Patient Safety

Radiation medicine with newer capabilities will continue to improve care and save lives; however, safeguards must limit patient harm.

By Cheng B. Saw, PhD

Radiation medicine in the diagnosis and treatment of diseases has proven to be so over whelmingly beneficial that it has become an integral part of modern medicine. The rapid technological advances in radiation-producing equipment, in particular CT scanners and medical linear accelerators, are equally spectacular, yielding high-resolution images for diagnosis and precise dose delivery for radiation treatments.

Americans today receive far more medical radiation than ever before. In fact, the average lifetime dose of diagnostic radiation has increased sevenfold since 1980 and more than half of all cancer patients receive radiation therapy. A study conducted in U.S. emergency departments also indicated that CT scans of pediatric patients have increased fivefold over a 13-year period ending in 2008.¹ Radiation medicine has advanced the quality of patient care and saves countless lives.

CT use

The increased use of CT scans for diagnostic examination is not surprising. This modality has seen amazing advancements over the past decades and offers new clinical capabilities over other modalities, even in scanning children. Today, a whole body of a child can be scanned and examined with exquisite image quality in half a second. The level of accuracy offered by CT scans has significantly improved the quality of pediatric care, making surgical procedure unnecessary.

However, there are concerns regarding the medical necessity, overuse, and lowest dose exposure rate possible since the long-term effects on children may include cancer. For example, a New York Times article pointed to the medical necessity of a "babygram," a full body radiation exposure of an infant.²

Accordingly, multiple efforts are under way to establish Best Practice in Pediatric Radiation Exposure and Standard for CT indications in children.³ In the U.S., a federally funded organization known as the Pediatric Emergency Care Applied Research Network is playing a major role in developing protocols in the use of CT for children.⁴

Along the line of usage and medical necessity, the Medicare claim records indicated that in 2008 there were 75,000 patients receiving double CT scans; one scan used iodine contrast to check for blood flow and the other did not.⁵ The performance of double scans (that will increase radiation exposures to patients) significantly has been contested as unnecessary.

As well, an article that appeared in The New York Times on Oct. 16, 2009, reported CT brain perfusion scans were overdosed at a large well-known institution (Cedar-Sinai Medical Center, Los Angeles) and a small hospital (Mad River Community Hospital, Arcata, in Northern California).⁶ CT brain perfusion scan is a type of imaging technique used in certain urgent situations such as a suspected stroke condition to identify the extent of possible blood clot flow in the brain. The case at the Mad River Community Hospital was particularly disturbing when a child-more vulnerable to radiation-was subjected to more than an hour of CT scans, which should have taken two to three minutes. For whatever reason, the CT scan was performed 151 times on an area that normally takes 25 images.

On the other hand, the overdose incidents at Cedar-Sinai Medical Center were attributed to the hospital's flawed procedures. The chief executive of the institution claimed that the manufacturer could have helped to prevent future errors by improving its internal settings and installing more safeguards.

A subsequent article by the same reporter on July 31, 2010, indicated that the overdoses from CT brain perfusion scans were more widespread than previously reported.⁷ Nationwide, upward of 400 patients were affected in eight hospitals. While the causes were not clear, the blame could be on the shoulders of the techs who use the equipment to perform the procedures or the manufacturer who provides inadequate training.

Even when the procedure is done properly, CT brain perfusion scans will deliver a large dose of radiation, but there is no standard of what constitute too much dose. These events highlight how little the medical profession understands the operation of these scanning devices and the nature of radiation injuries as well as the loose requirements for reporting accidents when detected.

3-D systems

The introduction of 3-D treatment planning systems in the early 1990s had transformed the practice of radiation oncology. The 3-D system allows the visualization of dose delivery in three dimensions, making it possible to design complex treatment techniques such as conformal radiation therapy and intensity-modulated radiation therapy. The availability of fast networks and sophisticated medical linear accelerators facilitate the implementation of these treatment techniques.

However, the American Association of Physicists in Medicine and American Society of Radiation Oncology (ASTRO) expressed concerns that the technological advancements have been so rapid that safeguards and quality assurance are not keeping pace. These concerns led to the organization of a symposium on quality assurance in radiation therapy held in 2007.

Then, front page New York Times articles described radiation therapy incidents in which patients lost their lives or were severely handicapped by radiation treatments. The first of these articles described the events leading to the death of two patients from radiation overdoses: One was caused by computer error in the failure to modulate radiation beam and the other was the result of human failure to place a wedge filter in the radiation beam.⁸ While these errors have the opportunity to be detected, the violation of safety rules has led to the inevitable outcome.

