Archive for January, 2010

A Look at the Safety of Radiology Devices

Friday, January 29th, 2010
Poster promoting diagnosis and treatment for cancer, Feb. 2 1939, Work Projects Administration Poster Collection, Library of Congress.

A Depression-era poster promoting treatments for cancer, Feb. 2, 1939. Since that time there have been vast advances and improvements in the effectiveness of radiation oncology. From the Work Projects Administration Poster Collection, Library of Congress, Washington, D.C.

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.”

Further Resources

Headlines: ICD Benefits and Risks Studied by HHS, Cardiologists

Friday, January 29th, 2010

WASHINGTON, D.C. - A $3.5 million research project will study the long-term benefits and risks of implantable cardioverter defibrillators, or ICDs, in patients at risk of death from ventricular fibrillation. The study will be done by the Department of Health & Human Services’ (HHS) Agency for Healthcare Research and Quality (AHRQ) and the American College of Cardiology (ACC), the two groups said in a press release. The project is being conducted in cooperation with the National Heart, Lung, and Blood Institute, part of HHS’ National Institutes of Health. (more…)

Headlines: Accrediting Organization Seeks Best Practices

Thursday, January 28th, 2010

URAC LOGOWASHINGTON, D.C. – URAC, the nonprofit accrediting organization, has issued a call for entries for its 2010 Best Practices Awards in Health Care Consumer Empowerment and Protection. The awards hope to find companies that are advancing the role of consumers as active participants in health care.

(more…)

Commission Issues Warnings on Maternal Childbirth Deaths

Wednesday, January 27th, 2010
Mark Chassin, President of Joint Commission

Mark Chassin, President of Joint Commission

OAKBROOK TERRACE, Ill.- Pre-existing medical conditions such as high blood pressure are putting women at greater risk for death during or shortly after pregnancy, according to a Joint Commission Sentinel Event Alert issued today.

Current statistics from the Centers for Disease Control and Prevention show that there are 13.3 maternal deaths per 100,000 live births, well over the target of 3.3 maternal deaths per 100,000 live births set as part of the U.S. government’s Healthy People 2010 initiative. Common preventable causes that lead to maternal deaths include uncontrolled high blood pressure, undiagnosed fluid build-up in the lungs of women with pre-eclampsia, failure to pay attention to vital signs after a Cesarean section, and hemorrhage following a Cesarean section.

“It is a profound tragedy whenever a mother dies in childbirth. Fortunately, these are rare events,” said Mark R. Chassin, M.D., M.P.P., M.P.H., president, The Joint Commission, in a press release.

To prevent pregnancy-related deaths and illness, the Commission suggests that hospitals:

  • Educate physicians and other caregivers about underlying conditions such as high blood pressure, diabetes or morbid obesity that may put women at risk if they become pregnant.
  • Use specific protocols to treat pregnant women who have, for example, experienced a change in vital signs, hemorrhage or pre-eclampsia.
  • Train emergency room staff to consider whether female patients may be pregnant or recently pregnant.

For women who are identified as being at high risk because of existing conditions such as high blood pressure, diabetes or morbid obesity, the Alert calls for referrals to experienced prenatal care providers who can provide specialized services. In order to avoid pulmonary embolism, The Joint Commission urges hospitals to make pneumatic compression devices available to high-risk patients undergoing a Cesarean section. Finally, hospitals are urged to evaluate whether pregnant women who are at high risk for dangerous blood clots (thromboembolism) should receive a special dosage of blood thinner after giving birth.

The standards require hospitals to have a process for recognizing and responding as soon as a patient’s condition appears to be worsening, and to develop written criteria for early warning signs that a patient’s condition is deteriorating. The standards also address staff response to concerns about a patient’s condition and educating patients and families about how to get help if they have concerns.

Much of the information and guidance provided in these Alerts is drawn from the Joint Commission’s Sentinel Event Database, a voluntary reporting systems for serious adverse events. The complete list and text of past issues of Sentinel Event Alert is at http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/.

