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Medical Equipment and the Safe Medical Device Act SMDA

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Medical Equipment and the Safe Medical Device Act SMDA – PowerPoint PPT presentation

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Title: Medical Equipment and the Safe Medical Device Act SMDA


1
Medical Equipment and the Safe Medical Device
Act (SMDA)
  • Providence Health System - Oregon
  • Environment of Care

2
Purpose
  • The purpose of this course is to
  • Promote the safe use of medical equipment.
  • Reduce the risk of patient or staff injury.
  • Report serious injuries quickly and accurately.

3
Learning Objectives
  • Upon completion of this course, you will be able
    to
  • Determine which department to call for equipment
    repair and maintenance.
  • Identify 3 simple steps to prevent patient injury
    caused by medical equipment.
  • State purpose of green and yellow repair tags.
  • Appreciate the importance of user training.
  • Identify 5 steps to comply with the SMDA.

4
What is Medical Equipment?
  • The term Medical Equipment refers to
  • Devices used in the diagnosis, treatment or
    monitoring of patients
  • Any piece of medical equipment used by or on the
    patient

5
Who Services Equipment?
  • Clinical Engineering (Biomedical) and TSS
  • Imaging are your main service providers in the
    hospital. In the Satellites, Cooperative Health
    Resources is the provider.
  • They are part of Providences Technical
  • Support Services. Its part of Oregons
  • Medical Equipment Management Plan.
  • More details are found on their Intranet site
  • http//phsnet.phsor.org/tech_support/

6
The Plan
  • In the hospitals, Clinical Engineering is in
    charge of the overall equipment program. Three
    departments provide inspection, repair and
    preventive maintenance.
  • Physical Plant
  • Hospital beds
  • Medical gas alarms
  • Wheelchairs
  • Clinical Engineering
  • Monitors, Infusion Pumps
  • Outside Vendors
  • Catheters, tubing, forceps
  • Items under warranty
  • or special contracts

Physical Plant maintains hospital beds.
Cooperative Health Services is the medical
equipment service group for the Satellites.
7
Every Piece of Equipment Must Have a Tag
  • All Providence Medical Equipment must be
    inspected and
  • tagged prior to use on a patient.
  • Remember NO TAG NO USE
  • All patient care devices MUST have a
    Providence inspection tag.
  • All rental, loaned or demonstration equipment /
    accessories must be received and inspected by the
    appropriate medical equipment service group
    24-hours before its intended use.

8
Before you use a device on a patient...
  • Look for damage and test all equipment before its
    use on a
  • patient. Pay particular attention to the power
    cord.
  • If you suspect something is not
    functioning right or
  • or appears damaged
  • Remove the device from service.
  • Attach a Providence tag to the defective device.
  • Please give a detailed description of what is
    wrong.
  • Broke is too vague.
  • Put the date, your name and your unit on the tag
    in case we need to ask any questions about how
    the equipment failed.

9
Top Priority Medical Equipment Inspection Tags
  • Priority 1 Equipment GREEN TAG
  • Report overdue reinspection dates to
  • your service group.
  • Example Ventilators, defibrillators
  •  
  • Priority 2 Equipment YELLOW TAG
  • Report overdue reinspection dates to
  • your service group.
  • Example Patient monitoring,
  • electrosurgical units 

10
Medical Equipment Inspection Tags
  • Priority 3 Equipment BLUE TAG
  • Report to your service group when the piece is
    defective or broken. The equipment will be
    repaired / replaced at that time.
  • Example Intermittent suction, exercise
    equipment, etc.

11
Other Inspection Tags
  • Additional tags are
  • Inventory, Asset Management, Tracking Tags
  • Ignore the inspection date on this tag. It
    will be updated after this device is repaired.
  •  
  • Tags on Demo/Rental Equipment
  • Report overdue reinspection dates to your
    service group.

12
User Training
Clinicians must demonstrate how to operate
medical equipment safely before using it on a
patient. All medical equipment requires user
training.
  • Clinical engineering / TSS Imaging must file
    evidence of staff training for each medical
    device.
  • New equipment cannot be put in to service until
    all clinicians who will use the equipment have
    received training.
  • Training documentation is also required on all
    loaned devices and demonstration equipment.

