Guide Medical Diagnostics Laboratories in India: A Strategic Reference, 2007

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Examples include laboratory reagents, rapid diagnostic tests, calibrators and control kits. Therefore, the availability of MDs and IVDs of assured quality is a critical prerequisite to effective and safe healthcare. However, large gaps between the North and South exist, not only in terms of access to MDs and IVDs Zarocostas but also in terms of quality assurance.


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For operational purposes, and pending harmonized definitions, counterfeit IVDs could be — in line with counterfeit drugs — defined as deliberately mislabelled products e. Examples include counterfeits, e. However, they often focused on few selected technical items, so data are on a limited set of problems i. In Vietnam, a case of tampering with beta lactate test strips from Roche was reported: the expiry date of the product had been fraudulently altered on the strips themselves, the package inserts and the boxes they appeared to expire in , when in fact they had expired in This discrepancy can be explained by several factors.

This initiative represents an important step towards harmonization worldwide. It was emulated, in , by the Asian Harmonization Working Party. To our knowledge, no common regulatory initiatives are promoted as of yet amongst African countries. The WHO supports this strategy WHO ; however, the regulatory authority of the recipient country should check these labels with the body, which granted the certificate, as is done by the Egyptian health authorities Emergo b.

This applies, for instance, to HIV diagnostic tests. By contrast, for IVDs not listed in the Annex II — such as malaria rapid diagnostic tests and IVDs for other parasitic diseases — the CE mark is obtained by filling in a technical file and a declaration of conformity by the manufacturer European Commission a , rendering the acquisition of the CE marking label to a purely administrative process.

Recently, the U. FDA assessments on the k premarket process products not in the highest class of risk had been under review to facilitate innovation initiatives and face unmet public health needs Roehr This classification considers the diagnostic information of an IVD as well as the impact of its results whether true or false to the individual and the public health GHTF a. From the GHFT perspective, most IVDs for tropical infectious diseases such as malaria rapid diagnostic tests fit into Class C, which corresponds to a moderate public health risk or a high individual risk, whereas HIV screening tests fit into Class D, which corresponds to high individual and high public health risk.

If the requirements, particularly those for Class C IVDs, are strict enough, this revision could represent a significant step towards supporting countries with weak regulatory supervision. We thank our colleagues for informal communication on this topic and Gillet Philippe for helpful discussions and advice.

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Acknowledgements go to Dr. Hooghe Robert, Prof. Volume 16 , Issue The full text of this article hosted at iucr. If you do not receive an email within 10 minutes, your email address may not be registered, and you may need to create a new Wiley Online Library account.

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Share Give access Share full text access. Share full text access. Please review our Terms and Conditions of Use and check box below to share full-text version of article. Figure 1 Open in figure viewer PowerPoint. Reports are listed in the chronological order of their appearance in the literature. Acknowledgements We thank our colleagues for informal communication on this topic and Gillet Philippe for helpful discussions and advice. American Journal of Roentgenology , Google Scholar. PubMed Google Scholar.

Three years previously, in , Werner von Siemens put one of his inventions to use for medical purposes for the first time, using electricity to treat his brother Friedrich for tooth pain.

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After teaming up with Halske, the new company's products included electromedical equipment. In Aschaffenburg , Germany , X-ray pioneer Friedrich Dessauer founded his own company, which later came to prominence under the name Veifa-Werke. The company soon came to be viewed as the world's largest specialized electromedical company.

Supported by Siemens in Erlangen , Inge Edler, a Swedish physician, and physicist Carl Hellmuth Hertz were intrigued by the idea of using ultrasound technology to achieve more precise heart diagnoses.

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In , they became the first to use the ultrasound technique for echocardiography. Today, this powerful ultrasound process is a standard component of all cardiovascular examinations. Siemens engineer Ralph Soldner developed the world's first "real-time" ultrasound unit, the Vidoson, in the s. The company released its first computed tomography scanner, the Siretom, in , a year after it exhibited its first tomographic image of a human head at the annual meeting of the Radiological Society of North America in Chicago.

The skull is scanned from various directions by an X-ray tube and a detector unit, and an image of absorption distribution in the brain is generated in the computer. With the aid of powerful magnetic fields, MRI scanners produce high-quality cross-sectional images without exposing patients to radiation.

The sectional images displayed tissues and organs more clearly than ever before. Siemens introduced the first track-based laboratory automation system—the ADVIA LabCell Automation Solution in , allowing for increased efficiency and reduced costs. The company's imaging devices use syngo, an image processing software developed by the company in The software provides a single user interface for a large number of imaging systems, integrating patient-specific physiological and imaging data into clinical workflows.

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In doing so, the combination system gives a more detailed image of anatomy and biological function. The change reflected part of the Siemens AG Vision strategy announced nearly two years previously that its healthcare business would be separately managed as a company within the company with a new organizational setup. In November the company announced its intention to become publicly-listed on the Frankfurt Stock Exchange in March Siemens Healthineers has supported charitable giving around the world. The company has also contributed to disaster relief efforts.

Siemens Healthineers provided the relief efforts with a magnetic resonance imaging machine in addition to the funds donated by Siemens AG. Established in , DPC produced immunodiagnostics and supplies for fertility diagnosis and in-vitro allergy testing.

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Y, from Bayer AG. The company provided a range of services for in-vitro diagnosis. In November , Siemens acquired Dade Behring, a producer of clinical laboratory equipment and integrated solutions for routine chemistry testing, immunodiagnostics including infectious disease testing , hemostasis testing, and microbiology.

The business was sold to Cerner in In November , Siemens Healthineers acquired Conworx Technology GmbH, a Berlin-based developer of point-of-care device interfaces and data management solutions. On 4 May , current Healthcare Sector CEO Bernd Montag introduced to the public the new brand name "Healthineers," along with a five-minute dance routine celebration outside the Healthineers headquarters in Erlangen.


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This caused immense PR backlash and ridicule for the company and its employees. The Financial Times called it a "Writhing spandex clad horror.

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