Page 82 - Safety Risk Management for Medical Devices

Risk Management Process 61

An important, and sometimes missed aspect of medical device risk analysis is the
packaging. Packaging must protect the medical device in handling, transportation, and
storage. For sterile products, the packaging also has the duty of maintaining sterility of
the product. Packaging also has the role of protecting people, property, and the envi-
ronment from the device.
In addition to the Hazards that could directly harm patients, also consider
Hazards that could indirectly harm patients. An example of indirect Hazard is the
informational type. For instance, if a diagnostic device produces a false negative
result, it could mislead the clinician into not delivering the needed therapy to the
patient.

11.5 CLINICAL HAZARDS LIST

A CHL is a complete list of all the known and foreseeable Hazards that could poten-
tially arise from the use of the medical device. A claim of completeness is special and
noteworthy. How this claim can be made is by the mechanism with which the CHL
is created and kept up to date.
A good place to start for identifying the Hazards associated with the medical
device is Table E.1 of ISO 14971 [3,7]. Use this table as a thought stimulator. Likely
you will find many of the Hazards are irrelevant to your device, but on the other
hand it might bring to your attention, some Hazards that you could have overlooked.
Table B.2 of IEC 62366 [14] is another resource that could serve as a thought stimula-
tor for identification of Hazards due to use errors. Next, examine other sources.
Some suggestions are as follows:
• Literature search of comparable products
• Your internal historical data based on CAPAs and complaint handling database
• Adverse-events databases, e.g., MAUDE [16], EUDAMED [17]
• Input from subject matter experts

After you have compiled the list of Hazards, review it for duplications, and errone-
ous entries. It is common that people enter items in the CHL that are not Hazards. A
common mistake is to enter Causes, Hazardous Situations, or Harms in the list. Use
this test to distinguish true Hazards: “If someone was exposed to this item, could they
potentially be harmed?”
Examples of CHL entries that are not Hazards:
• Missing labeling
• Software
• Bleeding