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Abstract No. 376 EE: The Anatomy of a Medical Device Recall
Abstract No. 375 Perception of Radiation Exposure and Risk among Patients, Medical Students and Physicians at a Community Hospital. M.L. Ricketts,1 M.O. Baerlocher,2 M.R. Asch,3 A.B. Myers;3 1 University of Toronto School of Medicine, Toronto, ON, Canada; 2University of Toronto Residency Program, Toronto, ON, Canada; 3Lakeridge Health Corporation, Oshawa, ON, Canada PURPOSE: Medical imaging plays a greater role in patient care today than ever before due to its diagnostic and therapeutic capabilities and increasingly widespread accessibility. Most medical imaging tests utilize ionizing radiation and consequently increase the lifetime risk of cancer in patients. The knowledge of radiation dose associated with medical imaging tests and discretion are therefore required for those ordering and performing these tests in order to avoid unnecessary radiation exposure. The purpose of this study was to identify the background knowledge about radiation exposure and risk among inpatients and outpatients referred for radiology examinations and among medical students and referring physicians. MATERIALS AND METHODS: A multiple-choice survey was administered to patients, referring physicians, and medical students in order to determine background knowledge regarding radiation exposure and risk associated with commonly ordered medical imaging tests. RESULTS: One hundred and twenty-seven (127) patients, 32 referring physicians and 30 medical students completed the survey. The majority of patients (92%) were poorly informed of the radiation risks associated with tests they were scheduled to undergo and had false perceptions about the use of radiation as well as its associated risks. Physicians and medical students had misconceptions about the use of ionizing radiation in a number of radiological examinations; for example, 25% and 43% of physicians and medical students respectively were not aware that interventional procedures utilize ionizing radiation. Nine percent (9%) of referring physicians were unaware that CT scans were associated with ionizing radiation. CONCLUSION: There is a need for educating the public, medical trainees, and referring physicians about radiation exposure and associated risk so that 1) patients undergoing medical imaging tests are aware of the radiation they are receiving 2) physicians and trainees will be able to make informed decisions when ordering such tests to avoid unnecessary radiation, and 3) informed consent in terms of radiation dose associated with medical imaging will be promoted.
Other: Health Care Policy Abstract No. 376 EE The Anatomy of a Medical Device Recall. D.W. Hoenninger, C. Pohl, E. Zych, P.D. Edwards; Geisinger Medical Center, Danville, PA PURPOSE: Managing a medical product recall requires cooperation from a number of physician and nonphysician hospital personnel to quickly identify all affected patients and to implement an action plan with fail safe mechanisms. We present our response to a mediport recall which affected 68 patients (reportedly nationally the largest number in a single institution). MATERIALS AND METHODS: Upon notification of the mediport recall, we immediately proceeded jointly with the S138
departments of material and risk management to identify an initial list of possible patients affected by the recall by searching the radiology information system using applicable CPT codes over a time period expanded by one month before and after the ship date of the recalled device. A preliminary list was shared with oncology the day of notification. By day 2 the list was refined by eliminating prior removal, death, or non-recalled devices. The first patients were contacted and scheduled for explantation. Radiology, Oncology, Legal, and Risk management met on day 3 to draft a notification and our first port was explanted. By day 7 the final letter was sent via certified mail. Patients continued to be scheduled for removal. We had 68 patients with a recalled port. Of the 68 ports 8 ports were removed by surgery (1 pre-recall and 7 post-recall). A single port was removed at an outside hospital earlier. This left a subtotal of 59 remaining ports. 39 ports were removed by one interventionalist. All ports were photographed by Medical Photography and returned to the manufacturer. One port was lost following removal. 7 patients refused explantation. The 12 remaining patients died unrelated to the device by 2/16/2005. Half of the ports were explanted/exchanged over the 1st month. Most of the remaining ports were addressed over the next two months. Patients currently undergoing treatment had the port checked fluoroscopically before each use until removal. TEACHING POINTS: A meticulous multi-departmental approach to a recall is essential to streamline the steps required to identify and notify patients affected by such products. This requires duplicate independent searchable data bases, which should be part of any patient safety and device implant program.
