A lot has happened since the NY Times publication of its eye-opening 2-part series (Bogdanich 2010a and 2010b) on the hazards of radiation (see our February 2, 2010 Patient Safety Tip of the Week “The Hazards of Radiation”). Both Congress and the FDA have opened investigations into radiation safety issues. NIH is requiring imaging vendors to include dose-tracking technology in scanners purchased by NIH so that doses can be catalogued in a central database or EMR and be provided to patient’s personal medical records. The manufacturers of imaging equipment (MITA or the Medical Imaging and Technology Allicance) have issued new principles on radiation safety and begun an initiative to establish radiation dose safeguards. These include comparing the dose of radiation for a planned scan against a dosage threshold established by the hospital, above which an alert will be generated. Others include development of a national dose registry for tracking dose levels of patients across the US and integration of dosing information into EMR’s. And others apply to accreditation, training and education of all workers in imaging and better reporting of radiation-related incidents.
All this occurs as a CDC report showed the rates in the US of office visits or hospital outpatient clinic visits in which MRI, PET or CT scans were ordered or performed tripled between 1996 and 2007. And the number of advanced imaging studies ordered by or performed in emergency departments increased four-fold during the same time period.
Largely in response to the series of radiation overdoses during CT scanning that had occurred at Cedars Sinai and other hospitals, the FDA unveiled its “Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging”. The FDA has planned a public meeting on March 30-31, 2010 to discuss reduction of unnecessary radiation exposure to patients during CT scanning, nuclear imaging, and fluoroscopy. It issued a white paper that outlines some planned recommendations. One will be establishment of requirements for manufacturers to incorporate safeguards into their equipment design, labeling and user training. This might include recording and displaying radiation dose with alerts for users when dose exceeds usual levels. The second major element of the initiative will be to partner with accrediting organizations to develop standards that ensure appropriate quality improvement and patient safety programs are utilized by all facilities using these diagnostic imaging modalities. Thirdly they will collaborate to develop diagnostic reference levels and a national radiation dose registry. Similarly, they recommend development of patient registry tools, coupled to electronic medical records, that would provide cumulative dosages of radiation to be made available when a practitioner is considering ordering another imaging study. They recommend continued efforts by multiple organizations to develop appropriateness criteria for various imaging studies. And, lastly, they plan to increase patient awareness of the issues involved in radiation and imaging and recommend development of tools that patients themselves can use to track their personal radiation imaging history.
Meanwhile, further instances of radiation-induced injury have continued to appear. A recent report from a Missouri hospital noted that 76 patients had been overradiated during procedures involving their brain stereotactic system. Most striking is the fact that the cases spanned the time period 2004 to 2009. An original programming error using an incorrectly calibrated measurement apparently led to the overdoses. But the problem was not identified until 5 years later when a second radiation physicist was undergoing training on the system. The hospital system is in the process of notifying all the patients affected. But the case highlights the fact that many hospitals lack quality improvement systems for monitoring doses of radiation actually delivered.
While most of the recent flurry of activity has related primarily to CT scanning and radiation therapy, a new article highlighted the hazards of fluoroscopy (Balter et al 2010). The article notes that current guidelines on fluoroscopy-related skin injuries are over 16 years old and that we have seen expanded use of fluoroscopy as interventional procedures have grown. A key point is that the radiation-induced skin changes may not occur for a month after the procedure and that both patient and physician often don’t make the connection back to the fluoroscopic procedure. Patients often get unnecessary (even dangerous) skin biopsies and inappropriate treatments. Two important points are informing patients they have received high doses of radiation and actually making followup contact with them in the future. Ensuring appropriate training and privileging of physicians performing fluoroscopy is key. You may be surprised to find out all the physicians in your organization who may be peforming fluoroscopy. While you anticipate it will mainly be radiologists and cath lab personnel, we have been surprised at the number of emergency room physicians, orthopedic surgeons, anesthesiologists and others who have done fluoroscopy. Many of the latter have never had appropriate radiation safety training. And remember that in those circumstances, not only are patients at risk but staff may be inadvertently exposed to radiation.
Prior to the NY Times series on injuries from radiation therapy, an outstanding article appeared in the journal Radiotherapy & Oncology (Scorsetti et al 2010). Italian researchers performed a FMEA (failure mode and effects analysis) of their entire process of radiation therapy. A multidisciplinary team mapped out all the steps in the workflow of performing radiation therapy (including going out and observing to identify some steps that may have been overlooked during brainstorming), then identified things that could go wrong and weighted scores by the likelihood they could go wrong. They then focused on improving processes in those areas considered most vulnerable. It is well worth your while to read this comprehensive work and use it as a model for performing a FMEA of your own.
In our January 12, 2010 Patient Safety Tip of the Week “Patient Photos in Patient Safety” we said we couldn’t find any unintended consequences of patient photographs in the medical literature. Well, the Scorsetti group did find one! During their focus on potential misidentification of patients they noted that a photo of each patient had been added to the medical record. However, these photos were often not representative of the patient’s appearance at the time of treatment so staff tended not to rely on the photographs.
Bogdanich W. The Radiation Boom. Radiation Offers New Cures, and Ways to Do Harm. New York Times. January 24, 2010
Bogdanich W. The Radiation Boom. As Technology Surges, Radiation Safeguards Lag.
The New York Times. January 26, 2010
ACR Press Release. NIH Takes Step to Assess Any Possible Risk Associated With Low-Dose Radiation Exposure. February 1, 2010
MITA. Medical Imaging Manufacturers Unveil Eight Key Principles to Reduce Unnecessary Radiation Exposure and Medical Errors. Plan addresses CT and radiation therapy. February 12, 2010
CDC. National Center for Health Statistics. Health,United States, 2009 with Special Feature on Medical Technology.
FDA. Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging.
FDA. White Paper: Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging.
76 patients overradiated at Missouri hospital. HealthImaging.com. February 25, 2010.
Balter S, Hopewell JW, Miller DL, Wagner LK, Zelefsky MJ.
Fluoroscopically Guided Interventional Procedures: A Review of Radiation Effects on Patients’ Skin and Hair
Radiology 2010; 254: 326-341
Scorsetti M, Signori C, Lattuada P, Urso G, Bignardi M, Navarria P, Castiglioni S, Mancosu P, Trucco P. Applying failure mode effects and criticality analysis in radiotherapy: Lessons learned and perspectives of enhancement.
Radiother Oncol. 2010 Jan 27. [Epub ahead of print]