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The practice of reusing medical devices labeled for only one use began in hospitals in the late 1970s. [8] After a thorough review by the U.S. FDA in 1999 and 2000, [8] the agency released a guidance document for reprocessed SUDs that began regulating the sale of these reprocessed devices on the market, [9] under the condition that third-party reprocessors would be treated as the manufacturer ...
The Fair Packaging and Labeling Act is a U.S. law that applies to labels on many consumer products. It requires the label to state: The identity of the product; The name and place of business of the manufacturer, packer, or distributor; and; The net quantity of contents. The contents statement must include both metric and U.S. customary units.
Single-use medical devices include any medical equipment, instrument or apparatus having the ability to only be used once in a hospital or clinic and then disposed. The Food and Drug Administration defines this as any device entitled by its manufacturer that it is intended use is for one single patient and one procedure only. [ 1 ]
In the US, the Fair Packaging and Labeling Act provides requirements for many types of products. Also, NIST has Handbook 133, Checking the Net Contents of Packaged Goods. [ 25 ] This is a procedural guide for compliance testing of net contents and is referenced by several other regulatory agencies.
A drug label retrieved from a random clinic in Hong Kong. Over-prominence of the logo of clinics may be susceptible to the poor interpretation of drugs by patients. An effective drug label should demonstrate efficacy and safety. Imperfect drug label information or design may lead to misinterpretation and hence medication errors.
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Precautionary statements form part of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). [1] They are intended to form a set of standardized phrases giving advice about the correct handling of chemical substances and mixtures, which can be translated into different languages.
It is updated every five years and its latest 11th [2] version of the system groups products into 45 classes (classes 1-34 include goods and classes 35-45 embrace services), and allows users seeking to trademark a good or service to choose from these classes as appropriate. Since the system is recognized in numerous countries, this makes ...
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