Medical Equipment Management - Risk Management

Risk Management

This program helps the medical treatment facility avoid the likelihood of equipment-related risks, minimize liability of mishaps and incidents, and stay compliant with regulatory reporting requirements. The best practice is to use a rating system for every equipment type. For example, a risk-rating system might rate defibrillators as considered high risk, general-purpose infusion pumps as medium risk, electronic thermometers as low risk, and otoscopes as no significant risk. This system could be set up using Microsoft Excel or Access program for a manager's or technician's quick reference.

In addition, user error, equipment abuse, no problem/fault found occurrences must be tracked to assist risk management personnel in determining whether additional clinical staff training must be performed.

Risk management for IT networks incorporating medical devices will be covered by the standard ISO/IEC 80001. Its purpose is: "Recognizing that MEDICAL DEVICES are incorporated into IT-NETWORKS to achieve desirable benefits (for example, INTEROPERABILITY), this international standard defines the roles, responsibilities and activities that are necessary for RISK MANAGEMENT of IT-NETWORKS incorporating MEDICAL DEVICES to address the KEY PROPERTIES". It resorts some basic ideas of ISO 20000 in the context of medical applications, e.g. configuration, incident, problem, change and release management, and risk analysis, control and evaluation according to ISO 14971. IEC 80001 "applies to RESPONSIBLE ORGANIZATIONS, MEDICAL DEVICE manufacturers and other providers of information technologies for the purpose of comprehensive RISK MANAGEMENT".