Other: Practice Management Abstract No. 377 EE Free-Standing IR Practice Business Model in Interventional Radiology. J.L. Friese,1 C.-M. Fan,1 R.A. Baum,1 C.J. Jaramillo;2 1 Brigham & Women’s Hospital, Boston, MA; 2Harvard Business School, Boston, MA PURPOSE: To examine the benefits and risks of the freestanding IR practice and business model. MATERIALS AND METHODS: A thorough search to identify existing IR practices utilizing the free-standing model was performed using word of mouth and SIR personnel. Phone interviews and analysis performed. A framework for evaluating entrepreneurial ventures will be introduced. The importance of service model development will be highlighted and a potential model introduced. Evaluation of procedures amenable to the free-standing model will be proposed including the service model implications. A simplified financial model will highlight the financial opportunity. A thorough risk analysis is essential prior to any new venture; a basic risk categorization and ways to mitigate downside risk will be presented. TEACHING POINTS: 1) IR practice model is well suited to free-standing business model. 2) Free-standing model can be professionally and financially rewarding. 3) Excellent management team important for success. 4) Thorough risk assessment and understanding is crucial throughout implementation.
Other: Health Care Policy Abstract No. 376 EE The Anatomy of a Medical Device Recall. D.W. Hoenninger, C. Pohl, E. Zych, P.D. Edwards; Geisinger Medical Center, Danville, PA PURPOSE: Managing a medical product recall requires cooperation from a number of physician and nonphysician hospital personnel to quickly identify all affected patients and to implement an action plan with fail safe mechanisms. We present our response to a mediport recall which affected 68 patients (reportedly nationally the largest number in a single institution). MATERIALS AND METHODS: Upon notification of the mediport recall, we immediately proceeded jointly with the S138
departments of material and risk management to identify an initial list of possible patients affected by the recall by searching the radiology information system using applicable CPT codes over a time period expanded by one month before and after the ship date of the recalled device. A preliminary list was shared with oncology the day of notification. By day 2 the list was refined by eliminating prior removal, death, or non-recalled devices. The first patients were contacted and scheduled for explantation. Radiology, Oncology, Legal, and Risk management met on day 3 to draft a notification and our first port was explanted. By day 7 the final letter was sent via certified mail. Patients continued to be scheduled for removal. We had 68 patients with a recalled port. Of the 68 ports 8 ports were removed by surgery (1 pre-recall and 7 post-recall). A single port was removed at an outside hospital earlier. This left a subtotal of 59 remaining ports. 39 ports were removed by one interventionalist. All ports were photographed by Medical Photography and returned to the manufacturer. One port was lost following removal. 7 patients refused explantation. The 12 remaining patients died unrelated to the device by 2/16/2005. Half of the ports were explanted/exchanged over the 1st month. Most of the remaining ports were addressed over the next two months. Patients currently undergoing treatment had the port checked fluoroscopically before each use until removal. TEACHING POINTS: A meticulous multi-departmental approach to a recall is essential to streamline the steps required to identify and notify patients affected by such products. This requires duplicate independent searchable data bases, which should be part of any patient safety and device implant program.
Other: Practice Management Abstract No. 377 EE Free-Standing IR Practice Business Model in Interventional Radiology. J.L. Friese,1 C.-M. Fan,1 R.A. Baum,1 C.J. Jaramillo;2 1 Brigham & Women’s Hospital, Boston, MA; 2Harvard Business School, Boston, MA PURPOSE: To examine the benefits and risks of the freestanding IR practice and business model. MATERIALS AND METHODS: A thorough search to identify existing IR practices utilizing the free-standing model was performed using word of mouth and SIR personnel. Phone interviews and analysis performed. A framework for evaluating entrepreneurial ventures will be introduced. The importance of service model development will be highlighted and a potential model introduced. Evaluation of procedures amenable to the free-standing model will be proposed including the service model implications. A simplified financial model will highlight the financial opportunity. A thorough risk analysis is essential prior to any new venture; a basic risk categorization and ways to mitigate downside risk will be presented. TEACHING POINTS: 1) IR practice model is well suited to free-standing business model. 2) Free-standing model can be professionally and financially rewarding. 3) Excellent management team important for success. 4) Thorough risk assessment and understanding is crucial throughout implementation.