Reliability Paper

Posted by Winnie Melda on November 19th, 2018

Software assurance of healthcare systems is significant to ensuring completeness, safety, and reliability of medical devices and software for the market. The transition from use of hardware to software controls in healthcare systems also necessitates for formalized software assurance processes. It gets attained by guaranteeing conformance to all requirements, regulations, standards, and procedures. A comprehensive quality assurance program plays a core role in minimizing the risks involved. The program should cover all the phases of the process including commissioning of a new system. Software assurance undertakes an oversight role that includes all the phases of software development, such as hardware-software integration activities. The assurance processes employed and the breadth and depth of their scope depend on various factors of which software criticality is the most significant. The methods comprise of the concepts of quality assurance, safety assessment and independent verification and validation analyzes. Despite the presence of software enforcement agencies such as NASA and Department of Defense, various challenges relating to documentation of the process, requirements, specifications and quality control concerns occur.

The US federal regulatory requirements for medical devices, software used in the devices, and standalone software systems allow for integration of any necessary improvements. Software gets used to develop new healthcare information technology solutions for high system criticality and also gets used in manufacturing certain medical devices and their validation before releasing to the market. There is, however, lack of sufficient oversight in decision support system logic embedded in Hospital Information Systems (HIS) software, despite the devastating consequences that would result from any errors in the system. The Food and Drug Administration (FDA) takes all medical devices through a classification process that determines the level of FDA regulation and approval necessary for each device. It then groups them into Class 1 (General Controls), Class II (Special Controls) and Class II (Premarket Approval). The Code of Federal Regulations (CFR) consists of the quality system requirements and current good manufacturing practices for healthcare devices. The oversight for healthcare-related software gets grouped into three that are, design controls, production and process controls and specifications. The Federal Register (FR) regulations comprise of the final decision for the current good manufacturing practices for the entire quality system regulations. The FDA has issued guidance regarding the general principles of software validation so as to reduce software failures. Other guidance documents by FDA include the content of Pre-Market Submissions for Software Contained in Medical Devices, Cybersecurity for Networked Medical Devices Containing Off-the-Shelf Software and Design Control Guidance for Medical Device Manufacturers.

The FDA’s current regulatory requirements and guidelines have a deficit in that they give space for interpretation and inconsistent software development and assurance measures to get used. Developing an overall scope for all healthcare-related software is necessary. Software verification and validation are the only part of the entire process that gets used to confirm compliance. It is necessary that all aspects of the software development lifecycle get monitored for compliance with applicable requirements, procedures, standards and regulations through incorporating rigorous quality assurance activities to enhance confidence in safety and reliability measures. Risk assessment at an early stage of the software development lifecycle should get conducted to ensure safe healthcare software. It is also critical to incorporate seasoned requirements analysts who guarantee the development of sound software assurance techniques. In the software implementation phase, a sound software development firm includes following well-set procedures and guidelines to undertake activities such as software coding practices, peer review processes, mentorship and code walkthroughs. In test planning and procedures a developer should include a requirement-based testing program and off-nominal testing beyond the stated boundaries and requirements. Technical, managerial and financial independence is vital in ensuring healthcare software safety.

The paper concludes by stating that ensuring software quality assurance, safety analysis, independent verification and validation and independent testing activities in healthcare systems results in improved safety, reliability and maintainability of these essential systems.

Discussion of the work

The work comprehensively discusses software assurance for medical devices. It explains the significance of ensuring software assurance for healthcare systems as well as describes the different impacts that may result due to lack of a comprehensive quality assurance program. The work describes the different activities undertaken in various software development processes so as to ensure safety and reliability of medical devices. The paper discusses the different standards, practices, procedures and regulations necessary for ensuring software assurance as well as the relevant enforcement agencies together with their shortcomings in undertaking their oversight role. The article also details the numerous improvements that can get incorporated in various processes, oversight practices, and software implementation procedures so as to ensure the production of an efficient and effective product.

Potential Improvements

The article is of good quality thus requires little improvements. A major improvement needed in the paper is the addition of more examples in various aspects. The examples may get sourced from real past experiences as well as different researchers. For instance, the risk management does not document the different risks that may get expected so as to improve the efficiency of the process.

Sherry Roberts is the author of this paper. A senior editor at MeldaResearch.Com in research paper writing help 24 hours if you need a similar paper you can place your order for essay writing services.