Nicola Osypka's German company has been selling medical devices used in surgery on newborn babies in Europe for decades, but new European Union rules have forced her to make tough decisions as companies withdraw essential devices
Under the regulations designed to prevent another health scandal, such as the one in 2010 involving ruptured breast implants made by Poly Implant Prothese, companies must apply for new certificates for their medical equipment.
, that are withdrawing devices from the EU market, or have stopped making them due to the cost it takes to comply with the rules. The eight manufacturers all said the requirements were stretching the time it takes to get a certificate for a product line to as much as two-and-a-half years, compared with a few months under the old system.
The doctors, in Austria, Belgium and Germany, said in some cases they were unable to provide their standard quality of care because devices for routine procedures were no longer available. Nicola Osypka, a molecular biologist, said she sat down with staff to run the numbers on their niche products, such as a miniscule catheter used to keep newborns with non-functioning heart valves alive until surgery can be performed.
The company's new stent for babies was developed over eight years and doctors successfully used it on 19 babies during the trial in Germany, according to the results seen by Reuters.
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