Methods and apparatuses for assuring quality and safety of drug administration and medical products and kits
First Claim
1. A medical product marked with a quality assurance module, wherein said quality assurance module stores information relating to the product, said information comprising an identifier unique to the medical product and/or to the origin of the product.
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Abstract
The present invention provides apparatuses and methods for marking components, supplies and kits of drug administration devices and other medical systems with quality assurance information. The invention also provides apparatuses and methods for tracking time of use of such components, supplies and kits and various apparatuses and methods for preventing use or reuse of tainted, recalled or unrecognized components, supplies and kits. Quality assurance markers (QAMs) are described which store information regarding the identity and manufacturer of disposable components, supplies and kits. The invention utilizes several QAM modalities, such as, among others, 1-D and 2-D bar codes, 1-D and 2-D symbologies, holograms, written text, radio frequency identification devices (RFIDs), integrated chip smart cards, and EEPROMs.
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Citations
41 Claims
- 1. A medical product marked with a quality assurance module, wherein said quality assurance module stores information relating to the product, said information comprising an identifier unique to the medical product and/or to the origin of the product.
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22. An integrated drug delivery system, said system comprising:
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a patient health monitor device adapted so as to be coupled to a patient and generate a signal reflecting at least one physiological condition of the patient;
a drug delivery controller supplying one or more drugs to the patient;
at least one medical product removably coupled to the system, said product having a quality assurance module for storing information regarding the product, wherein the quality assurance module comprises an identifier unique to the medical product and/or to the origin of the product;
a reader device for reading information stored on the quality assurance module of said medical product;
a memory device storing a safety data set reflecting safe and undesirable parameters of at least one monitored patient physiological condition and reflecting safe and undesirable parameters of the medical product; and
an electronic controller interconnected between the patient health monitor, the drug delivery controller, the reader device, and the memory device storing the safety data set;
wherein said electronic controller receives said signals and in response manages the application of the drugs in accord with the safety data set. - View Dependent Claims (23, 24, 25, 26, 27, 28)
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29. A drug delivery apparatus, said apparatus comprising:
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a drug delivery controller supplying one or more drugs to the patient; and
at least one medical product removably coupled to the apparatus, said product having a quality assurance module for storing information regarding the product, wherein the quality assurance module comprises an identifier unique to the medical product and/or to the origin of the product.
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30. A method of assuring quality, safety, and/or certified manufacture of a medical product to be used with a medical system, said method comprising the steps of tagging the medical product with a quality assurance module, wherein said quality assurance module comprises information related to the medical product including an identifier unique to the medical product and/or to the origin of the product;
- sensing the information on the quality assurance module;
comparing the information to parameters, wherein the parameters are pre-defined as signifying quality, safety, and/or certified manufacture;
rejecting the use of the medical product with the medical system if said comparison suggests that the product is not of quality, safety, and/or certified manufacture. - View Dependent Claims (31, 32, 33, 34, 35, 36, 37, 38, 39, 40)
- sensing the information on the quality assurance module;
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41. A cassette for use with an intravenous infusion apparatus, wherein said cassette is removably attachable to the intravenous infusion apparatus, and wherein said cassette comprises a mechanical use indicator which undergoes alteration upon being attached or upon being removed from the infusion apparatus, and wherein the alteration of the use indicator is sensed by a use detector provided with the infusion apparatus.
Specification