Wearable Device for Breast Self-Examination: Palpreast

Wearable Device for Breast Self-Examination: Palpreast

Product requirements

  • Functional requirements: the device should be wearable in contact with the skin, and it must not use electromagnetic radiation. It must be simple and safe. 

  • Usability requirements: The device has to be intuitive, to be used by all women, also without a medical background. It has to be wearable, for increasing the patient's comfort.

  • Safety requirements: The device should has not particular risks as it is intended for Self Examination device and not for diagnosis. Because it should mimic the breast palpation, the stress to be applied on the body will be low or moderate.

Risk Management for Palpreast according to ISO 14971:2007 “Application of Risk Management to medical devices”

  • Risk analysis

Tables 1 and 2 describe the hazards and the hazardous situations related to the use of Palpreast, respectively.

Table 1 - Palpreast hazards identification

Table 2 - Palpreast hazardous situations

According to Annex D of ISO 14971:2017, a semi-qualitative analysis was performed, using a 5x5 risk matrix where the levels of severity and probability are described in the Resources section (https://platform.ubora-biomedical.org/resources/6ca42f79-91f7-406f-b1d6-ceac9ca796aa)

Finally, Table 3 describes the Estimated risks for each hazardous situation related to Palpreast use and Table 4 shows a more the comprehensive risk matrix.

Table 3 - Estimated risk for Palpreast

Table 4 - Semi-quantitative 5x5 risk matrix for Palpreast

  • Evaluation Risk

According to ISO 14971, the “Evaluation of Risk” is defined as the “Process of comparing estimated risk against given risk criteria to determine acceptability of the risk”. For each identified hazardous situation, the manufacturer decides if risk reduction is required, on the basis of its acceptability criteria defined in the risk management plan. Table 5 shows the risk evaluation and risk acceptability for Palpreast.

Table 5 - Semi-qualitative 5x5 risk evaluation matrix. The green cells are related to acceptable risk, the red cells are relative to unacceptable risk

  • Risk control

According to ISO 14971, the “Risk control” is defined as the “Process in which decisions are made and measures implemented by which risks are reduced to, or maintained at, specified levels”. The risk control measures related to Palpreast use are described in Table 6.

Table 6 - Risk control measures for Palpreast use

All risks are considered acceptable.