FALLS CHURCH – As radiology devices used in the treatment of cancer have become more complex, powerful and effective so do the potential problems.
A recent series of New York Times articles have exposed many of the consequences resulting from the erroneous use of radiology devices, and the resulting deaths and severe injuries. For instance, a Philadelphia hospital gave the wrong radiation dose to more than 90 patients with prostate cancer, and a Florida hospital revealed that 77 brain cancer patients had received 50 percent more radiation than prescribed. Some physicians estimate that one out of 20 patients receives lethal doses of radiation.
Diagnostic equipment also can fail, potentially exposing patients to misdiagnosis and mistreatment. Many radiology devices are extremely complex systems composed of hardware and software. Software controls the interaction of hardware, administration of treatment and storage of patient information and results. Systems from one manufacturer must often interact with those of several others. Devices such as CT scanners not only deliver radiation but have complex moving parts to position the patient and deliver radiation accurately.
In radiology products, the most frequent cause of a product safety notification is a problem with software, says Bill Klein, Principal of Noblis Health Innovation’s National RASMAS Center, which tracks all healthcare safety notices. Klein says that in 2009, over 48 percent of radiology recalls concerned software, with hardware problems following up at 38 percent, packaging and regulatory issues composed the remainder of the notices.
Established in 2004, RASMAS helps healthcare facilities track recalled and defective supplies and equipment in 15 different product domains, including biologics, blood products, toys, food, pharmaceuticals, radiology products and tissue. Hospitals use RASMAS to speed recalls and reduce the days of risk that a faulty product might be in use in a hospital. Because of the inherent dangers in radiation, fixing potential errors faster is key.
“The overwhelming majority of accounts that purchase the RASMAS Enterprise edition actively use the radiology domain,” says Cathy Veum, RASMAS, senior manager.
The RASMAS service tracks both official recalls from federal agencies, as well as safety updates. In a typical year, RASMAS releases about 100 to 150 radiology related notices, says Klein. These notices include safety bulletins related to hardware and software problems. The most complex radiology alerts are related to treatment and treatment planning, system operation and data collection.
“The most troubling reasons for alerts we see are those that involve potential misinterpretation or loss of image that would result in repeat studies, additional treatment or incorrect treatment,” says Klein.
One manufacturer accounted for 33 percent of the RASMAS radiology device alerts released in 2009. This does not necessarily mean that manufacturer’s radiology products are less safe. “We see a lot of recalls related to radiology equipment,” says Klein. “The number for any manufacturer may only be a function of the diversity and number of devices sold by that manufacturer and the complexity of those devices” says Klein. “A given manufacturer may also have more robust Quality Control which results in more notices, theoretically making them safer” adds Klein.
A sampling of recent recalls issued by RASMAS include:
- An alert for an angiography system. The reason? If the patient information was not closed out properly before a new patient used the machine, the previous information could be attached to the new patient.
- An alert for certain CT Scanners. Under certain circumstances, the scanners could expose patients to increased radiation during diagnosis and treatment of stroke.
- An alert for a robotic system. The alert was issued because targeting accuracy was “out of specification.”
The hazards are not all in software and dosage; there are mechanical hazards, as well. In 2004, one radiography machine was recalled because of the potential for pinching genitals. A Canadian firm recalled their neurosurgical equipment because screws with non-insulated posts could cause minor burning of patients during high energy MRI usage.
Because of the complexity of the equipment, patients cannot readily assess if the machine that is being used on them is working properly. Consumers who are undergoing radiology treatments can, however, ask their physicians about maintenance procedures, equipment operation and staff accreditation. In addition, patients can ask technicians and staff if there are established procedures to ensure that safety notices are dealt with quickly.
“There’s little the consumer can do,” says Klein. “Ultimately, the responsibility rests with the physician and staff who operate the devices.”
- The National Cancer Institute has a full list of types of radiation therapy, including a Q&A of frequent questions, and definitions of types of treatment.
- The American Cancer Society has an online listing of the effects of radiation therapy.
- The American Society for Radiation Oncology has online resources related to radiation oncology, including a response to The New York Times article.