MDIP Reporting

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

• Problem
• Incident

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

Answer explanation

BUT, the reverse is NOT TRUE. completing a stand-alone MDIP report does NOT generate an RLS report. Remember: MDIP reports are MANDATORY per law, whereas staff have the responsibility to VOLUNTARILY report in the RLS.

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

Answer explanation

Devices or equipment involved in CAE's/Harm Related Events, must be quarantined "under lock and key". In Process B and C, devices (consumable and reusable) are quarantined on the wire shelf across from the control desk. In Process B and C, equipment is quarantined in Biomed.

If a consumable/reusable instrument and equipment were involved in the same incident, ideally, they should be kept together. Ensure both device and equipment are labeled.

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