Insulin Pump Software Certification

Chen, Yihai; Lawford, Mark; Wang, Hao; Wassyng, Alan

doi:10.1007/978-3-642-53956-5_7

Cited by 23 publications

(11 citation statements)

References 19 publications

(20 reference statements)

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“…Insulin pumps represent software-intensive medical devices. 75 Most complex pumps include software that presents past basal and bolus doses as well as additional information that may assist patients and clinicians in diabetes management. 76 Software can be used for dosage control, providing display output or coordinating functions of various components within the pump as well.…”

Section: Software For Insulin Pumpsmentioning

confidence: 99%

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Insulin Pump Therapy for Patients With Type 2 Diabetes Mellitus: Evidence, Current Barriers, and New Technologies

Freckmann

Buck

Waldenmaier

et al. 2020

J Diabetes Sci Technol

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An increasing number of patients with type 2 diabetes mellitus (T2DM) use insulin pumps. The first insulin pumps especially designed for patients with T2DM have recently become available. However, national guidelines do not primarily recommend the use of continuous subcutaneous insulin infusion (CSII) for this patient group. The effectiveness of CSII in T2DM has not yet been convincingly demonstrated, despite some positive evidence. An overview and an assessment of various studies to date will be given. T2DM is a heterogeneous disease with a substantial phenotypic variability; therefore, it is difficult to provide general conclusions about the effectiveness of CSII in T2DM therapy. The pump types, characteristics, and associated barriers may play a relevant role for therapy outcome. Most advanced functions like various bolus dosages offered by conventional insulin pumps are not needed for T2DM treatment and complicate the device handling for this subject group. Additionally, new technologies like increased connectivity, advanced software features, and interoperability are currently becoming available representing further barriers. The implementation of this technological progress might be a benefit for pumps for T2DM as well. However, these have not been sufficiently examined either and increased security challenges due to integrated peripheral components should not be neglected in terms of a sound cybersecurity. Pump features and handling for patients with T2DM should be as easy as possible, indicating a need for insulin pumps specially designed for patients with T2DM. However, it has to be investigated if pumps designed for T2DM are more effective than other intensified insulin regimens.

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Section: Software For Insulin Pumpsmentioning

confidence: 99%

“…Every unintended insulin delivery has the potential to endanger the user's life or at least to lead to unsatisfactory therapy outcomes. 75 Thus, in the selection of an insulin pump several factors must be taken into account.…”

Section: Barriers and Solutions To Insulin Pump Use In T2dmmentioning

confidence: 99%

Insulin Pump Therapy for Patients With Type 2 Diabetes Mellitus: Evidence, Current Barriers, and New Technologies

Freckmann

Buck

Waldenmaier

et al. 2020

J Diabetes Sci Technol

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“…The large number of adverse-event reports has proven that this practice is inadequate. The FDA recently changed its approval process to be more product focused for infusion pumps, so that the production of an assurance case that demonstrates that the device is safe and effective is now a recommended regulatory requirement in the U.S. [5].…”

Section: Introductionmentioning

confidence: 99%

Envisioning a Requirements Specification Template for Medical Device Software

Wang¹,

Chen

Khédri

et al. 2014

Product-Focused Software Process Improvement

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Abstract. In many health jurisdictions, software is considered to be medical device software (MDS), when it is used to analyze patient data in order to render a diagnosis or monitor the patient's health; when it is to be used by a patient to diagnose an ailment; or when it is used to deliver functionality for a medical device. Flaws in MDS can result in patient harm, including death. Legislators and regulatory agencies publish guidelines and regulatory standards that are aimed at ensuring the safety, security and dependability of MDS. These guidelines and standards universally agree that a complete and consistent requirement specification is vital to the success of medical device software. Moreover, we observe that regulators are shifting from being process focused to being product focused in their approval guidance. In this paper, we review challenges associated with requirements used in the development of MDS, current standards and guidelines relevant to MDS, and existing templates for requirement specifications. We then propose a set of design objectives for a 'good' MDS requirements template and propose a template structure for MDS requirement specification fulfilling all the design objectives. Our template is, by design, tailored to facilitate the gathering and documenting of high quality requirements for MDS.

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“…These failures cause several deaths and serious illnesses. The U.S. Food and Drug Administration (FDA) reported 17,000 adverseevents from 2006 to 2009 including 47 deaths due to IIP's malfunctions [1]. The root causes of these device failures are considered as product design and engineering flaws, which are identified by the FDA officials during investigation of the reported deaths and illnesses related to the IIPs.…”

Section: Introductionmentioning

confidence: 99%