The nursery rhyme involving Humpty Dumpty is a child's first lesson in safety. What would keep Humpty Dumpty safe as he is sitting on the wall? A warning or a railing?
The dependence in medicine on technology to deliver services is continuously growing. The number of microprocessor-based diagnostic, therapeutic, and patient monitoring devices used in the clinical environment is ever-increasing. As device malfunctions are noted and investigated by clinical engineers, increases in the number of device failures attributable to interference generated by equipment producing electromagnetic energy in the radio frequency (RF) spectrum have been documented. Warnings are issued by manufacturers and agencies that monitor the safe uses of biomedical instrumentation. For the most part, manufacturers and agencies depend on reports from institutions using the affected products. In spite of the risks to devices, and therefore to patients, many events attributable to electromagnetic interference (EMI) go unreported. The clinical engineer, educated in the causes and effects of EMI, is capable of implementing a risk-reduction program that includes training for users, environmental assessment, identification of possible sources, and mitigation of the risks (wherever possible) resulting from these conditions.
Years of research have shown that all clinical facilities, whether in urban, suburban, or rural areas, are subject in varying degree to the effects of EMI. The quantity of documented incidents of EMI affecting clinical devices may represent but the tip of the iceberg. Experiences during investigations of EMI at Texas Children's Hospital, St. Luke's Episcopal Hospital, and various other facilities indicate statistically that many events demonstrably attributable to EMI go unreported. Under-reporting appears to be caused by lack of training and knowledge in the identification of EMI-related device failures, lack of reporting structure, and concern with a potential admission of implied risk that could result in subsequent litigation.
Patients as well as the facility in which they are cared for are dependent on the reliable operation of clinical devices. Reliable operation is complicated by an environment made ever more hostile by increasingly complex impinging electromagnetic fields emanating from a variety of sources. This has resulted in the increase of momentary, partial (visible and invisible), and complete failure of clinical devices due to EM!. Failure of active clinical devices increases risk to patients and reduces cost-effectiveness, because use of the device is restricted until the cause of failure can be diagnosed and corrected. Therefore, a comprehensive program for managing EMI through monitoring, education, and control has proven to be of benefit in terms of both risk avoidance and cost containment.
In order to be successful, a program for managing the risks associated with EMI must have the following elements:
Unlike most applications of maintenance of electronic and electromechanical devices, the detection and mitigation of the effects of EMI have been likened to "ghost hunting." Conventional troubleshooting techniques provide limited results when we are looking for the cause of EMI.
To be successful in the detection of EMI and the mitigation of its effects, the clinical engineer must understand and fully appreciate the following guidelines:
Responses by institutions have been varied and range from aggressive, adequately funded and staffed EMI reduction programs to apathy based on disbelief. The most common complaint encountered is the lack of personnel with experience in the dynamics of RF and related EMI. Following closely is lack of funding to meet the equipment requirements for successful "ghost hunting," limiting mitigation options. Last is a diminishing number of institutions that do not yet believe that EMI poses a threat to diagnostic and therapeutic clinical devices and, consequentially, risk to patients utilizing those devices. It is hoped that further education of clinical, technical, and administrative staff will further reduce the number of such institutions. Therefore, clinical engineers are faced with the challenge and responsibility to guide these institutions toward safer patient care environments.
Dr. Yadin David, has over 25 years experience in Managing Medical Technologies from Pre-Purchasing Evaluation, Installation, Training, to Servicing and Incidents Investigation. He is expert familiar with a wide variety of medical devices and accessories including infusion pump, laser, electrosurgery unit, monitors, X-ray, defibrillators and catheters. Dr. David is also an expert in Electromagnetic interferences (EMI) with medical devices and in Telemedicine and TeleHealth systems.
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By: John Hoschette
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