Medical Technology Regulatory Affairs CA2
Table of Contents
Introduction ................................................................................................................................ 1
Factors .................................................................................................................................... 1
Material Selection .............................................................................................................. 1
Design Flaws ...................................................................................................................... 2
Manufacturing Defects....................................................................................................... 2
Software/ Firmware Issues ................................................................................................. 2
Environmental Factors ....................................................................................................... 3
Use Error ............................................................................................................................ 3
Causes .................................................................................................................................... 4
Regulatory Compliance Issues ........................................................................................... 4
Lack of Post Market Surveillance ...................................................................................... 4
Complexity of Devices ...................................................................................................... 4
Inadequate User Training ................................................................................................... 5
Supply Chain Challenges ................................................................................................... 5
Conclusions ................................................................................................................................ 5
References .................................................................................................................................. 7
i
, Medical Technology Regulatory Affairs CA2
Medical Device Failures- An Investigative Case Study
Introduction
Medical devices play a fundamental role in the healthcare industry from facilitating the
diagnosis and treatment of patients to the monitoring of patients. However, despite
advancements in technology and increasingly stringent regulations, medical device failures
remain a significant concern. Faulty medical devices are a leading factor resulting in serious
injuries and death in the United States (Alemzadeh et al. 2013). From 2007 to 2016, there
was more than 5 million medical device failure events reported to the Food and Drug
Administration (FDA). Device failures can cost organisations millions of dollars as well as
requiring significant resources to address the failures (Ellis 2017). The factors and associated
causes involved in medical device failures will be explored below with supporting literature
provided.
Factors
Material Selection
Material failures are a frequent and pricey factor of medical device failures. Ellis has reported
that up to 40% of the FDA medical device recalls between 2013 and 2014 could be attributed
to material failures. Most material failures can be assigned to four primary factors, improper
material selection, issues with raw materials or reagents, poor design of the manufacturing
process and degradation of materials (Ellis 2017).
Initial errors made at the design phase of medical devices can lead to serious failures in the
device at a later stage. Block et al. has said that device designers face numerous difficulties
during the design process including material selection, biocompatibility, manufacturing
techniques. Improper selection of materials for the device application has been the factor
attributed to a multitude of high-profile documented medical device failures. For example,
there have been cases in literature where pacemaker electrodes have been left exposed,
following the pacemaker lead polymeric coating deteriorating over time (Block et al. 2018).
1
Table of Contents
Introduction ................................................................................................................................ 1
Factors .................................................................................................................................... 1
Material Selection .............................................................................................................. 1
Design Flaws ...................................................................................................................... 2
Manufacturing Defects....................................................................................................... 2
Software/ Firmware Issues ................................................................................................. 2
Environmental Factors ....................................................................................................... 3
Use Error ............................................................................................................................ 3
Causes .................................................................................................................................... 4
Regulatory Compliance Issues ........................................................................................... 4
Lack of Post Market Surveillance ...................................................................................... 4
Complexity of Devices ...................................................................................................... 4
Inadequate User Training ................................................................................................... 5
Supply Chain Challenges ................................................................................................... 5
Conclusions ................................................................................................................................ 5
References .................................................................................................................................. 7
i
, Medical Technology Regulatory Affairs CA2
Medical Device Failures- An Investigative Case Study
Introduction
Medical devices play a fundamental role in the healthcare industry from facilitating the
diagnosis and treatment of patients to the monitoring of patients. However, despite
advancements in technology and increasingly stringent regulations, medical device failures
remain a significant concern. Faulty medical devices are a leading factor resulting in serious
injuries and death in the United States (Alemzadeh et al. 2013). From 2007 to 2016, there
was more than 5 million medical device failure events reported to the Food and Drug
Administration (FDA). Device failures can cost organisations millions of dollars as well as
requiring significant resources to address the failures (Ellis 2017). The factors and associated
causes involved in medical device failures will be explored below with supporting literature
provided.
Factors
Material Selection
Material failures are a frequent and pricey factor of medical device failures. Ellis has reported
that up to 40% of the FDA medical device recalls between 2013 and 2014 could be attributed
to material failures. Most material failures can be assigned to four primary factors, improper
material selection, issues with raw materials or reagents, poor design of the manufacturing
process and degradation of materials (Ellis 2017).
Initial errors made at the design phase of medical devices can lead to serious failures in the
device at a later stage. Block et al. has said that device designers face numerous difficulties
during the design process including material selection, biocompatibility, manufacturing
techniques. Improper selection of materials for the device application has been the factor
attributed to a multitude of high-profile documented medical device failures. For example,
there have been cases in literature where pacemaker electrodes have been left exposed,
following the pacemaker lead polymeric coating deteriorating over time (Block et al. 2018).
1
