So Boston Scientific has finally been given the all clear by the US Food and Drug Administration. The company yesterday announced that the agency has officially allowed it to resume the distribution of its defibrillators, after having failed to inform the federal regulators of all the changes that had been made in manufacturing of its best-selling product last month.

It was all over the news when it happened on March 15, Boston Scientific had ceased the shipment and recalled all the unused units of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds) as a result of the firm failing to notify the US FDA about the manufacturing and process changes that had been made to the devices.

As per the US law, manufacturers of medical devices must inform the regulators of any significant changes that have been made to a device, and failing to do is not taken lightly. Medical products like defibrillators are highly critical devices as these are something that actually live inside a patient and are intended to help patients.

The FDA awards approval to medical devices based on several parameters and if there are any changes made to such widely used things, the agency needs to know about it so that it can once again access it, and if found with any problems, can ask the company to change it.

The Boston defibrillators are used by doctors to treatment patients who need regulation of heartbeats. In addition, the device sends electrical pulses to a patient's heart when it senses the coming of a heart attack.

Such a critical device cannot just be changed or experimented with, as even a small error can have devastating effects. And to top it all, you don't even tell anyone!

We hope Boston has learned its lesson and will be careful in future. After all, when you are a company involved with the manufacturing of such critical products, you can never be too careful!