ANNAPOLIS – A Maryland manufacturer’s infant warmer system pops up on a Food and Drug Administration database of medical device problems more than 40 times since 1992, but that doesn’t mean the device is faulty.
Ohmeda Medical in Columbia, which makes the warmer systems, is required by the FDA to report any problems connected with its medical devices, whether the product caused the incident or not.
The warmer, used by hospitals to control the environment around a young Patient, showed up in 45 cases, a very small part of the thousands of reports of possible medical device malfunction filed with the FDA each year.
“You don’t have to be impressed with the numbers,” said Alberto Profumo, director of product assurance at Ohmeda. “They don’t really mean much.”
As part of its responsibility to monitor the safety of all medical products on the market, the FDA requires manufactures to report any malfunction, serious injury, or death that could be related to medical device use. Submitting the report is not meant to imply that the product caused the event or is dangerous in any way.
Millions of medical device reports have been filed since 1992, making Ohmeda a tiny part of the huge pool of information. Ohmeda is one of only a handful of Maryland manufacturers that show up in the records, largely because the state has few medical device producers.
It’s also difficult to draw conclusions from the FDA data because some manufacturers underreport product difficulties, while others err on the side of overreporting.
Reports filed during the first three months of 2000 were recently released by the FDA. The FDA provides information from the reports over the Internet so that anyone interested in researching device problems has access to the records.
FDA regulations are very precise, Profumo said. Its definition of a serious injury may be extreme for people outside of the medical industry.
“We have some cases of babies getting a little redness of skin – that could be caused by medication – but we report it,” he said.
Some of the first reports since 1992 were filed because blisters were found on an infant while in the warmer.
In one case, a 3-day-old infant was placed in the warmer and monitored with a temperature-gauging probe.
“The attending nurse noticed that where the probe had been attached, there was a raised blister on the infant’s skin,” the report said.
An evaluation of episodes similar to that case determined the probe was left for too long in one place on the skin. A baby’s skin is quite delicate and moving the probe to another area was necessary to avoid damaging the skin.
Since July 1997, the company has had to file just two incident reports.
The FDA determines from the reports whether a device should be investigated further.
“Ninety-five percent of the reports we submitted, we never hear back from the FDA,” Profumo said. “The other 5 percent I may get a phone call.”
More than 14,700 reports were filed between January and March, but Maryland manufacturers were involved in only eight cases.
Maryland is likely to have few incidences because the state has fewer medical device makers than states like California.
The eight devices reported by Maryland manufacturers included bandages, a ventilator and a hypodermic syringe.
The two bandages, made by Trinity Laboratories Inc. in Salisbury, were reported because they became unsterilized through user error.
Hospitals, nursing homes, and other medical care centers also are required to report to the FDA any suspected device-related deaths. The 2000 first quarter reports had 242 incidents – less than 2 percent – involving a death.