Free White Paper - Guide to Developing Software Quality SOPs
Are you working to create a compliant quality system for your software development work, but unsure what topics to cover or what to incorporate in each procedure?
ShoeBar Associates has developed and refined these procedures many times, and has distilled that knowledge into a set of thoughts and questions to help you generate the SOPs you need.
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Standards and Guidance
November 5, 2010 - Pole-mounted Infusion Pumps Recalled
The manufacturer has initiated a nationwide recall of a specific model of pole-mount infusion pump after it discovered a problem with the pump door open alarm. If the pump door is not closed and latched properly, the door open alarm may not alert the user to the problem. If the door is not closed, the pump may not be engaged and gravity flow can occur, possibly resulting in an over-infusion of medication.
July 23, 2010 - Report: Software Defects in Cardiac Medical Devices Are Life-or-Death Issue
Software vulnerabilities in life-sustaining medical devices such as pacemakers and infusion pumps pose a growing threat to public health, warns a new report published by the Software Freedom Law Center.
July 20, 2010 - MHRA Issues Alert for EEG Recorder
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert for a specific model of EEG Recorder. The standard system has a left/right headbox configuration, but systems with software versions 5.3, 5.4 and 5.7 also have right/left headbox configurations. Operators could potentially confuse EEG outputs from the left and right sides of the brain when using the right/left configurations. The manufacturer has issued a field safety notice to remove the right/left protocols and overlays.
July 13, 2010 - Class I Medical Device Recall: Infusion Pump PC Units
Under certain wireless network conditions, a communication error can occur, which freezes the PC Unit screen. This error may result in a delay of therapy and inability to make programming changes to current infusions. If the communication error occurs during infusion, infusion continues on all channels, as originally programmed, but cannot be modified. When this error occurs, stopping the infusion to make any modification or programming changes causes the PC unit to shut down resulting in a delay or interruption in therapy. This could lead to serious injury and/or death.
July 12, 2010 - Alert Issued for Linear Accelerators
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert for a specific linear accelerator system. If a patient treated in a system with software version 6.X is then treated in another using version 7.X, the device could run the patient into the gantry, MHRA says. This is due to differences in the remote auto motion settings and rules between the software versions.
May 21, 2010 - AED manufacturer recalls battery packs
If the AED is used with an affected battery pack, the AED may falsely detect an error condition, cancel charge and not provide therapy.