Scientists Find Safer Ways To Test Medical Procedures

The Wall Street Journal | SHIRLEY S. WANG

Scientists are developing ever more sophisticated versions of "virtual patients" with the aim of testing medical devices and procedures that can't readily be assessed in real people.

Medical innovations typically undergo extensive trials before they are approved for use in people. But sometimes such analysis isn't practical because of the risks to patients. Medical testing, for example, is rarely done in children and pregnant women due to worries about what a procedure could do to a growing body.

Virtual patients can help estimate how much radiation a fetus gets during a mother's CT scan.

Virtual patients are realistic-looking computerized models. They use medical data and computer software and graphics to mimic real people, with skin, bones, fat and organs of realistic size, shape and composition. Scientists are currently testing virtual patients to answer such questions as: How much radiation are various organs in the body exposed to as a result of a CT scan? How risky is it for a pregnant woman to get a scan? Should a heart device like a defibrillator be implanted in a child differently than in an adult?

Η Ευρωπαϊκή επιτροπή εξέδωσε στις 20 Δεκεμβρίου νέα Οδηγία για τις “In Vitro” διαγνωστικές ιατρικές συσκευές.

Commission Directive 2011/100/EU of 20 December 2011 amending Directive 98/79/EC of the European Parliament and of the Council on in-vitro diagnostic medical devices

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in- vitro diagnostic medical devices (1 ), and in particular Article 14 thereof,

Whereas:

(1) In accordance with Article 14(1)(a) of Directive 98/79/EC, the United Kingdom has requested that the Commission take the necessary measures to add ‘Variant Creutzfeldt-Jakob disease’ (vCJD) assays to List A of Annex II to that Directive. 

(2) In order to ensure the highest level of health protection and ensure that the conformity of vCJD assays with the essential requirements set out in Annex I to Directive 98/79/EC is verified by notified bodies, vCJD assays for blood screening, diagnosis and confirmation should be added to List A of Annex II to Directive 98/79/EC. 

(3) The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Article 6(2) of Council Directive 90/385/EEC ( 2 ) and referred to in Article 7(1) of Directive 98/79/EC,

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http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:341:0063:0064:EN:PDF

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The ultimate guide for Pharma Marketing Champions

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As Doctors Use More Devices, Potential for Distraction Grows

New York Times | Matt Richtel 

Hospitals and doctors’ offices, hoping to curb medical error, have invested heavily to put computers, smartphones and other devices into the hands of medical staff for instant access to patient data, drug information and case studies. 

But like many cures, this solution has come with an unintended side effect: doctors and nurses can be focused on the screen and not the patient, even during moments of critical care. And they are not always doing work; examples include a neurosurgeon making personal calls during an operation, a nurse checking airfares during surgery and a poll showing that half of technicians running bypass machines had admitted texting during a procedure. 

This phenomenon has set off an intensifying discussion at hospitals and medical schools about a problem perhaps best described as “distracted doctoring.” In response, some hospitals have begun limiting the use of devices in critical settings, while schools have started reminding medical students to focus on patients instead of gadgets, even as the students are being given more devices.