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.
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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.

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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.

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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.

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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
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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.

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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
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Implanted Devices

• Implanted devices that fail have to be
  reported.
• Surgically implanted devices that have been
  removed do not have to be reported.

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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

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 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)
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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.

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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.

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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.

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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/