Boston Scientific reports no new unauthorized activity since Aug 25, while new cardiac device remote monitoring activations remain disrupted.
Boston Scientific is working toward the partial restoration of product shipping this week following a cybersecurity incident that caused a global network disruption to certain operating systems and business applications. The company identified the unauthorized activity on Aug 25 and continues to investigate the event with the assistance of CrowdStrike and other third-party experts.
As of Aug 30, Boston Scientific reported no indication of unauthorized activity in its environment since the initial discovery date. The investigation indicates that unauthorized activity was limited to specific on-premises systems, with no impact to cloud-based systems and applications.
Impact on Ordering and Shipping
The incident disrupted the company’s ability to manufacture products, process orders, and ship customer requests. While a timeline for full restoration is not yet established, the company is currently intaking orders electronically through electronic data interchange and local applications. These orders are being placed in a queue for fulfillment once systems return to full capacity.
“Our confidence in restoring these operations and access continues to increase, and we are expeditiously working towards partial restoration for the shipping of some products this week,” says Boston Scientific, in a release.
Device Safety and Monitoring Status
Boston Scientific says its investigation to date demonstrates no impact to implantable cardiac rhythm management (CRM) device function. It also doesn’t impact the device’s ability to transmit data, or healthcare professionals’ ability to access remote patient management data for CRM devices remotely monitored prior to the network disruption. Additionally, the company states there is no evidence of increased cybersecurity risks or difficulties transferring data from CRM remote monitoring systems to electronic medical records systems.
However, new remote monitoring activations are impacted by this disruption:
- For new cardiac device implants—CRM devices other than insertable cardiac monitors (ICM): New remote monitoring communicators cannot be activated, thus available device data will not be transmitted to remote patient management systems until the communicator can be activated. Programmer interrogations are not affected by this system disruption.
- For new ICM device implants: Newly implanted ICMs must be activated using the Boston Scientific Clinic Assistant app to enable the ICM to properly record episodes. New ICMs are unable to pair to the patient remote monitoring mobile phone, therefore available episode data recorded by the ICM will not be transmitted to the remote monitoring system until the ICM can be paired to the patient mobile app. Episodes will continue to be recorded by the ICM and can be transmitted to the remote monitoring system via an in-person interrogation with the Clinic Assistant app by selecting the “Interrogate” button.
Once systems are restored and pairing with home monitoring equipment occurs, the device will transmit recorded data to the remote monitoring system, according to updates from Boston Scientific. Timeline for full restoration is not yet known. Updates will be provided when these functions are restored.