New Research Sought on Healthcare Supply Chain

Tuesday, January 26th, 2010

CHICAGO – The Association for Healthcare Resource & Materials Management, better known as AHRMM, has created new research consortium focused on health sector supply chain research, the Academic Council for Healthcare Supply Chain Research.

The council evolved from a symposium in the fall of 2009, where 14 academics gathered in Chicago to identify the most pressing healthcare supply chain issues.

Eugene Schneller, Professor at the W. P. Carey School of Business, Arizona State University, and Leroy Schwarz, Professor, Krannert School of Management, Purdue University are the co-chairs. The group plans to meet annually, but will share syllabi, white papers, articles, and research papers on an ongoing basis. AHRMM will serve as host, sponsor, and convener; publications will be shared through AHRMM’s Knowledge Center.

For more information: Academicians and Institutions promoting research interested in working with the council should contact Leroy Schwarz, LSchwarz@purdue.edu. The Association for Healthcare Resource & Materials Management, a a personal membership group of the American Hospital Association, is the leading national association for executives in the healthcare resource and materials management profession. Founded in 1962, AHRMM prepares its members to contribute to the field and advance the profession through networking, education, recognition, and advocacy. See www.ahrmm.org.

News Roundup: E. coli Reduction, Sport Safety and Safety Awards

Tuesday, January 26th, 2010

FALLS CHURCH - A roundup of today’s headlines in the field of health safety and recall:AvidBiotics Logo

  • St. Paul, Minn.-basd Ecolab Inc. is collaborating with San Franciso-based AvidBiotics Corp. to jointly develop a new technology to reduce the presence of the pathogen E. coli O157:H7 in red meat products. The company also said it will work with the Winston-Salem, N.C. based company C Change Surgical LLC to license products that maintain consistent body temperature of patients.
  • This February, the American Association of Orthodontists will launch a campaign to encourage mouth guard usage and sports safety with NFL rusher Emmitt Smith.
  • St. Joseph’s Regional Medical Center in Paterson, New Jersey recently opened the region’s first dedicated Geriatric Emergency Department. Geriatric Emergency departments  have special protocols; for instance any patient who takes five or more prescription medications daily receives a consult with a pharmacist.
  • At the University of Rochester Medical Center Board’s annual meeting, Chairman Ron Zarella presented 2009 Excellence Awards, including two awards related to patient safety. A “Team Excellence” award was presented to the hospital’s Central Line Infection Improvement Project group, which has worked diligently to help eliminate catheter-associated bloodstream infections. This team pored over research and developed a simple, cost-effective checklist of best practices for catheter care. The team includes Mike Apostolakos, M.D., F.C.C.P.; Mary Wicks, R.N., M.P.A., NEA-BC,; Paul Graman, M.D.; Patricia Reagan, Ph.D.; Jan Schriefer, Dr.P.H.; E. Kate Ireland, R.N., M.S.N.; JoAnn Popovich, M.S., R.N., NE-BC; and Nancy Adair, M.S., R.N. The 2009 Board Excellence Award in the Clinician category was presented to Lisa Saubermann, Pharm.D., an associate director of Clinical Pharmacy Services whoplayed a key role in developing and executing drug safety initiatives.


Five New Safety Ideas: Foldable Traffic Cones, Safety Silicon

Monday, January 25th, 2010

iPhone MedlineA roundup of some new ideas related to health safety in the news headlines this week; click on the underlined items for the actual links:

  1. Packable Traffic Cones: Foldable traffic cones, first developed for highway construction, have found a new use with first responders. The cardboard DisposaCone, which folds, can be stuck on pavement in the event of a car accident or any emergency. Because it folds, it takes up less room in emergency vehicles, and reduces reliance on flares.  See www.disposacone.com (more…)

Headlines: California Collaborates for Patient Safety, Minnesota Adverse Events

Friday, January 22nd, 2010

Gene Grigsby, NHF; Leslie Margolin, president, Anthem Blue Cross; Art Sponseller, HCNCC; Jim Barber, HASC; and Steve Escoboza, HASD&IC

Gene Grigsby, NHF; Leslie Margolin, president, Anthem Blue Cross; Art Sponseller, HCNCC; Jim Barber, HASC; and Steve Escoboza, HASD&IC

LOS ANGELES - Anthem Blue Cross, along with California’s three regional hospital associations and the National Health Foundation announced a 3-year, $6 million dollar effort to improve patient safety entitled Patient Safety First… a California Partnership for Health. The Jan. 19 launch at the Ronald Reagan UCLA Medical Center established a system where California hospitals would share information and best practices to reduce infections and improve patient care.

