Dr Kohout's Plastic Surgery Blog

Proposed Legislation to Tighten Safety on Medical Devices

Mark Kohout - Sunday, December 15, 2013

Parliament has agreed to more vigilant monitoring systems and certification procedures to ensure adherence to safety standards and the traceability of medical devices. MEPs also refined outlines for ethical requirements for devices used, for example, during pregnancy and DNA testing.

The proposed legislation attempts to improve access to information for staff and patients and traceability of devices. Recently a number of patients with possibly defective implants were untraceable. MEPs want to introduce "implant cards" and for patients to register so that in the event of a defected device, other patients can be informed.

Currently, assessors of devices use subcontractors. MEPs want a permanent team of assessors who operate in - house.

Some medical instruments, e.g. stethoscopes, are frequently reused. Many instruments marked single use are still being used multiple times after being disinfected. MEPs contend that practitioners and institutions who reuse these items must be held liable and ensure traceability of the device. Also, a list should be complied detailing what should not be reused.

The plenary are negotiating with Council. Agreements will then be put to a vote in the Public Health committee before approval by the full House.

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