How safe are the medical devices?


Medical devices used in healthcare organization can also pose a risk. Many of them are sometimes either not safe for diagnosis or prone to hacking. Poor monitoring of the safety of medical devices has often led to a hue and cry, the most infamous incident being the superbug outbreak in Virginia Mason Hospital and Medical Center in Seattle, Washington in 2013.


The incident involved a widely used duodeno scope made by Olympus. It is a flexible tube inserted in the mouth in order to reach the small intestine.Erasmus Medical Center in the Netherlands experienced an outbreak of a multidrug-resistant infection among 30 of its patients in January 2012, and that’s when the defect came out. The design flaws in the device made it impossible to completely disinfect it.

The incident unleashed a serious threat to the safety of medical devices. Following the incident, it was revealed at least 17 U.S. hospitals experienced similar outbreaks related to these scopes. Adding to it,eight of them did not report these adverse events to the FDA, as required by law. Lack of awareness and training of hospital staff regarding the reporting requirement were cited as the reasons for it.

India too has a sorry state as far as medical devices are concerned. India has struggled with an ambiguous and archaic regulatory framework for the medical devices sector. 75 percent of the medical devices in our country are imported. This leads to substandard imports as well as the production of poor quality medical devices in the country.

However, the Union Budget 2017 saw a respite in terms of norms for the medical devices sector. However, we still have a long way to go.

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