- Jul 16, 2001
- 17,969
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TRENTON, N.J. (AP) -- For eight months during his infancy, Sean Van Duyn gagged, retched and vomited daily. Now 6, the Winter Haven, Fla., boy still can't eat or drink by mouth, instead being fed by a permanent tube in his belly.
Beset by multiple medical problems in his first months, the boy had to have a breathing tube inserted through a hole cut in his neck. The gagging began and continued until his mother, Susan, discovered the tube was misshaped at the end and had been poking the back of his throat the whole time. The tube was replaced, but by then Sean's developing brain was programmed not to swallow; he still cannot.
The family alleged the injury occurred because the plastic breathing tube's tip had been bent during "reprocessing'' -- cleaning and heat sterilization -- done at an Orlando hospital even though the tube was labeled for single use only. They won a confidential settlement from the hospital.
The case has fueled the debate over the safety of reusing surgical blades, forceps and other medical devices. The practice was routine until a couple decades ago, when stronger plastics enabled manufacturers to start making devices designed for single use to cut costs and prevent infection spread in the era of AIDS.
Then hospitals, and eventually specialized companies, started "reprocessing'' single-use devices, cutting device costs by about half -- without patients' knowledge.
Federal regulators say reprocessing is safe, but original device manufacturers say they can't guarantee recycled products will work correctly -- and that they are wrongly blamed for malfunctions and patient harm caused by reprocessing.
A federal law taking effect Tuesday, requiring reprocessors to put their company name on recycled devices as well as the packaging, could help determine who's at fault when problems occur. For devices too small to mark, detachable stickers could be transferred to the patient's chart.
TRENTON, N.J. (AP) -- For eight months during his infancy, Sean Van Duyn gagged, retched and vomited daily. Now 6, the Winter Haven, Fla., boy still can't eat or drink by mouth, instead being fed by a permanent tube in his belly.
Beset by multiple medical problems in his first months, the boy had to have a breathing tube inserted through a hole cut in his neck. The gagging began and continued until his mother, Susan, discovered the tube was misshaped at the end and had been poking the back of his throat the whole time. The tube was replaced, but by then Sean's developing brain was programmed not to swallow; he still cannot.
The family alleged the injury occurred because the plastic breathing tube's tip had been bent during "reprocessing'' -- cleaning and heat sterilization -- done at an Orlando hospital even though the tube was labeled for single use only. They won a confidential settlement from the hospital.
The case has fueled the debate over the safety of reusing surgical blades, forceps and other medical devices. The practice was routine until a couple decades ago, when stronger plastics enabled manufacturers to start making devices designed for single use to cut costs and prevent infection spread in the era of AIDS.
Then hospitals, and eventually specialized companies, started "reprocessing'' single-use devices, cutting device costs by about half -- without patients' knowledge.
Federal regulators say reprocessing is safe, but original device manufacturers say they can't guarantee recycled products will work correctly -- and that they are wrongly blamed for malfunctions and patient harm caused by reprocessing.
A federal law taking effect Tuesday, requiring reprocessors to put their company name on recycled devices as well as the packaging, could help determine who's at fault when problems occur. For devices too small to mark, detachable stickers could be transferred to the patient's chart.
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