Clinical Alarm Systems - NPSG Goal # 6 - A Learning Module Clinical Alarm Systems - NPSG Goal # 6 -

Purpose and Objective: To ensure there is a process for safe medical device alarm management and response in high risk areas. Objective: After reviewing the module, the staff will be able to identify medical devices that are high priority clinical risk alarms and how to respond appropriately and timely to these alarms.

Definition of Terms: Medical Device A piece of equipment designated by the Food and Drug Administration (FDA) as a medical device. High Risk Clinical Alarms Condition A medical condition that is considered life threatening to a patient if actions are not taken. Critical Alarms Alarms on medical equipment are designed to alert staff to the presence of a life-threatening condition.

Definition of Terms: Non-Critical Alarms Alarms on medical equipment are designed to alert staff to the presence of a non-life threatening condition. Low Risk: Non-life threatening need attention and may cause a delay in care. Moderate Risk: Potential for harm if the issue causing the alarm is not acted upon.

Definition of Terms: Critical Areas - continuation High risk areas at CHSB are identified below: Cardiac Catheterization Lab Peds Sub Acute Emergency Department (ED) Intensive Critical Care Unit (ICCU) Interventional Radiology Labor and Delivery Medical/Surgical Units Medical/Surgical Units Neonatal Intensive Care Unit (NICU) Neurocare Unit (NCU) Pediatrics Perioperative Services Telemetry

Background: National Patient Safety Goal # 6 - Reduce the harm associated with clinical alarm system - Clinical alarm systems are intended to alert caregivers of potential patient problems, but if they are not properly managed, they can compromise patient safety. Alarms are meant to call the attention of caregivers to patient or device conditions that deviate from “normal status.” They are generally considered to be a key tool in improving the safety of patients The purpose of ALARM SYSTEM is related to “communication information that requires a response or awareness by the operator.”

Background: When caregivers rely on alarms, it becomes essential that the alarms perform to their expectations. When alarms do not perform well, patients may not receive the care they need, with potentially serious adverse consequences. This NPSG focuses on managing clinical alarm systems that have the most direct relationship to patient safety. It is the policy of CHSB to ensure safe operation of all medical devices and the appropriate and timely response to all clinical alarms particularly critical alarms.

Staff Responsibility: It is the responsibility of all CHSB staff to ensure the safe operation of all medical devices and to ensure the appropriate and timely response to all clinical alarms particularly critical alarms.

Implications of Clinical Alarms on Patient Care Cases Related to Alarms: A family in Boston recently accepted an $850, 000.00 settlement in a case where alarms were defeated, which underscores the tragedy and costs associated with technology hazard. Recent survey by Healthcare Technology Foundation (2011) one in five respondent hospitals identified an avoidable adverse event due to alarms in the past two years. Review of the FDA Maude database for 2011 for the class of arrhythmia-detecting monitors indicated 550 reported alarm hazards, resulting in 35 deaths.

CHSB Policy and Procedure on Clinical Alarms Critical alarms on clinical monitoring and intervention systems will be maintained in the “on” position and will be sufficiently audible to the staff. Non-critical alarm parameters will be set either to the default settings established by the manufacturer or as clinically warranted based on the patient’s condition. Operational functionality of medical device alarms will be checked in according to the manufacturer instructions as part of the equipment’s biomedical preventative maintenance and repair program.

CHSB Policy and Procedure on Clinical Alarms Staff training on proper operation of medical devices will include the identification and verification of critical alarms and settings. A cross-disciplinary team that includes representation from clinicians, clinical engineering, information technology, and risk management will meet as needed.

High Priority Clinical Risk Alarms: Higher Priority Clinical Risk Alarms have been identified as follows: BiPap Cardiac Monitor Fetal Monitors Hugs IV Pumps, syringe pumps, PCA Pulse Oximetry Ventilators

Documentation

Med/Surg and Telemetry Documentation Document all alarms in IView/I&O/Graphs Under Med Surg Flowsheet Under Section ADL’s

Adding Comments with Your Documentation Adding comments with your documentation can be done by RIGHT Clicking on the section to access the other screen Document your comments on the screen provided

NICU Documentation Document all alarms in IView/I&O/Graphs Under NICU Assessment PCM Under Section Alarm Safety & Equipment

Appendix: Staff will be provided with a booklet of the Prioritized High Clinical Risk Alarms

Sample of Booklet:

Sample of Booklet:

Sample of Booklet:

Thank You