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Quality And Risk Control Measures In The Medical World

Sep 16th 2015 at 10:51 PM

The population must have heard of the existence of the Food and Drug Administration. It is precisely what it sounds like – a standards control organization that ensures what you’re eating and using passes the safety standards it has set forth. Only when a medical device/foodstuff/drug passes these standards it is allowed to go forward for sales. Also another function of this organization is to help conduct FDA REMS (Food and Drug Administration Risk Evaluation and Mitigation Strategy) to help educate people about the evils of certain potentially harmful but necessary medication (such as medication for seizures). FDA circulates guidance documents that helps the research agencies carry out risk mitigation and education regarding usability and testing of medical devices.

The guide on FDA human factors provides an insight on the device design and optimization by analyzing human factors, testing and validation. The FDA requires every manufacturer of medical devices to conduct a risk analysis to determine any potential harm that may arise from the use of their products. If the results conclude in the risk being medium to high, it is required by the manufacturer to conduct appropriate testing in human factors according to the guidelines. Medical device usability testing is conducted with the help of agencies that have experts in the field and are well-versed with the protocols of the FDA.

This is not all that needs to be monitored in the medical industry. There is a thing called label comprehension studies, which involves the factor of determining whether or not the label of a consumable product appropriately communicates to the user the directions, uses, risks and warning and ingredient information that the product has. This may include inserting information pamphlets inside packages or designing packages in a way that makes this information visibly clear to the buyer. The same agencies that provide human factor studies services also dispense experts that know the how-to of label comprehension study. Drug usability studies determine the level of adherence to label direction of the use of a certain drug or product by the patient. This study is an effective tool to understand whether or not the user understands the directions of use and administration of a particular medication.

The risk evaluation and mitigation strategies identification involves a high level of education to understand and evaluate the potential use of a drug. Consulting services are available to make sure the manufacturers meet FDA standards without fail. The patients prescribed to drugs with potential side-effects need to be educated properly before actual prescriptions about the harms of that drug. The patients need to understand the fact that what they are consuming is necessary but can be potentially dangerous. They need to understand how to identify side-effects arising due to consumption of that drug. This education is included in the REMS activities of the FDA, and must be adhered to in all situations while disseminating things that are associated with medium to high levels of risk.

The FDA ensures user safety in all aspects, and the professionals in this field that do research for enabling a safer environment assist implementation of a danger-free use. Visit to know more about FDA REMS.

About The Author

James Williams is an expert when it comes to Risk Evaluation and Mitigation Strategies aka REMs in relation to the medical industry. He recommends as the name you should be trusting for any information related to medical device usability testing, FDA standards and more.


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