Failure Modes in Medical Device Software: An Analysis of 15 Years of Recall Data

Wallace, Dolores R; Kuhn, D. Richard

doi:10.1142/s021853930100058x

Cited by 147 publications

(75 citation statements)

References 10 publications

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“…There is evidence that the increasing complexity of IMD software is already taking a toll on the biomedical industry. From 1983 to 1997, 6% of the recalls issued for medical devices containing software were attributable to software failures [25]. From 1999 to 2005, 11.3% of the recalls were attributable to software failures, a near doubling of the software-related recall rate [2].…”

Section: Hardware Vs Software Security Risksmentioning

confidence: 99%

Recent Results in Computer Security for Medical Devices

Clark

2012

Lecture Notes of the Institute for Computer Sciences, Social Informatics and Telecommunications Engineering

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Abstract. The computer security community has recently begun research on the security and privacy issues associated with implantable medical devices and identified both existing flaws and new techniques to improve future devices. This paper surveys some of the recent work from the security community and highlights three of the major factors affecting security and privacy solutions for implantable medical devices: fundamental tensions, software risks, and human factors. We also present two challenges from the security community with which the biomedical community may be able to help: access to medical devices and methods for in vitro experimentation.

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Section: Hardware Vs Software Security Risksmentioning

confidence: 99%

Recent Results in Computer Security for Medical Devices

Clark

2012

Lecture Notes of the Institute for Computer Sciences, Social Informatics and Telecommunications Engineering

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“…Safety is a key area which must be successfully addressed given the potential for harm that defective medical device software can cause. An analysis of medical device recalls by the FDA in 1996 [40] found that software was increasingly responsible for product recalls: In 1996, 10% of product recalls were caused by software-related issues. The standards and guidelines created to overcome this have already been discussed, but problems still persist.…”

Section: X228 Traceability For Medical Device Software Developmentmentioning

confidence: 99%

Medical Device Software Traceability

McCaffery

Casey

Sivakumar

et al. 2011

Software and Systems Traceability

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Software traceability is central to medical device software development and essential for regulatory approval. In order to comply with the regulatory requirements of the medical device industry it is essential to have clear linkages and traceability from requirements -including risks -through the different stages of the software development and maintenance lifecycles. The regulatory bodies request that medical device software development organizations clearly demonstrate how they follow a software development lifecycle without mandating a particular lifecycle. However, due to the traceability requirements of the industry most medical device companies adopt the V-model. Within this chapter we will discuss the importance of traceability to medical device software development, the current state of practice within the industry in relation to traceability and how we feel that traceability could be improved within the industry. The chapter also describes the development and implementation of a medical device traceability software process assessment method (Med-Trace) in two medical device software development organizations. We include these two case studies as one involved a medical device SME based in Ireland and the other a medical device SME based in the UK as we want to illustrate that Med-Trace can be applied within different countries.

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“…An analysis of medical device recalls by the FDA in 1996 [33] found that software was increasingly responsible for product recalls. This continues to be the case and in the period the 1 st January 2010 to 1 st January 2011 the FDA recorded 80 medical device recalls and state software as the cause [46].…”

Section: Regulatory Nature Of the Medical Device Domainmentioning

confidence: 99%

Verification & Validation in Medi SPICE

Sivakumar

Casey

McCaffery

et al. 2011

Communications in Computer and Information Science

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Abstract. Effective verification and validation are central to medical device software development and are essential for regulatory approval. Although guidance is available in multiple standards in the medical device software domain, it is difficult for the manufacturer to implement as there is no consolidated view of this information. Likewise, the standards and guidance documents do not consider process improvement initiatives. This paper assists in relation to both these aspects and introduces the development of processes for verification and validation in the medical device domain.

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Failure Modes in Medical Device Software: An Analysis of 15 Years of Recall Data

Cited by 147 publications

References 10 publications

Recent Results in Computer Security for Medical Devices

Recent Results in Computer Security for Medical Devices

Medical Device Software Traceability

Verification & Validation in Medi SPICE

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