Q&A – Potential patient safety issue connected to Sectra’s mammography solution

Previous versions of Sectra’s mammography system did not have sufficient safeguards to prevent a user from accidentally pressing the “Normal” button twice in quick succession in the so-called Arbitration workflow (where doctors talk about cases they feel need further discussion before taking a decision). If this happened in systems configured to automatically proceed to the next patient after a “Normal” classification, there was a risk that the next examination was also marked as normal—without a radiologist reviewing the mammography images.

This issue only affects healthcare providers in Denmark, Norway, and Sweden as customers in other markets do not do the reporting in Sectra’s system.

All affected healthcare providers have received a list of cases that may have been mistakenly marked as “Normal” and have reviewed these cases. In cases where an incorrect decision has been registered, these women have been contacted by their healthcare provider. This applies both if they needed to be called for a new examination or if they are already in treatment and have been informed that their diagnosis may have been delayed due to the previous mistake.

If you have not receive a notification at this point, you can feel confident that your screening result was correctly assessed. All potentially affected healthcare providers have completed the review process.

Yes, absolutely.

All healthcare providers using Sectra’s system have now upgraded to a version that includes additional safety mechanisms to prevent this issue from happening again.

Mammography screening is extremely important for early detection of breast cancer, and we strongly encourage all women to attend their screenings when invited.

The mammography screening programs in Denmark, Norway, and Sweden are among the most well-established and high-quality programs in in the world.

Sectra takes this matter very seriously and is working closely with healthcare providers and the Swedish Medical Products Agency (Läkemedelsverket) to investigate and follow up on the issue.
As of today:

• All Sectra mammography customers have implemented a fix—either by upgrading to a version with additional safety measures or by adjusting system configurations to eliminate the risk.
• Healthcare providers have reviewed potentially affected cases to ensure they were properly assessed and contacted women where needed.