Embedded Files
These materials form the basis for students presentations in my Medical Software class at Yale (BENG 406b). Some of these are also described in our Introduction to Medical Software textbook in Chapters 17-22.
If you have more examples, or better articles/videos about the stories listed above, please share them with me and I will add them to this list.
Therac-25 (1980s)
Therac-25 (1980s)
This is the origin story of medical device regulations in the United States. The original report is
Leveson NG, Turner CS. An investigation of the Therac-25 accidents. Computer. 1993 Jul;26(7):18–41.
Appendix A of Leveson NG. Safeware: System Safety and Computers. Addison-Wesley; 1995.
Rose BW. Fatal Dose - Radiation Deaths linked to AECL Computer Errors. 1994.
(The video is one of the case studies that from our Coursera Class on Medical Software.)
(See also Chapter 17 of the textbook)
Mars Climate Orbiter: Lost Without A Trace (1999)
Mars Climate Orbiter: Lost Without A Trace (1999)
J. Lynch. The Worst Computer Bugs in History: Rapid unanticipated disassembly of the Mars Climate Orbiter. bugsnug, 12 September 2017.
Mishap Investigation Board Phase I Report. Mars Climate Orbiter, November 1999.
NASA. Mars Mission, Press Kit, December 1998.
(See also Chapter 18 of the textbook)
Healthcare.gov (2013)
Healthcare.gov (2013)
HealthCare.gov: Case Study of CMS Management of the Federal Marketplace (OEI-06-14-00350) 02-22-2016.
"Healthcare.gov builders say testing phase was too short" -- Video from NBC News Oct. 24, 2013.
Another video from The Verge. Why Healthcare.gov came out broken?
(See also Chapter 19 of the textbook)
The 2020 Iowa Caucus App
The 2020 Iowa Caucus App
N. Corasaniti, S. Frenkel, and N. Perlroth. App Used to Tabulate Votes Is Said to Have Been Inadequately Tested. The New York Times, 3 Feburary 2020.
How Stuff Works. How Causes Work: The Iowa Caucus, (Accessed January 2021).
I. Stanley-Becker and M. Scherer. Iowa Democrats kept their App secret to prevent hacks. Instead, they got confusion and chaos. The Washington Post, 4 Feburary 2020.
Clip from MSNBC's coverage of the 2020 Iowa Democratic Party Caucus. (Feb 4, 2020)
(See also Chapter 20 of the textbook)
Boeing 737-MAX Accidents (2019--present)
Boeing 737-MAX Accidents (2019--present)
Office of Inspector General. Timeline of Activities Leading to the Certification of the Boeing 737 MAX 8 Aircraft and Actions Taken After the October 2018 Lion Air Accident. U.S. Department of Transportation; 2020 Jun. Report No.: AV2020037.
Travis G. How the Boeing 737 Max Disaster Looks to a Software Developer. IEEE Spectrum. 2019.
(See also Chapter 21 of the textbook)
WannaCry Cybersecurity Incident (2017)
WannaCry Cybersecurity Incident (2017)
Comptroller, General. Investigation: WannaCry cyber attack and the NHS. Department of Health UK; 2018 Apr. Report No.: HC 414.
BBC TV Video Clip: Cyber Attack: Ransomware causing chaos globally - BBC News
The PIP Breast Implant Scandal (2010s)
The PIP Breast Implant Scandal (2010s)
Kirsh D. PIP breast implant scandal: A story that triggered change. Available from: https://www.massdevice.com/pip-breast-implant-scandal-story-triggered-change/
Martindale V, Menache A. The PIP scandal: an analysis of the process of quality control that failed to safeguard women from the health risks. J R Soc Med. 2013;106(5):173-7.
The Denver International Airport Baggage Handling System (1990s)
The Denver International Airport Baggage Handling System (1990s)
Wayt Gibbs W. Software’s Chronic Crisis. Scientific American. Sep1st, 1994.
U.S. Government Accountability Office. New Denver airport: Impact of the delayed baggage system, 1994.
See also Chapter 3 of the book DeMarco T, Lister T. Waltzing with Bears: Managing Risk on Software Projects. Addison-Wesley Professional; 2013.
Under Construction ...
Under Construction ...
Elekta Cyberattack
Hart A. Cyber attack disrupts cancer care. The Atlanta Journal-Constitution. 2021
Mulcahy N. Recent Cyberattack Disrupted Cancer Care Throughout U.S. WebMD. 2021
Yale New Haven Health able to treat cancer patients again after nearly a week offline due to data breach (WTNH, April 28, 2021.)
Pacheco MF and Suansing R. YNHHS pauses radiotherapy treatment for six days after software breach. Yale Daily News. 2021
These two papers describe related incidents.
Nelson CJ, Soisson ET, Li PC, Lester-Coll NH, Gagne H, Deeley MA, Anker CJ, Roy LA, Wallace HJ. Impact of and response to cyberattacks in radiation oncology. Adv Radiat Oncol. Elsevier BV; 2022 Sep 1;7(5):100897. PMCID: PMC9486427.
Faul C, Robinson J, Carey J, McArdle O, Ryan L, Woods R, McClean B. Effect of the Cyberattack Targeting the Irish Health System in May 2021 on Radiation Treatment at St. Luke’s Radiation Oncology Network. Adv Radiat Oncol. 2022 Sep;7(5):100993. PMCID: PMC9486413
(Thanks to Sanjay Aneja for his help with this.)
EPIC Sepsis Algorithm
Muoio D. Epic’s widely used sepsis prediction model falls short among Michigan Medicine patients. Fierce Healthcare. 2021
Wong A, Otles E, Donnelly JP, Krumm A, McCullough J, DeTroyer-Cooley O, Pestrue J, Phillips M, Konye J, Penoza C, Ghous M, Singh K. External validation of a widely implemented proprietary sepsis prediction model in hospitalized patients. JAMA Intern Med. American Medical Association (AMA); 2021 Aug 1;181(8):1065–1070. PMCID: PMC8218233
Unregulated Algorithms in Healthcare – EPIC and Sepsis. American Council on Science and Health. 2022
Some additional Links & Information
Some additional Links & Information
(Thanks to Andreea Popescu, Hugo Felix and Pratik Patel for the links.)
There are quite a few healthcare ones. Most popular are Tylenol pulled off the shelf in 1982. Great HBR article on it. https://store.hbr.org/product/johnson-johnson-the-tylenol-tragedy/583043. 2. Medtronic StealthStation auto-registration feature. There have been 11 reported injuries. https://www.paulsonandnace.com/six-of-the-worst-medical-device-recalls-of-2020/. 3. Top 10 med device list. https://www.medicaldevice-network.com/analysis/biggest-medical-device-recalls/. (Pratik Patel)
These might be useful https://embeddedartistry.com/fieldatlas/historical-software-accidents-and-errors/ and https://www.pingdom.com/blog/10-historical-software-bugs-with-extreme-consequences (Andrea Popescu)
The Lifescan One-Touch Verio recall in 2013 where the device at extremely high blood glucose levels of 1024 mg/dL and above, would not provide a warning that the blood glucose is extremely high and would shut off, thereby potentially leading to incorrect treatment and delaying proper treatment. (Hugo Felix)
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