The effort would build upon groups like The Bay Area Patient Safety Collaborative, Southern California Patient Safety Collaborative and the March of Dimes. Areas of interest include perinatal care, sepsis, hospital acquired infections, ventilator associated pneumonia and catheter associated urinary tract infections. Data will be collected from participating hospitals, and benchmarks will be established to enable the success of the program in monitoring and reporting on lives saved, quality outcomes and cost reductions.

Other Health Safety and Recall News headlines include:

  • The Minnesota Department of Health released its annual adverse health events report. In it, the total number of accidents and mistakes at hospitals decreased from 312 in 2008 to 301 in 2009, reports NorthlandsNewsCenter.com.
  • Sen. Chuck Grassley sent a letter 31 hospitals nationwide asking about their experiences in implementing the $19 billion federal health information technology program launched last year. His office sent the letter to hospital systems that include Banner Health, Brigham & Women’s Hospital Case Western Reserve University Hospital Health System, Catholic Healthcare West, Cedars Sinai Children’s National Medical Center, Geisinger Medical Center, Hackensack Hospital, HCA TriStar, Intermountain Healthcare, Indiana University Hospital,  Jefferson Regional Medical Center, Kaiser Permanente System, Marshfield Clinic, Massachusetts General Hospital, Mayo Clinics, Memorial Hermann Healthcare System, Methodist Hospital of Indiana, North Shore-Long Island Jewish Health System, Palo Alto Medical Foundation, Rainbow Babies and Children’s Hospital, Saint Mary Mercy Hospital, Seattle Children’s Hospital, Stony Brook University Medical Center, Trinity Hospital System Tufts Medical Center, University of California San Francisco Medical Center, University of Pennsylvania Health System, University of Pittsburgh Medical Center, University of Virginia Medical Center, and Vanderbilt University Hospital. The full text of the letter is online at grassley.senate.gov.

Headlines: Meridia Warning, Pot Pie Recalls, New Safety Manual

Thursday, January 21st, 2010

WASHINGTON, D.C. – Patients who have a history of cardiovascular disease should not use the weight loss drug Meridia (sibutramine).

The U.S. Food and Drug Administration said today that there is an increased risk of heart attack and stroke in patients using sibutramine, which is marketed by Abbott as Meridia. The sibutramine drug label already includes warnings against the use of sibutramine in patients with cardiovascular disease. However, the new contraindication states that sibutramine is not to be used in patients with a history of heart issues. (more…)

Join RASMAS March 19 at the Maryland Patient Safety Conference

Thursday, January 21st, 2010

maryland_patient_safety_2BALTIMORE – Look for RASMAS staffer Kurt Acker at the 6th annual Maryland Patient Safety Conference.

The theme of the day is “Teamwork Makes the Dream Work …Hope, Trust, Partnership” with keynote speaker Susan E. Sheridan, co-founder and president of Consumers Advancing Patient Safety. The event runs from 8:15 a.m. to 4 p.m. It will be held March 19, 2010 at the Baltimore Convention Center.

Cooperating organizations in the conference include The Beacon Institute, LifeSpan’s Educational Affiliate; Health Facilities Association of Maryland; Maryland Association of Healthcare Executives; Maryland Healthcare Education Institute; Maryland Hospitals for a Healthy Environment; Maryland Nurses Association; Maryland Organization of Nurse Executives; Maryland Society for Healthcare Risk Management and Maryland Association for Healthcare Quality. See marylandpatientsafety.org