Wiehl, 22 November 2019 – Compamed is over and Dr. Andreas Ostrowicki, Managing Director of BGS, sums up the trade fair positively. On one hand, the company was able to welcome more visitors to the BGS stand than in previous years. On the other hand, there was increasing interest in alternative sterilization methods and advice regarding second-source solutions following the ongoing critical coverage on ETO sterilization and facility shutdowns in the US market. Under the motto “Energy that changes everything”, BGS actively contributed to creating awareness for themes like validation and process integration of radiation sterilization, as well as giving advice on the related regulatory requirements.
“As leading provider of sterilization services and solutions in the area of industrial application of beta and gamma rays, Compamed is a fixed date each year for BGS,” comments Dr. Andreas Ostrowicki. “The trade fair has high priority for us as a platform to exchange views and ideas with industry representatives and business partners. Despite sustained growth in the industry, the mood among medical technology companies was slightly subdued. One of the main reasons for this is the transition period of the EU Medical Device Regulation which will soon be expiring, combined with the ensuing uncertainty of marketing medical devices.” Many manufacturers fear they will not be able to place their devices on the market in a timely manner due to longer evaluation procedures. Central themes of concern in the industry were also the question of ensuring the necessary sterilization capacities commensurate with market growth, as well as establishing second sources for sterilization.
Sterilization of medical devices: Attention shifts to reducing failure risks
“The talks at the trade fair showed that the demand for double qualifications and back-up solutions for manufacturers of medical devices is becoming increasing relevant,” explained Ostrowicki. “In the context of risk assessment, every manufacturer should ask himself what would happen if there was a shutdown in the plant commissioned with the sterilization services. The most recent cases in the US show that longer shutdowns not only result in severe financial losses, but may in certain circumstances also lead to considerable supply gaps on the market; creating a second source is therefore absolutely advisable. Here, it was necessary to examine in each case whether the device in question at the existing service provider could be qualified for a second facility, whether contracts should be concluded with an additional provider, or whether a qualification for another method of sterilization was the best prevention to forestall failure risks. BGS has been following the principle of ‘redundancy’ for years now. This means that each of the three locations of the company is able to take over the processes of the other locations, thus increasing the reliability in the production.
You will find further information about radiation sterilization of medical devices and consumables for laboratories and biotechnology, amongst other things, here.