks and visual defects observed during FDA testing of medical gloves. By reducing the AQLs for medical gloves, FDA will also harmonize its AQLs with consensus standards developed by the International Organization for Standardization (ISO) and ASTM International (ASTM).

DATES: This rule is effective December 19, 2008.

FOR FURTHER INFORMATION CONTACT: Casper E. Uldriks, Office of Compliance, Center for Devices and Radiological Health (HFZ-300), Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 240- 276-0100.

You are at the site for answers and solutions to all your problems in natural rubber latex processing and manufacturing of industrial, household and medical gloves, condoms, catheters, baby teats and baby pacifiers, toy balloons, latex foam products, latex threads etc.