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Rumor Control: Don’t be misled by misinformation
Check the source and understand the intent behind the post
Misinformation is information that is spread intentionally or unintentionally, that is false, inaccurate, or misleading according to the best available evidence at the time. Consider the last few years during the pandemic when scientific data was questioned, and all types of remedies were rapidly disseminated on the internet. The growing spread of rumors, misinformation and disinformation about science, medicine, and the FDA, can put patients and consumers at risk. Science is designed to evolve, and recommendations may change when there is deeper understanding of the issue. Misinformation often elicits an emotional response and may at first appear truthful when posted out of context, according to an FDA publication.
How you can separate truth or science from fiction
Some folks take an IFU as gospel. Let’s consider some examples to better understand what we mean by misinformation and how it can be interpreted as a requirement. If you were to purchase a car, no one would require you to use only GM fuel. If you purchase a Maytag washer, is anyone acquainted with Maytag detergent? No, it doesn’t exist. Nevertheless, in healthcare, an IFU will often state that the manufacturer’s detergent should be used in their washers and by implication hear “must be used” or told “can void the warranty.” Here’s one that is close to home. A sterilizer manufacturer may have established weight limits for marketing purposes or to sell their product, when in fact the very same company validated containers with significantly higher weight in their sterilizer.
What will Joint Commission say if we don’t follow the IFU to the letter
Manufacturers are responsible for developing IFUs to meet regulatory requirements and users refer to them for guidance. According to the Medical Device Regulation, the term “instructions for use” refers to the information provided by the manufacturer to inform the user of a device’s intended purpose and proper use, and of any precautions to be taken. It is part of risk management and enables the user to use devices safely and avoid errors. Nonetheless, an IFU can also be a marketing tool, to promote a manufacturer’s ancillary products or consumables. Understanding what The Joint Commission says may correct a misconception. “The Joint Commission expects that when conflicts with the manufacturer recommended instructions or products are identified, the organization contacts the manufacturer's technical services to resolve these conflicts. This resolution should also include contacting the manufacturer of the alternative product, if applicable, to determine if they can provide additional information regarding compatibility.”
What can we do when we hear misinformation
The FDA has provided information that can help us identify and address misinformation. Click here to read more.
- Identify misinformation
- Check the source and cross check with reliable sources
- Use science and critical thinking to make choices
- Direct folks to a reliable source
- Don’t contribute to the spread of misinformation
- Request the FDA 510k or an independent validation study
Trust science, it has given us some of humanity’s greatest medical achievements. Don’t take my word for it, check out what the FDA has to say. There may be multiple options that can be considered during policy development or regulatory decision-making.
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