Risk managers are, by nature, a skeptical group, assuming the worst. That is, if something can go wrong from a design, systems, staffing, training, or misuse perspective, it will. There are many activities in which clinical engineers participate that can help the risk manager sleep at night, if these activities are managed and communicated to the risk manager consistently. Clinical engineering risk issues that have come to the forefront of health care risk managers in recent years include the following:
● Device recalls ● Devicetracking requirements ● Device-incident investigations using root cause analysis ● Device procurement using Failure Modes and Effects Analysis (FMEA) ● Clinical department technology risks, such as:
1. Critical alarms 2. Neonatology 3. Lasers 4. Hemodialysis 5. Anesthesia
● Reuse of devices ● Alternate parts and supplies ● EMI interference ● Disposal of used equipment ● In-house repair and device modifications
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● Off-label, off-shelf, and unapproved uses of devices ● Patient- or physician-owned equipment ● Borrowing and lending equipment
Other areas where clinical engineers can contribute to risk management include lasers and anesthesia and other gases. The clinical engineer can make significant contributions to the selection, safety procedures in use, and continuing safe operation of surgical and ophthalmologic lasers. While some lasers may be handled by laser technicians or the manufacturer, it is important for a trained professional within the organization to have a close working knowledge of the devices in case an adverse event may be related to them. In addition, problems in administrating the proper gas and in eliminating known waste gases have resulted in significant risk and losses to health care organizations. In some organizations, the responsibility for such issues rests with facilities engineering. In other organizations, partial or complete responsibility for medical gases and their waste elimination rests with the clinical engineer. Initial and routine testing of medical gases and the effectiveness of their elimination methods are recommended. Testing gas elimination methods following any work performed on the systems can help control risk. If clinical engineers acknowledge these significant risks and communicate with the risk manager to identify the policies and procedures for minimizing risk in these areas, the risk manager will sleep better at night and patients will be safer. Risk management is every employee’s responsibility. Each employee performs risk management tasks every day, although they may not often be aware of this important function, nor may they given credit for their contributions to patient safety. From a clinical engineering perspective, identification of potential or actual problems with equipment, adherence to regulations, and reporting and investigation of incidents are all risk management functions