medical-device by veeru5656


									Medical Device Safety Lifecycle:
    Improving Patient Safety
   Medical Device Definition
 (Food, Drug &Cosmetic Act)
Used in the diagnosis, cure, mitigation,
treatment or prevention of disease or
Affects structure and function of the
Does not achieve intended use through
chemical reaction.
Is not metabolized.
Medical Device Safety Lifecycle

                                            Approval CE or SCM
       &/or Recall

                     Maintenance     Training
Introduction of New Devices
MCP 0076 New Medical Device
New Medical Device form shall be
completed prior to use of any new
medical device, including equipment for
patient care and diagnosis within the
Medical Center
When in doubt, fill out the form
         New Devices
Acceptance, safety inspection,
compatibility, education, procedures,
and appropriate purchasing documents
(including loan agreements).
To have CE checks, or not to have CE
checks? When in doubt, have CE
                     Device Failure Procedure
Equipment:                                Supplies:
  Remove the device from the                Before, during or after use
  patient.                                  Remove the device from the
  Take emergency measures to                patient.
  minimize the injury to the patient or     Take emergency measures to
  caregiver.                                minimize the injury to the patient or
  Take appropriate action to minimize       caregiver.
  damage to the equipment and the           Take appropriate action to minimize
  environment. Do not change any            damage to the supply and the
  equipment settings.
                                            Retrieve packaging of supplies if
  Keep all disposable products and          possible. If not, record catalog
  packaging. Retrieve packaging of          number, lot number and mfr info
  supplies if possible.                     and storeroom ID# as applicable.
  Impound all equipment so that it          Bag the supply and send to Barbara
  cannot be accidentally applied to         Strain or Nancy Stefanic, Supply
  another patient.                          Chain Logistics, Box 800690 or bring
                                            to room G525. Call 2-3857 or
  Tag Equipment with a Clinical             4-1812.
  Engineering Tag, describe problems.
  Call Clinical Engineering 4-2391 or
  page 1202 off-hours to retrieve
      Device Failure Reporting
  Problems with Medical Devices must be
  reported to:
 Supply Chain Logistics (Supplies) or CE
  (Equipment) (if no patient injury)
 Risk Management (if patient injury)
 Quality Improvement via Quality Report
     Fill out all equipment information on the QR
      including equipment ID, manufacturer name,
      catalog number, lot number and storeroom item #
      as applies.
What Types of Medical Device
Problems Should I Look for?
Software problems
Failure to work as intended/malfunction
Interactions with other devices
Use errors
Combinations of the above
    Why Reporting Medical Device
Problems Is Important In Our Hospital
 Prevent future problems and protect our patients, staff,
 families, and visitors
 Achieve performance improvement goals
 Assist Risk Management with claims or litigation
 Provide information to manufacturers and/or U.S. Food
 and Drug Administration
 Impact the public health for the general good of patients
 and health care providers
 Effect changes in policies and procedures
      When Do I Report?
When you think a device has or may
have caused or contributed to any of
the following outcomes (for a patient,
staff member or visitor):
  Serious injury
  Minor injury
  Close calls or other potential for harm
            Your Role
Identify actual and potential problems,
adverse events, close calls with medical
Report the problem or adverse event to
your supervisor, according to policy and
Make sure your report includes details
Remove the device, sequester all
affected items, save the packaging
      And Remember . . .
We can’t address issues we don’t
          know about.
             Please report.
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