re: Ann: Announces new Autostart Burette Prod...
To those worried about the "made in china" issue:
Analytica is covering all bases by making sure that the quality of their products adhere to the International Standards Organisation (ISO) standard. According to their last announcement, an independent third party is doing the testing and validation studies - including Sterilisation Validation, accelerated aging and product shelf life validation, and ISO 10993 biocompatibility testing.
Biocompatibility is a measurement of how compatible a device is with a biological system. The purpose of performing biocompatibility testing is to determine the fitness of a device for human use, and to see whether use of the device can have any potentially harmful physiological effects.
ISO 10993 includes these sub categories:
ISO 10993-1: Evaluation and testing in the risk management process ISO 10993-2: Animal welfare requirements ISO 10993-3: Tests for genotoxicity, carcinogenicity and reproductive toxicity ISO 10993-4: Selection of tests for interactions with blood ISO 10993-5:Tests for in vitro cytotoxicity ISO 10993-6: Tests for local effects after implantation ISO 10993-7: Ethylene oxide sterilization residuals ISO 10993-8: Selection of reference materials ISO 10993-9: Framework for identification and quantification of potential degradation products ISO 10993-10:Tests for irritation and delayed-type hypersensitivity ISO 10993-11:Tests for systemic toxicity ISO 10993-12: Sample preparation and reference materials ISO 10993-13:Identification and quantification of degradation products from polymeric medical devices ISO 10993-14:Identification and quantification of degradation products from ceramics ISO 10993-15:Identification and quantification of degradation products from metals and alloys ISO 10993-16:Toxicokinetic study design for degradation products and leachables ISO 10993-17:Establishment of allowable limits for leachable substances ISO 10993-18:Chemical characterization of materials ISO/TS 10993-19:Physico-chemical, morphological and topographical characterization of materials ISO/TS 10993-20:Principles and methods for immunotoxicology testing of medical devices.
Analytica's product has to pass the relevant sections before it can be used in the US trials.
The Autostart burette is designed to meet International burette standards ISO 8536-5 and infusion set standard ISO 8536-4:2004, ISO 594-2:1998, ISO 10993-1:2003, and ISO 15223:200 (where applicable).
The manufacturer they were using in 2008 was an ISO 13485:2003 certified facility. Although they appear to have changed manufacturing facilities, they stated in their recent announcement that the recent production run "also provided an opportunity for our manufacturing partner to be audited as a burette manufacturer" I.e - the new manufacturer is being currently audited to make sure that it satisfies ISO standards for burette manufacturing and can be certified to those standards.
The Autostart Burette has CE marking.
Hospitals are probably already using "Made in China" Burettes now anyway so what is the difference? The purchasing officers in hospitals won't really care where it is made. They will be thinking of the bottom line.
The difference is the superiority of the product because of it's design. I can't see where it is made being an issue. If it is an issue for you - please feel free not to invest but consider the above points.
ALT Price at posting:
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