Decree 1 Annex 3 Guideline On Medical Device Adverse Event Monitoring Scope (draft)

Annex 3
Guideline on Medical Device Adverse Event Monitoring
Scope
(Draft)

1. Purpose
   In order to standardize the scope of medical device adverse event reports and improve
   the quality of the reports, this Guideline is formulated in accordance with the
   “Administrative Measures for Monitoring and Reassessing Medical Device Adverse
   Events” (Order No. 1 of the State Administration of Markets).
2. Scope of Reporting
   “Medical device adverse event” means a harmful event which occurs when a marketed
   medical device is in normal use and results in or may result in physical harm to human.
   Medical device adverse event reports should follow the principle of suspicious and
   immediate reporting. Medical device adverse events that causing or may causing serious
   injury or death should be reported. In the initial registration of innovative medical
   devices should report all medical device adverse events of the product. The adverse
   event report range should mainly be:
   2.1 Events Causing or May Causing Serious Injury or Death
   An event that causing or may causing death or serious injury during usage process due
   to the limitations of the clinical cases and confirmation methods of medical devices
   before they are listed, the risks caused by factors such as design, materials, technical
   requirements that do not meet the registration requirements, usage errors and defects
   in the instruction for use may not be fully recognized in the pre-market phase. Such as:
   2.1.1 The unreasonable design of knee joint replacement, resulting in knee joint damage
   due to fatigue, so that the patient has to undergo a secondary surgery. (design factor)
   2.1.2 The patient implanted polyethylene as acetabular material for hip joint
   replacement. Eight years after surgery, the polyethylene material is severely damaged,
   resulting in osteolysis and loosening of the prosthesis, and the patient have to undergo
   a second-surgery. (material factor)
   2.1.3 The material composition of a certain batch of ophthalmic perfluoropropane gas is
   inconsistent with the composition index at the time of registration due to the presence
   of toxic impurities in the production process, resulting in serious infection and blindness
   in the eyes of the patient. (not meeting technical requirements)
   2.1.4 In the examination table operation interface of the X-ray diagnostic system, the
   operation buttons of the two different functions is too close to each other, causing the
   operator to operate incorrectly, and the examination table does not stop at the expected
   position, causing the patient to fall from the examination table. (design flaws lead to
   usage errors)