13
Just Some TLC
  • Medical devices are very expensive. The large
    cost
  • reflects the amount of research time and limited
    distribution.
  • Please practice good Stewardship by doing the
    following
  • Take time to handle a device with care.
  • When transporting devices, to not stack them on a
    cart.
  • If a device is dropped, report it so it can be
    inspected before use.

Tender Loving Care
14
Safe Medical Device Act
  • The U.S. Food and Drug Administration (FDA) works
  • with manufacturers and health systems to prevent
    injury
  • and death from medical equipment. They all follow
    the
  • federal law outlined in the Safe Medical Device
    Act (SMDA).
  • Providence must investigate and report any
    device-related
  • death or serious injury.

15
Safe Medical Device Act
  • The Safe Medical Device Act
  • increases the amount of
  • information the FDA receives
  • about medical device problems.
  • With this information, the FDA
  • can take appropriate actions to
  • protect the public from
  • hazardous medical devices.

16
FDAs Definition of a Medical Device
A medical device is... An instrument, apparatus,
implement, machine, contrivance, implant, in
vitro reagent, or other similar article that is
intended for use in the diagnosis of disease or
other conditions, or in the cure, mitigation,
treatment or prevention of disease, or intended
to affect the structure or any function of the
body, and which does not achieve any of its
principal intended purposes through chemical
action within or on the body, and which is not
dependent upon being metabolized for the
achievement of any of its principal intended
purposes. Medical devices can be anything from
thermometers to artificial hearts to at-home
pregnancy test kits.   -Federal Food, Drug and
Cosmetic Act, Section 201
17
Implanted Devices
  • Implanted devices that fail have to be
    reported.
  • Surgically implanted devices that have been
    removed do not have to be reported.

18
SMDA Patient Care First
  • Employees play an
  • important role in the
  • SMDA reporting process.
  • Before you start the report
  • Stabilize the patient
  • Secure back-up or spare equipment
  • Locate and open an SMDA kit

19
 SMDA Kits
The SMDA Kits contain the following items
  • Instruction Sheet with reporting instructions
    phone numbers
  • 1 Large Isolation Bag
  • 1 Small Isolation Bag

Unusual Occurrence Report (UOR)
Defective Do Not Use Biohazard Labels 2
Plastic Ties (for bags)
20
SMDA Kits
  • SMDA kits should be available
  • in your department or from
  • Clinical Engineering.
  • These kits are for your
  • convenience.
  • If the items contained in the
  • kit are not necessary for
  • your event, simply
  • Fill out an Unusual Occurrence Report (UOR)
  • Follow the guidelines of the SMDA policy  

21
SMDA Starting the Process
  • Complete an Unusual Occurrence Report (UOR) to
    start the SMDA investigation process. Fill out
    all appropriate areas, especially
  • Condition of the patient
  • Identification of the device
  • Write the UOR number on
  • all tags, bags and other paperwork. The UOR
    number
  • links all documentation.

22
Reporting Defective Equipment
  • Write the devices Providence asset or control
    tag number on the UOR.
  • If you cannot find the tag, use the serial
    number.
  • Copy the serial number exactly as you see it.
    Include any letters or leading zeroes (e.g.
    00056678)
  • Remove the device from service. Attached a copy
    of the UOR. Do not dismantle or clean the device.
    This could affect the integrity of the
    investigation.
  • Save all disposables in a biohazard bag. Save any
    packaging that is available. Label all bags with
    the UOR number.

23
Quick Reporting Could Save Lives
  •  
  • Fill out and turn in the UOR promptly.
  • Providence has only ten days from discovery
    to file an SMDA report.

24
Not Sure if the Event Requires an SMDA?
  • Please call your Quality Manager or
  • Clinical Engineering Manager if you have
  • any doubts on what is an SMDA event.
  • When in doubt, fill it out (UOR)!
  • The SMDA committee will use the UOR to review the
    incident.
  • The SMDA committee meets within a couple days on
    urgent matters and at least quarterly.

25
For More Information
For more information, refer to your Department
Safety Flip Chart or talk with your Department
Safety Coordinator or Manager.
  • Check the Safety WebPages
  • on the Intranet for
  • Environment of Care (EOC) Manual
  • Contact information for
  • your Safety Managers
  • Use this Intranet link

http//phsnet.phsor.org/safety/
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