By Jim Carr
The point of our job and the primary responsibilities of every imaging engineer is to make repairs and perform tests so that the scanners we service are producing scans the clinicians can use for diagnoses and are, at the same time, safe for the patients and the technologists who use them.
Mistakes we make or things we overlook while doing our job can lead to a patient or technician being hurt. Training you receive during your career should provide information on how a mistake that causes or misses the existence of a defect in the system can negatively impact uptime and patient safety. As usual, once you are trained it is your responsibility to heed and follow the instructions.
The original equipment manufacturers (OEMs) also have major responsibilities for patient and user safety. They are required to design the systems to reduce hazards, and to publish user and service documents that warn of potential dangers and explain how to mitigate the risks. They are also supposed to provide tools and documentation for testing the system so that we can make sure it is operating as designed. The compliance of OEMs with that FDA law varies a lot, depending on the modality and the OEM. We have to be able to assure proper system performance, so in those cases where we can’t get a password to access some tools or if the tools are not adequate for the job, we have to employ alternative testing methods and use third-party test equipment.
Many of us carry several pieces of test equipment that we use to make sure a system is working properly and safely. Phantoms, electrical safety analyzers (ESAs) and dosimeters are some of the more common ones.
Almost all scanners have some electrical safety concerns. In ultrasound, electrical leakage testing of the transducers often uncovers problems that present a cross-contamination risk to patients as well as the potential for shock.
One could even argue that an ESD field kit, used to minimize damage to components due to electrical static discharge, also contributes to patient safety by minimizing downtime. Some hospitals certainly think so. There have been MedWatch reports filed with the FDA regarding possible harm and at least one death because of an imaging system not being available to scan a critical patient because they were waiting on a password!
There are several aspects to the hazards presented by imaging systems, not the least of which is the risk of a misdiagnosis or a missed diagnosis if the scanner is not operating properly. The safety hazards of some scanners include mechanical assemblies that can break or fall off, such as injectors. Falling injectors are reported to FDA on a regular basis, and the OEM response in almost every case is “failure by user to follow the instructions.” If the OEM has made the information available, then the liability for failing to follow it is on the service engineers and the technologists.
Keeping the levels of ionizing radiation at known limits and within a defined beam are a major concern with CT scanners and other X-ray systems. Oscilloscopes and dosimeters have been part of the X-ray service tech’s tool bag for many years. Spiral CT scanners have been driving innovation in the detectors and measurement methods. The fancy, Bluetooth connected X-ray measurement systems available today do more than check for levels of radiation. They are used to check for proper operation of the scanner and formation of the X-ray beam, and can be a key tool for ongoing quality assurance.
As an imaging engineer, our reputation and livelihood depends on doing our best to assure the systems are safe and working properly. Despite FDA law that says they are supposed to do so, the OEM may not provide adequate instructions or may lock us out of diagnostic tools that are needed to properly maintain the system. The most specific and stringent requirements are for systems that emit radiation, such as CT scanners, which are covered in Part 1000 of 21 CFR. Part 1000 has some valuable benefits for those working on X-ray systems, primarily because in section 1020.40 (9) it requires the manufacturers to provide the AIAT information (for assembly, installation, adjustment, and testing) at a reasonable cost. Unfortunately for those of us working on MRIs, endoscopes, gamma cameras and ultrasound systems, there is not such specific verbiage. The FDA could do more to assure patient safety and reduce maintenance costs by forcing OEMs to follow the existing rules to provide tools and documentation for AIAT on all imaging modalities. Until that happens, we must continue to be innovative and resourceful in our profession to go beyond the sometimes limited resources we are provided to protect our patients and hospitals.
Jim Carr is Director of Service and International Operations for AUE. He may be contacted via email at JCarr@auetulsa.com.