This project has four sections and requires you to read and understand an assigned paper, and apply the concepts in the paper to what you have learned in a lecture.

The paper is the James Reason paper on Human Error (the Swiss Cheese Model of System Accidents).

The lecture is Josh Simons on industrial development of medical devices. Joshs lecture detailed all of the steps (management, technical, QA, regulatory, etc.) in the development of a medical device

Project: Imagine you are a company developing a new total hip replacement device.

1) Part One: How can each aspect of medical device project development be represented by the layers of Swiss cheese in the theory? Note: Some aspects of the project life cycle are best represented by multiple layers of Swiss cheese. Which parts of the project life cycle (and Swiss cheese layers) are involved with design, preclinical testing, clinical testing, and quality assurance aspects, and other aspects of the project? How could the holes in each layer of Swiss cheese contribute to a complex failure? Which aspects of the project life cycle can be represented by more than one layer of Swiss cheese? Where would FDA approval fit in the process? Specifically, you need to make a detailed list of the aspects of project development, and describe a corresponding layer of Swiss cheese, and how defects (holes) in each layer could contribute to complex failure for this particular project. If you would like to use a chart, table, or hand drawing for this organization, please do so (as long as I can understand it).

2) Part Two: Imagine that this total hip replacement makes it into clinical use, but suffers from unanticipated fatigue failures of the femoral neck of the implant. The company needs to correct this issue. How would the company do this? Assume that the holes in more than one layer of Swiss cheese must have lined up to allow these failures. Which parts of the project life cycle and Swiss cheese layers would be evaluated and changed? If you were the project manager, how would you proceed to fix this device? How many steps (Swiss cheese layers?) would be involved, and what should be done with each layer?

3) Additional Question: Which of the layers (and holes) represent active failures versus latent failures. Justify your answers.

4) Additional Question: Finally, as the project manager, how could you work with company management to make sure this type of complex failure doesnt happen again? What specific aspects of project development would you change and how?

Education and debate

Human error: models and management

The human error problem can be viewed in two ways: the person approach and the system approach. Each has its model of error causation and each model gives rise to quite different philosophies of error manage- ment. Understanding these differences has important practical implications for coping with the ever present risk of mishaps in clinical practice.

Person approach

The longstanding and widespread tradition of the per- son approach focuses on the unsafe actserrors and procedural violationsof people at the sharp end: nurses, physicians, surgeons, anaesthetists, pharma- cists, and the like. It views these unsafe acts as arising primarily from aberrant mental processes such as for- getfulness, inattention, poor motivation, carelessness, negligence, and recklessness. Naturally enough, the associated countermeasures are directed mainly at reducing unwanted variability in human behaviour. These methods include poster campaigns that appeal to peoples sense of fear, writing another procedure (or adding to existing ones), disciplinary measures, threat of litigation, retraining, naming, blaming, and shaming. Followers of this approach tend to treat errors as moral issues, assuming that bad things happen to bad peoplewhat psychologists have called the just world hypothesis.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1117770/

please find an Attached link is connected to the article mentioned above "the James Reason paper on Human Error (the Swiss Cheese Model of System Accidents).

Thank you very much.