Biomedicina - Inducción Corporativa - Promedan S.A.

Introduction to Biomedical Process

Importance of Biomedical Management

• The primary goal is to manage the entire lifecycle of biomedical equipment, including planning, selection, purchase, installation, training, clinical use, maintenance, and final disposal while adhering to current regulations.

Definition of Biomedical Equipment

• Biomedical equipment encompasses operational and functional devices that include electrical, electronic, hydraulic, hybrid systems and mechanical components requiring a power source. This includes all software programs necessary for their proper functioning.

Activities Ensuring Patient Safety

• A series of activities are conducted within the biomedical process to ensure patient safety and extend the lifespan of equipment. This begins with preventive maintenance according to a pre-established schedule based on manufacturer recommendations.

Maintenance Types in Biomedicine

Preventive vs. Corrective Maintenance

• Preventive maintenance aims to prolong device life and prevent malfunctions through scheduled tasks as specified by manufacturers.

• Corrective maintenance restores integrity or functionality after a failure; it is synonymous with repair processes aimed at addressing issues post-failure.

Metrology in Biomedical Processes

Validation and Calibration

• Metrology involves validation (comparing instruments directly for accuracy verification), primarily applied to autoclaves across services.

• Calibration compares measurements between two devices (standard vs. test instrument), executed only on weighing or measuring equipment.

Reporting Mechanisms in Biomedicine

Valid Reporting Channels

• While various communication tools exist (WhatsApp, calls), valid reports must be submitted via the institution's designated platform for effective processing.

Medicinal Gases in Healthcare

Importance of Medicinal Gases

• Medicinal gases like oxygen and nitrogen are crucial for patient care; they support respiratory functions and are essential during diagnostics and surgical procedures.

Acquisition Process for New Technology

Steps in Equipment Acquisition

• New technology acquisition occurs under specific circumstances such as service expansion or equipment renewal; it involves procurement processes that assess institutional needs.

Role of Staff in Equipment Requests

• The biomedical process collaborates with healthcare staff to identify needs; requests typically come from department heads who evaluate new equipment requirements based on operational demands.

Training for Effective Equipment Use

Significance of Staff Training

• Training is vital for ensuring proper usage of medical devices; it minimizes risks associated with adverse events during patient interactions.

Conditions Triggering Training Sessions

• Training sessions occur when there’s software updates or new equipment acquisitions; they also respond to personnel changes or new service openings involving biotechnology.

Technovigilance and Radiological Protection in Biomedical Processes

Overview of Technovigilance

• The technovigilance program is integral to biomedical processes, focusing on post-market surveillance of medical devices to identify, collect, manage, and disseminate adverse events.

Patient Safety Platform

• A patient safety platform exists in the institution that includes a notification module for reporting incidents related to medical device usage.

Radiological Protection Program

• The institution has a radiological protection program aimed at ensuring proper use of ionizing radiation-generating equipment through quality control measures.

Quality Control Measures

• Quality control studies are conducted biennially by an external provider to verify equipment functionality and measurement parameters for imaging.

Preventive Maintenance

• Preventive maintenance occurs every six months to extend the lifespan of equipment and ensure it operates within appropriate standards.

Training and Personal Protective Equipment (PPE)

• Workers exposed occupationally must undergo training in radiological protection, which includes knowledge about personal protective equipment like lead vests and thyroid protectors.

PPE Guidelines

• Specific PPE requirements vary by radiation category; Category 1 requires only vests while Category 2 mandates additional protective gear.

Regulatory Framework for Medical Devices

• Various regulations govern medical devices, including:

• Law 100 of 1993 establishing the integral social security system.

• Decree 4725 of 2005 regulating sanitary registration and monitoring.

• Resolution 3100 of 2019 for habilitation systems.

Additional Regulations

• Other significant resolutions include those governing quality control for ionizing radiation-generating equipment and the provision of radiological protection services.