BIOMED Safe

A Medical Equipment Management Plan

 

FS Medical Technology, an independent service organization is involved in all aspects of the medical equipment support industry.  Services are provided to medical facilities dependent upon increasingly complex equipment used for patient care, however without internal biomedical staffing to perform inspection and repair services.  The company provides inspection, preventative maintenance and service for these devices to ensure that they perform per manufacturer specifications and do not create hazards endangering the health and safety of either patients or staff.

 

FSMT was founded in 1992 as a full service biomedical engineering firm.  The company expanded into the medical gas field in 1998.  As a member of the Association for the Advancement of Medical Instrumentation (AAMI), all medical equipment reports are designed to meet TJC specifications.

 

Services are provided to a wide range of facilities, including: hospitals, clinics, laboratories, surgery centers, nursing homes and general industry.  The company also serves aviation emergency service providers with comprehensive airborne medical equipment services.Medical Equipment Management Plan

 

Biomedical equipment located within healthcare facilities must be safe for the patients served and employees and medical staff who use and manage these devices.  BioMed Safe, is a medical equipment management program (MEMP) designed to identify and manage these risks.  Equipment located within each  environment of care is identified by conducting and maintaining a proactive risk assessment.  FSMT’s MEMP is based upon applicable laws, regulations, and accreditation standards and is designed to manage the specific risks identified for medical equipment at the facility.

 

 

 

About Our Criteria and Standards

 

 

All FSMT programs are developed and administered in strict compliance with current laws and regulations using equipment and techniques approved by AAMI, NIOSH (National Institute of Occupational Safety and Health), OSHA (Occupational Safety and Health Administration) and NFPA (National Fire Protection Association).

 

Biomedical equipment repairs are performed using recognized procedures recommended by manufacturers.

 

Service equipment used by FSMT during calibration and performance checks are selected based on current industry recognized standards, and is maintained and calibrated in accordance with the respective manufacturer’s recommendations.  FSMT field technicians are trained in electronics, mechanics, pneumatics and optics to ensure up-to-date equipment knowledge.

 

 

 

 

Equipment Inventories

 

FSMT provides services to document all facility critical equipment.  These surveys document medical equipment with the potential to create a hazard to the health and safety of either patients or staff.  All identified equipment is provided with unique labeling and the listing is available in hardcopy or CD format.

 

Screening criteria are applied, as appropriate to loaner equipment, demonstration equipment, and equipment owned by physicians or other qualified individuals that is used as part of the care or treatment of a patient.

 

 

Equipment Acquisition

 

FSMT assists facilities in the formal process of acquiring equipment.  Services include identification of available options for consideration by the Capital Budget Committee.  Additionally, the company provides equipment replacement planning information to facilities prioritizing existing equipment items to be considered for replacement.  Factors included in this planning process include: age and physical condition of equipment, current utilization levels, clinical viewpoints regarding availability of parts in the next 2-5 years, reliability of equipment, and projected cost of maintaining equipment.

 

 

 

 

Incoming Inspections

 

TJC requires that all patient care equipment, whether owned, leased or rented must be tested for compliance with minimum safety and performance standards before being used for the first time for patient care.  FSMT provides these acceptance inspections and documents and records all findings.  Equipment having been withdrawn from use and placed in storage is also tested to these standards before being returned to service.

 

 

 

Maintenance Strategy -- Electrical Safety Inspection Program

 

Regulatory codes and accreditation standards, as well as prudent practice, make it mandatory to maintain a well-documented testing program to assure that the facility’s electrical distribution system and electrically powered equipment are free from fire and shock hazards.

 

FSMT provides a comprehensive hospital electrical safety program which checks the equipment and environment of all areas of the medical center (patient and non-patient locations) with properly documented test results maintained on file.

 

Safety standards utilized by the company are drawn from the AAMI Electrical Safety Manual, 2012 Edition.

 

 

Maintenance Strategy -- Periodic Inspections & Preventative Maintenance

 

FSMT conducts performance assurance and safety testing and manufacturer-specified scheduled maintenance.  The procedures and intervals followed for the scheduled maintenance are determined by manufacturer specifications and current nationally recognized safety standards as published by organizations such as ECRI and the American Society for Hospital Engineering.

 

The company’s computerized documentation system includes an exception report feature prompting an investigation of any incomplete scheduled maintenance items.  Service reports are included in the equipment master inspection record and are available to department managers and Safety Committee review.

 

 

 

Maintenance Strategy – Corrective Maintenance

 

When unscheduled service calls are required, FSMT dispatches a service technician to provide troubleshooting and, if possible, on site repair.  Those equipment items requiring bench repair at company facilities are transported to either the Sacramento service center.  On those occasions where manufacturer repair is required, FSMT coordinates repair and if necessary arranges for loaner equipment.  In emergency situations, initial response is within 4 hours and if on-site service is required, a technician is dispatched to the facility within 24 hours.  Technicians are required to document via a service report the nature of the problem and the nature of the repairs made.

 

 

 

Hazard Notification & Recalls

 

When an official recall notice from the equipment manufacturer is received by the facility, FSMT staff work to locate cited equipment and ensure that the specified corrective actions are completed.  In addition, FSMT staff monitors the technical literature (including ECRI Hazard Alerts and FDA Medical Device Reports) for information on reported or suspected hazards associated with specific medical equipment or devices.

 

 

 

In-service Training Programs

 

FSMT provides in-service training programs for facility staff regarding maintenance issues which lead to a better understanding of equipment function or service life extension.  Staff orientation programs are available to promote good electrical safety practices in special care areas.  These programs are often included in Continuing Education Programs to supplement manufacturer training.

 

 

 

Incident Investigations

 

Events within the facility in which someone is injured, or could have been injured, must be reported to the facility Risk Manager.  FSMT staff act as a resource to the facility and, on request, assist with investigating the circumstances of the incident.  Determination of whether or not the incident is reportable pursuant to the Safe Medical Devices Act of 1990 remains with the facility.   FSMT is well acquainted with TJC’s requirement to effectively use the Safety Committee to investigate and implement remedial action to resolve any hazardous conditions in the facility.

 

 

 

TJC Reports

 

FSMT technicians document each piece of equipment listed in the facility’s biomedical equipment inventory.  Service reports for each maintenance incident are included in these data.  Information is provided to detail any user related equipment problems or operator error trends.  “Cannot duplicate problems” are carefully catalogued.  All information is provided in a clear and concise formats which meet TJC standards.  Hardcopy or CD report formats are available.

 

 

 

 

 

 

Non-Medical Equipment

 

When equipment items do not qualify for inclusion in the medical equipment inventory, (electric beds, vacuum and oxygen regulators, x-ray view boxes, medical gas items, etc.)  FSMT provides mechanical, electrical and pneumatic services to address these needs.  Contact your FSMT sales representative regarding these additional programs.

 

 

 

 

 

 

 

 

 

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