The initiative will address safety problems associated with infusion pumps by requiring manufacturers to collect more information about the level of data in pre-market infusion pump products, including providing additional information on design and engineering and conducting additional testing and analytics that need to be done.


“To any company, the bar to enter has been raised considerably,” says Nelson Patterson, senior director of Baxter's global infusion systems business. “If you have a new product, or you make a change to an existing product, even if it’s considered minor, it will require clinical evidence that you are improving the safety and the capability of the product. That’s a time delay and a huge barrier to bringing new products to the market.”

Advancements abound
Newer automated tools have emerged and are beginning to play a role in infusion pumps as some pumps have the capability of integrating patient monitoring and additional parameters such as the patient’s age or clinical condition.

“What we are seeing in the infusion pump market is a lot of conversations surrounding meaningful use,” says Symeria Hudson, vice president, medication management systems for Hospira in the U.S. “The Obama administration launched a big campaign in 2009 focused on the adoption of electronic health records and there are opportunities for pump companies, like Hospira, to really be inclusive in the definition of meaningful use.”

In its goal to shape the parameters of meaningful use in the industry, Hospira has focused its efforts on developing pumps with more interoperability and auto-programming functions.

“We look at how our devices can be integrated within a hospital’s electronic medical records and bar code point-of-care administration systems, which allows for auto-programming for specific patient orders back to IV devices,” Hudson says. “We understand the importance of having a solution that provides customers with these capabilities.”

B. Braun has recently introduced its Outlook Safety infusion system, which has a barcode scanner built into it and has the option for a handheld scanner to be attached.

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