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Pain pumps have become a routine part of many surgical procedures, including plastic surgery. When performing an operation that’s somewhat invasive and disruptive to internal tissues, such as abdominoplasty and breast reduction, surgeons will often finish up by attaching a temporary pain pump to ease the patient’s recovery from plastic surgery. These pumps bathe the surgical site with a continuous flow of pain medication, greatly reducing discomfort for most patients.
Now, the U.S. Food and Drug Administration has made a proactive move you should be aware of if you’re planning plastic surgery or another procedure that might involve a pump for automatic medication purposes.
These devices are termed “infusion pumps” by the FDA, as their use is wider than just as post-surgical pain medication systems. Infusion pumps also deliver insulin for diabetics, chemotherapy for cancer patients and antibiotics for people with serious infections. Noting what it describes as “numerous reports of adverse effects…including serious injuries and deaths” over a period of a few years, the FDA recently launched an “Infusion Pump Improvement Initiative.”
What’s especially notable is that normally the FDA responds to problems with medical devices on a case-by-case basis. But a large number of problems with infusion pumps during the period 2005 through 2009 prompted the FDA to take more aggressive action than usual.
During that four-year period, the agency noted 56,000 reports of “adverse events” with infusion pumps. Manufacturers issued recalls for the devices 87 times during that same time frame to address safety concerns. The majority of the recalls were deemed “Class II,” meaning that use of the device could result in temporary or reversible effects, not likely in serious health consequences. But 14 orders were “Class I” recalls, in which serious health consequences or even death could result from the use of the infusion pumps.
Many different manufacturers were involved, not just one or two. Through its own investigation, the FDA noted that pump failures were most often related to design and engineering deficiencies in user interfaces, software and mechanical and electrical problems. These findings prompted the FDA’s Center for Devices and Radiological Health to develop the Infusion Pump Improvement Initiative, described in a white paper issued in April of this year. You can read the white paper here:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/ucm205424.htm#causes
The Initiative covers three main areas of focus. First, the FDA will impose additional requirements on manufacturers. These include providing more information on the design and engineering of the devices as companies submit for FDA approval. Additional testing will be required as well.
Second, the FDA is now working hand-in-hand with members of the academic community as well as with manufacturers on improvement processes. This means, for instance, that the FDA is offering its extensive software expertise to manufacturers, inviting them to submit code for early detection of programming errors.
Finally, the FDA is working to educate the public about problems with the devices now, before the new improvement measures can be expected to improve the situation. The agency is encouraging health care workers and citizens to learn what to do to help avoid problems and how to report issues with infusion pumps.
If you’re planning plastic surgery, or any treatment that may involve an infusion pump for pain relief or another purpose, you owe it to yourself to invest in understanding these moves the FDA is making on your behalf. Visit the Web site the FDA has created just for this purpose:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/default.htm
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