The U.S. Food and Drug Administration (FDA) plays a critical role in keeping consumers safe. There is a reasonable expectation that a product that is bought at a store will be safe for use. That expectation is even more secure when it comes to products that are used by medical professionals in critical health care processes. A patient does not wander through a store to select which medical products are used in their care. From hip implants and needles, to medication and IV pumps, patients rely on the choices of their doctors and care of regulatory agencies like the FDA to ensure that dangerous products are not allowed.
Our entire caregiving process is based on this trust. That is why we must be incredibly vigilant about holding designers and manufacturers accountable when products actually harm patients unnecessarily. In the aftermath of dangerous products, medical device lawsuits are common to ensure that accountability is provided and those affect receive redress.
Yet, ideally the damage would be prevented altogether. That is where regulatory agencies are in control. It is critical that the FDA act aggressively to ensure product manufacturers make choices, if necessary, so that dangerous products are pulled from use in a timely manner.
Dangerous IV Pumps
For example, recently the FDA issued another warned to a company that produces a line of IV pumps. As reported in Chicago Business, Hospira, Inc. received a letter from the Administration two weeks ago which included findings from the FDA’s inspection of the company’s headquarters earlier in the year.
The problems included in the letter mostly relate to serious concerns about the safety of pump designs. On top of that, however, the FDA was concerned about the lack of sufficient protocols in place to take “corrective and preventative” action as part of an overall safety plan. There were also concerns about lack of proper reporting following adverse events related to products that the company makes.
In addition, the findings included some worrisome flaws, including concerns about the company’s planned phase out of IV pumps like the Symbiq, GemStar, and others. The company plans to replace those pump with “remediated Plum A+ pumps.” This entire process will cost upwards of $350 million, and FDA officials are unsure of the ultimate effect on patient safety.
Profits Over Patients – Always Unacceptable
Obviously many varied business decisions factor into choices by companies like Hospira. The business of medical device design and manufacture is quite complex, and it is easy to get lost in the details. However, the underlying principle of patient safety must be prioritized first, above all else. While any consumer product can cause harm, those created specifically for medical care pose an increased risk of serious adverse consequences when they are not designed with safety in mind or manufactured improperly.
We have many examples of dangerous products that are not pulled from the market quickly enough (like DePuy hip implants), allowing more patients to be harmed than necessary. We should never allow that to happen again, and so it is encouraging to see the FDA act with vigilance in mind.
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