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WorksheetsMDIP Reporting
Total questions: 20
Worksheet time: 22mins
A Medical Device _______ is an actual or suspected device deficiency; an unexpected quality issue that may affect performance or safety; a failure in its labelling, instructions for use, or design
Incident
A (a) is an event that has the potential for harm and is intercepted before reaching the patient.
Why should we report MIDPs? (select all that apply)
Learning
Quality improvement
Evidentiary
Mandated by Law
Reporting MDIPs is mandatory.
True
False
Completing an RLS - MDIP report automatically generates an MDIP report.
True
False
An event that reasonably could or does result in unintended injury or complications arising from health care management, with outcomes that may range from (but are not limited to) death or disability to dissatisfaction with health care management or require a change in patient care. Events that reach the patient.
Clinical Adverse Event
Close Call
Hazard
This label should be filled out for process(es):
A
B
C
This label should be filled out this label for process(es):
A
B
C
Where would you quarantine a consumable or reusable device, OR piece of equipment, following process A
Biomed
Kiron's Office
Wire shelf across from control desk
Select the correct reporting process to follow for this scenario. You notice your room is low on povidone-iodine prep. You go to soiled holding to get more, and note that almost all of the bottles appear to have prep solution leaking out of the lids.
Process A:
RLS MDIP Report
"CAE/HARM related" events
Process B:
RLS MDIP Report
"Close call" events
Process C:
MDIP Report
Hazards; Product complaints
Select the appropriate reporting process for the following scenario. A stapler misfires on a patient intraoperatively.
Process A
RLS MDIP
CAE/Harm Related events
Process B
RLS MDIP
Close Call Events
Process C
MDIP
Hazards/ Products complaints
Select the appropriate process for the following scenario. The scrub nurse is trying to load a screw on a new Xia screwdriver. The locking mechanism on the screwdriver will not work properly, so the screw is not securely loaded. The scrub nurse immediately informs the circulator, and hands the screwdriver off of the set up.
Process A:
RLS MDIP
CAEs/Harm Related Events
Process B:
RLS MDIP
Close Call Events
Process C:
MDIP
Hazard/Product Complaint
None of the above. The medical device was re-usable and follows a different reporting process
Select the appropriate process for the following scenario. A harmonic is opened and plugged into the generator as normal. The surgeon uses the harmonic once with no issues. When they attempt to use the harmonic again, an error message appears on generator stating that "device cannot be found". On visual inspection, there appears to be no damage to the harmonic hand piece.
Process A:
RLS MDIP
CAE/Harm Related Event
Process B:
RLS MDIP
Close Call Event
Process C:
MDIP
Hazard/Product compliant
None of the above. The event involves equipment which is reported through another channel.
From the previous scenario (Harmonic malfunction), which should be quarantined:
Harmonic hand piece only
Harmonic generator only
Harmonic generator and handpiece
Neither need to be quarantined
Select the most appropriate process for the following scenario. While preparing the theatre for a craniotomy, the nurse prepares the Doro skull clamp, and attaches the Doro skull clamp adaptor to the bed. The nurse completes all skull clamp adaptor safety checks and doesn't note any issues. Doro clamp is applied, patient is positioned, and surgery begins. Several minutes into the case the surgeon states that the doro is not secure and the patients positioning has been altered.
Process A:
RLS MDIP
CAE/Harm Related Event
Process B:
RLS MDIP
CLose Call Event
Process C
MDIP Report
Hazard/Product Complaint
None of the above. The medical devices is reprocessed and is therefore handled through another channel.
Select the most appropriate process for the following scenario. During a laparotomy, the surgeon notes that the Metzenbaum scissors being used are dull and require sharpening.
Process A
RLS MDIP
CAE/Harm Related Events
Process B
RLS MDIP
Close Call Events
Process C
MDIP
Product Complaints/Hazards
None of the above. This item repair/deficiency is handled through an other channel.
Select the most appropriate process for the following scenario. A brand-new piece of equipment has been brought into your department. While trying to familiarize yourself with the new equipment, you note that the two surgeon pedals, that perform vastly different functions are IDENTICAL (same size, shape, and colour), and using the wrong pedal could certainly cause patient harm.
Process A:
RLS MDIP
CAEs/Harm Related Events
Process B
RLS MDIP
Close Call Events
Process C
MDIP
Hazards/Products
None of the above are appropriate.
Select the most appropriate process for the following scenario. You are scrubbed on a robotic prostatectomy and the surgeon states that one of the endowrist instruments is not rotating as expected, making suturing very challenging. The instrument is noted to be on its 2nd (of ten) use.
Process A:
RLS MDIP
CAE/Harm Related Evetns
Process B:
RLS MDIP
Close Call
Process C:
MDIP
Hazard, Product complaint
None of the above are appropriate
Select the most appropriate process for the following scenario. You are scrubbed on a Left VATS for Left upper Lobectomy. The circulator dispenses a stapler and a staple load. You load the staple cartridge onto the stapler and note that the staples are raised, despite never having been fired. You immediately hand off the cartridge.
Process A:
RLS MDIP
CAEs/Harm Related Events
Process B:
RLS MDIP
Close Call Events
Process C:
MDIP
Hazards/Product Complaints
None of the above are appropriate.
Following this in-service, I feel:
pretty good about MDIP reporting!
Better about MDIP reporting than before, but still a bit unclear.
Still very confused about MDIP reporting.
I am more confused about MDIP reporting than before.
