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APPENDIX C
STATCLAVE Cybersecurity Statement
A network disruption or cybersecurity incident will not prevent this device from performing its primary
function of completing a sterilization cycle. Additionally, a cybersecurity incident affecting the device
cannot result in direct patient harm since the device does not come into contact with a patient. While
the unit records, stores and sends (if connected to a network) information about a cycle, no patient
data is stored on the unit.
The unit’s functionality and design observe a number of additional cybersecurity risk mitigation
measures:
›
Prevents unauthorized access to safety-critical settings.
›
Ensures trusted content by maintaining code, data and execution integrity.
›
Recovers capabilities or services that were impaired due to the cybersecurity incident.
›
Authentication methods and controls are used for each part of the communicating assets such
as web sites, servers, interoperable systems and cloud storage.
Addressing STATCLAVE Cybersecurity Vulnerabilities
STATCLAVE
Item
CBOM Item
National Vulnerability Database
Reference
Control / Rationale
Microcontroller
logic board
Vybrid VF6xx
CVE-2017-7936
ERR010872 – Secure Boot
Vulnerability when using the
Serial Downloader (CVE-2017-
7936)
-SDP protocol redirected to UART 3 and
pins are not available (not connected)
-SDP protocol available to USB0.
Connection not available outside of the
PCB. Physical access to logic board
required in order access USB0 OTG port
(physical locks in place).
Microcontroller
logic board
Vybrid VF6xx
CVE-2017-7932
ERR010873 – Secure
Boot Vulnerability when
Authenticating a Certificate
(CVE-2017-7932)
-SDP protocol redirected to UART 3 and
pins are not available (not connected)
-SDP protocol available to USB0.
Connection not available outside of the
PCB. Physical access to logic board
required in order access USB0 OTG port
(physical locks in place)
Operating
system
MQX 4.2
ICSA-17-285-04A Classic
Buffer Overflow, Out-of-Bounds
Read
Patched DHCP client to address the buffer
overflow
SSL stack
WolfSSL 3.14
CVE-2018-12436 (ROHNP)
Does not apply as attacker is required to
run code on the same host (embedded
platform) where the Wolfssl library is
running. Embedded platform does not
allow running of unauthorized code.
WiFi module
GS2011MIE
n/a
n/a
