Public Health Effectiveness of the FDA 510(k) Clearance Process Measuring Postmarket Performance and Other Select Topics: Workshop Report (2011) / Chapter Skim
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5 Other Select Topics
5 Other Select Topics
Pages 47-60
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From page 47... ...
Fu presented an overview of a report that he was commissioned to prepare for the committee to summarize the role of trustworthy software in the safety and effectiveness of medical devices.1 "Software trustworthiness" is a system property that measures how well a software system meets operating requirements allowing stakeholders (such as patients, health-care professionals, and service providers) to trust the operation of the system.
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From page 48... ...
Electronic health records, if designed correctly, could reduce errors substantially, especially errors of patient misidentification. But electronic health records will need to have very strong integrity guarantees and strong security and privacy, and there is an issue of interoperability among hospitals and systems.
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From page 49... ...
A message appeared on the device screen indicating a "buffer overflow," and the pump shut down. In simple terms, a buffer overflow occurs when the buffer has too little memory space to hold the information that the program is attempting to place in it.
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From page 50... ...
Better analysis of human factors and how they interact with software could help to prevent injury and death, Fu said. Software Maintenance Software users are familiar with the dialogue boxes that appear on a computer screen and advise that a software update is available and should be downloaded and installed.
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From page 51... ...
Discussions on technology support-group Web sites suggest that end users are often helpless when it comes to dealing with these systems. Fu cited an online forum discussion in which a user was seeking information on how to downgrade the Windows operating system to a prior version (for example, from version SP3 to SP2)
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From page 52... ...
Fu noted that in May 2010, Roger Baker, chief information officer for the US Department of Veterans Affairs (VA) , testified before a House of Representatives subcommittee that over 122 medical devices in the VA network had been compromised by malware during the preceding 14 months.
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From page 53... ...
They included the idea that device manufacturers need to be incentivized to adopt modern software-engineering and systems-engineering technologies -- from static analysis to programming languages that are more easily able to integrate with requirement specifications. Better analysis of human factors that come into play in the use of device software could help to prevent injury and death.
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From page 54... ...
Background and Objectives Class III devices are defined by FDA as devices that support or sustain human life, that are of substantial importance in preventing impairment of human health, or that present an unreasonable risk of illness or injury. The PMA process is the most stringent type of device-marketing application required by FDA and is required for most class III devices.
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From page 55... ...
. GAO found that 78% of the 217 original and 85% of the 784 supplemental PMA submissions for class III devices were approved through the PMA process .
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From page 56... ...
One example cited by Redberg was the NaviStar Thermocool ablation catheter, which has a target stated in the SSED of 50% chronic success but was approved on the basis of achieving 47%. Redberg noted several limitations of the study.
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From page 57... ...
With regard to the additional confidential data that may be part of a PMA application, Redberg said that she was able to request access to the confidential files for a number of the PMAs that were part of the study, and her review of the additional data did not change the overall findings of the review of the SSED data described in the paper. Opportunities for Improvement On the basis of her study results, Redberg offered several recommendations for improving the FDA PMA process for high-risk devices: · equire at least one randomized and blinded study for each device.
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From page 58... ...
Fischell, founder and chief technology officer of Neuralieve Inc., described his company's recent experience in working to bring a product to market through the 510(k) clearance process as an example of industry concerns with a perceived lack of transparency and consistency in decision making.
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From page 59... ...
2009. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices.
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