In addition, The New York Times had examined the records of radiotherapy errors reported to the state of New York. The records described 621 mistakes from 2001 to 2008. Most were minor and caused no immediate injury, but it illuminates the underlying problems in radiation therapy. There were 133 occasions where devices used to shape or modulate the radiation beam contributed to patient injury. On 284 occasions, radiation missed all or part of its intended target or treating the wrong body 
part entirely.

Subsequent articles highlighted the vulnerability of patient safeguards with the use of increased complex computer-controlled equipment that delivers higher doses in a short time or few fractions with greater precision than ever before.^9-11 Serious radiation injuries are infrequent, but the technology introduces its own risks of errors in software and operation.

Ensure safety checks

As noted in these articles, many mistakes could have been caught through basic checking protocols, yet there's a realization that the rapid pace of technological improvements has made some safety procedures outdated. In addition, health care institutions are lagging and, at times, failing to provide the necessary financial support to train staff to operate the complex devices and treat the patients safely. The gap between advancing technology and outdated safety protocols leaves medical physicists and radiation oncologists without a clear strategy for maintaining the quality and safety of treatment.

The articles noted here also captured the attention of the public, professionals in radiation oncology, federal agencies, and Congress. A congressional hearing, "Medical Radiation: An Overview of the Issues," was conducted under the chairmanship of Congressman Henry A. Waxman, chairman of the House of Representatives Committee on Energy and Commerce on Feb. 26, 2010. Leaders from the professional group in this discipline called for more standardized and comprehensive methods of overseeing medical radiation.¹²The need for licensure and requirements to report errors and the penalties for making errors were noted as non-existent or not enforced in many states.

Action plan

To address the heightened concerns regarding errors and malfunctions in radiation oncology, a meeting was convened in June 2010. ASTRO also responded to the challenge of improving quality and reducing errors by developing a six-point action plan:

1. Create an anonymous national database for event reporting.

2. Enhance and accelerate the ASTRO/ACR Practice Accreditation Program.

3. Expand education and training programs to include intensive focus on quality and safety.

4. Develop tools for cancer patients to use in discussion with radiation oncologists.

5. Accelerate development of the IHE-RO (Integrating the Healthcare Enterprise-Radiation Oncology) program.

6. Advocate for passage of the CARE (Consistency, Accuracy, Responsibility, Excellence in Medical Imaging and Radiation Therapy) act.

Radiation medicine with newer capabilities will continue to improve the quality of patient care and save lives. However, safeguards must be in place to limit patient harm. Best practice with lowest radiation exposure for both diagnosis and therapy and the standard indications for use of each radiation modality should be established to avoid unnecessary use or overuse.

While new technology allows physicians to more accurately attack tumors, the complexity of the planning and dose delivery systems creates new venues for errors through software flaws, faulty programming, poor quality assurance, and outdated safety procedures, as well as inadequate staffing and training. The culture of patient safety requires the support from all team members in the diligent examination and alertness of possible harm by working together to eliminate every possible error. Greater oversights for medical radiation at the institutional, state, and/or federal levels are necessary, not only to serve as a clearing house, but also provide a means of information dissemination nationwide. 

References

1. Larson DB, Johnson LW, Schnell BM, Goske MJ, Salisbury SR, Forman HP. Rising use of CT in child visits to the emergency department in the United States, 1995-2008. Radiology. 2011;259(3):793-801.

2. X-Rays and unshielded infants. New York Times, Feb. 27, 2011.

3. Image Gently Campaign. Available from: www.pedrad.org/associations/5364/ig.

4. Pediatric Emergency Care Applied Research Network. Available from: www.pecarn.org.

5. Medicare claims show overuse for CT scanning. New York Times, June 18, 2011.

6. Radiation overdoses point up dangers of CT scans. New York Times, Oct. 16, 2009.

7. Hospital stroke scans causing radiation overdoses--patient face serious health risks. New York Times, Aug. 1, 2010.

8.   Radiation offers new cures, and ways to do harm. New York Times, Jan 23, 2010.

9.   As technology surges, radiation safeguards lag. New York Times, Jan 26, 2010.

10.     A pinpoint beam strays invisibly, harming instead of healing. New York Times, Dec. 28, 2010.

11.     Radiation errors reported in Missouri. New York Times, Feb. 25, 2010.

12.     At hearing on radiation, calls for better oversight. New York Times, Feb. 27, 2010.

Cheng B. Saw, PhD, is chief physicist at Northeast Radiation Oncology Centers, Scranton, Pa.