FDA photo comparing
(left) the affected plug
with its black plastic bridge
to the unaffected plug (right)
(left) the affected plug
with its black plastic bridge
to the unaffected plug (right)
FDA Warning on Medical Equipment Fires
October 21, 2009
by Brendon Nafziger, DOTmed News Associate Editor
The FDA released a warning October 19th that possibly defective plugs could cause fires, but the company making the plugs believes it's probably a result of the rough-and-tumble nature of hospitals.
The warning follows voluntary recalls issued by Hospira on August 14 and Abbott on September 4 after the companies received at least 122 reports of sparking, charred bits and fires from machines using plugs the FDA says were made by the Electri-cord Manufacturing Company, based in Westfield, PA.
The cords affected have a black plastic bridge, named a Taller bridge after its original German manufacturer, between the blades. The FDA says if the bridge is burnt, bent or cracked, it should be replaced as soon as possible without jeopardizing patient safety or interrupting treatment.
Cord-maker responds
Electri-cord, which sources the plastic bridges for some of their plugs, stands by their equipment.
"We don't consider it a product defect, we don't consider it a manufacturing defect," Dennis MacDonald, general manager of Electri-cord, tells DOTmed News. "We consider it abuse in the environment these are used in."
MacDonald notes that his company receives weekly U/L inspections -- from the agency that governs quality control in his industry -- and his company has never had process or factory problems. "The U/L reviews all our test records every week, and sends our cords back to U/L labs for more testing. We've never had an issue," he says. And he mentions that Abbott and Hospira have been consulting with his company to find out what's going wrong.
MacDonald says his company has sold over two million of the cords since 2003, and have only had reports of around 26 defects. "That's 13 parts per million defects," he says, noting that anything below 60 per million is considered world class.
MacDonald believes that though the cords meet stringent U/L requirements for hospital use, hospitals are inherently brutal places: when hospital beds are raced from room to room, cords are hurriedly unplugged and the frequent movement of heavy equipment can crush or deform even the most exactingly crafted blades on the plug.
"Blades in hospital cords are solid brass. I mean solid. We get cords where those brass blades are bent at a 90-degree angle. It takes hundreds of pounds of force to do that. It's uncanny to see the condition of some of the cords we get back," he says. "You'd think they were run over by a steam roller."
When asked how hospitals could avoid cord damage, MacDonald recommends doing a "root cause analysis," and he points to Europe, where several years ago regulators suggested moving outlets or receptacles up about four feet higher on the wall. That way, "when the bed is shoved against the wall, the plug isn't behind it," MacDonald says.
Although he says his cords are often fashioned to meet the rigors of hospital and even military uses, "You can only go so far with PVC, plastic and metal."
What You Should Do
If a medical device that uses a power cord with a black plastic bridge has bent or cracked prongs, an outer sheath that is visibly burnt, black residue, or signs of excessive wear and tear, the FDA recommends the following actions:
--A contingency plan to prevent any disruption of patient care.
--Refrain from using the device with the affected power cord as soon as possible, without jeopardizing patient care.
--Contact the medical device manufacturer or sales representative to report the power cord failure and request appropriate replacement or repair.
--Submit a report to the Food and Drug Administration in the "Reporting Problems" section (accessible from the Initial Communication page).
The FDA says personnel in health care facilities should follow protocols for handling equipment malfunctions as required by their respective facilities.
If a device manufacturer has products that have a power cord manufactured by Electri-Cord, or if a manufacturer has received complaints of device malfunction associated with sparking, charring, or fires from the power cords, the manufacturer should:
--Evaluate the medical device to determine whether the power cord is the source of any problems associated with sparking, charring or fires.
--Report events to FDA on FDA Form 3500A, for any complaints that meet the requirements stated in 21 CFR, Part 803 "Medical Device Reporting."
--Perform appropriate voluntary correction and/or removal action as stated in the requirements under 21 CFR, Part 806, "Reports of Corrections and Removals."
Read more:
FDA Alert: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm187117.htm
FDA Initial Communication: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm187078.htm
Edit this story
Astrid Fiano contributed to this report
The warning follows voluntary recalls issued by Hospira on August 14 and Abbott on September 4 after the companies received at least 122 reports of sparking, charred bits and fires from machines using plugs the FDA says were made by the Electri-cord Manufacturing Company, based in Westfield, PA.
The cords affected have a black plastic bridge, named a Taller bridge after its original German manufacturer, between the blades. The FDA says if the bridge is burnt, bent or cracked, it should be replaced as soon as possible without jeopardizing patient safety or interrupting treatment.
Cord-maker responds
Electri-cord, which sources the plastic bridges for some of their plugs, stands by their equipment.
"We don't consider it a product defect, we don't consider it a manufacturing defect," Dennis MacDonald, general manager of Electri-cord, tells DOTmed News. "We consider it abuse in the environment these are used in."
MacDonald notes that his company receives weekly U/L inspections -- from the agency that governs quality control in his industry -- and his company has never had process or factory problems. "The U/L reviews all our test records every week, and sends our cords back to U/L labs for more testing. We've never had an issue," he says. And he mentions that Abbott and Hospira have been consulting with his company to find out what's going wrong.
MacDonald says his company has sold over two million of the cords since 2003, and have only had reports of around 26 defects. "That's 13 parts per million defects," he says, noting that anything below 60 per million is considered world class.
MacDonald believes that though the cords meet stringent U/L requirements for hospital use, hospitals are inherently brutal places: when hospital beds are raced from room to room, cords are hurriedly unplugged and the frequent movement of heavy equipment can crush or deform even the most exactingly crafted blades on the plug.
"Blades in hospital cords are solid brass. I mean solid. We get cords where those brass blades are bent at a 90-degree angle. It takes hundreds of pounds of force to do that. It's uncanny to see the condition of some of the cords we get back," he says. "You'd think they were run over by a steam roller."
When asked how hospitals could avoid cord damage, MacDonald recommends doing a "root cause analysis," and he points to Europe, where several years ago regulators suggested moving outlets or receptacles up about four feet higher on the wall. That way, "when the bed is shoved against the wall, the plug isn't behind it," MacDonald says.
Although he says his cords are often fashioned to meet the rigors of hospital and even military uses, "You can only go so far with PVC, plastic and metal."
What You Should Do
If a medical device that uses a power cord with a black plastic bridge has bent or cracked prongs, an outer sheath that is visibly burnt, black residue, or signs of excessive wear and tear, the FDA recommends the following actions:
--A contingency plan to prevent any disruption of patient care.
--Refrain from using the device with the affected power cord as soon as possible, without jeopardizing patient care.
--Contact the medical device manufacturer or sales representative to report the power cord failure and request appropriate replacement or repair.
--Submit a report to the Food and Drug Administration in the "Reporting Problems" section (accessible from the Initial Communication page).
The FDA says personnel in health care facilities should follow protocols for handling equipment malfunctions as required by their respective facilities.
If a device manufacturer has products that have a power cord manufactured by Electri-Cord, or if a manufacturer has received complaints of device malfunction associated with sparking, charring, or fires from the power cords, the manufacturer should:
--Evaluate the medical device to determine whether the power cord is the source of any problems associated with sparking, charring or fires.
--Report events to FDA on FDA Form 3500A, for any complaints that meet the requirements stated in 21 CFR, Part 803 "Medical Device Reporting."
--Perform appropriate voluntary correction and/or removal action as stated in the requirements under 21 CFR, Part 806, "Reports of Corrections and Removals."
Read more:
FDA Alert: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm187117.htm
FDA Initial Communication: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm187078.htm
Edit this story
Astrid Fiano contributed to this report