Not all physicians or medical care providers would be able to identify loopholes or issues and help the patients accordingly. Now in this context only with standards, it will be possible to give patients a safe and secure environment.
In terms of ensuring the patient safety, there must be harmonization of the practices and the other requirements to use to enhance technology. These were used for the health of patients. Standards were set to increase competition, increase in revenue and the availability of devices needs to be understood as well.
Standards that are developed must work in liaisons with the current technology. They must not lead the state of technology, however, there can be exceptions made based on the subjective requirements. The standard requirements that are developed need to be published and peer reviewed. These need to be combined with the practical experiences that can be gained from the user community.
Standards that are developed need to have a clear objective and need to be validated by the risk assessment. These must address the essential requirement. The utilization of the resources needs to be limited and must be used wisely. As an ancillary to this statement, these serve as important reference to the decision-making. These must not replace the decision making by the medical devise creators and users.
he governments must take an active role in the participation of the stakeholders. These are used in the setting of the priorities for the standards. The governments must not utilize the voluntary standards in regulatory processes. The government must not be the exclusive agent in the development standards. Except in cases of exceptional conditions where the needs of the people need to be understood as well.