Identification Of Qualitative And Quantitative Characteristics Related To Medical Devices

For the particular device or accessory being considered, list all those characteristics that can affect its safety and, where appropriate, list their defined limits.

a) What is the intended use and how is the device to be used?

Factors that should be considered include the intended user, the required skill and training of the user, in which environment it is to be used, by whom it will be installed and whether the patient can influence the use of the device. Special attention should be paid to users with special needs like handicapped persons, the elderly and children. Their special needs might include assistance by another person to enable the use of a device.

b) Is the device intended to contact the patient or other persons?

Factors that should be considered include intended contact, surface contact, invasive contact implantation and, respectively, the period and frequency of contact.

c) What materials and/or components are incorporated in the device or are used?

Factors that should be considered include whether the characteristics relevant to safety are known.

d) Is energy delivered to and/or extracted from the patient?

Factors that should be considered include the type of energy transferred and its control, quality, quantity and time function.

e) Are substances delivered to and/or extracted from the patient?

Factors that should be considered include whether the substance is delivered or extracted, whether it is a single substance or range of substances, the maximum and minimum transfer rates and control thereof

f) Are biological materials processed by the device for subsequent re‑use?

Factors that should be considered include the type of process and substance(s) processed, e.g. auto‑transfusion, dialyzers

g) Is the device supplied sterile or intended to be sterilized by the user or are other microbiological controls applicable?

Factors that should be considered include whether the device is intended for single use or to be re‑usable, any packaging, the shelf life and arty limitation on the number of re‑use cycles or type of sterilization process to be used.

h) Is the device intended to modify the patient environment?

Factors that should be considered include temperature, humidity, atmospheric gas composition and pressure.

i) Are measurements made?

Factors that should be considered include the variables measured and the accuracy and the precision thereof.

j) Is the device interpretative?

Factors that should be considered include whether conclusions are presented by the device from input or acquired data, the algorithms used and confidence limits.

k) Is the device intended to control or to interact with other devices or drugs?

Factors that should be considered include identifying other devices and drugs which can be involved and the potential problems associated with such interactions.

l) Are there unwanted outputs of energy or substances?

Energy‑related factors that should be considered include noise and vibration, heat, radiation (including ionizing, non‑ionizing and ultraviolet / visible / infrared radiation), contact temperatures, leakage currents and electrical and/or magnetic fields.

Substance‑related factors that should be considered include discharge of chemicals, waste products and body fluids.

m) Is the device susceptible to environmental influences?

Factors that should be considered include the operational, transport and storage environment including spillage, and power and cooling supplies.

n) Are there essential consumables or accessories associated with the device?

Factors that should be considered include specifications for such consumables or accessories and any restrictions placed upon users in their selection of these.

o) Is maintenance and/or calibration necessary?

Factors that should be considered include whether maintenance and/or calibration are to be carried out by the operator or user or by a specialist.

p) Does the device contain software?

Factors that should be considered include whether software is intended to be installed, modified or exchanged by the user and/or operator.

q) Does the device have a restricted shelf life?

Factors that should be considered include labelling or indicators and the disposal of such devices.

r) Possible delayed a and / or long term use effects?

Factors that should be considered include ergonomic and cumulative effects.

s) To what mechanical forces will the device be subjected?

Factors that should be considered include whether the forces to which the device will be subjected are under the control of the user or controlled by interaction with other persons

t) What determines the lifetime of the device?

Factors that should be considered include ageing.

u) Is the device intended for single use or re‑use?