Activity 5.1.1 – Biomedical Guidelines

Introduction

Sometimes it seems as though we are living in a science fiction life. People today have their hearts removed and someone else’s put into them. In France, a woman had someone else’s face replace her badly damaged one. Hips are removed and replaced with mechanical ones. Perhaps, a relative has had a mechanical heart valve replaced last week. Products are introduced to the medical field everyday, products which are meant to improve our quality of life. However, even in this science fiction world of today, mistakes are made when these routine operations are performed.

What legal and business aspects are associated with these engineering marvels? Have you heard about any law suits which have been brought forward because some mechanical implant failed? Here is your chance to find out.

In this activity, you will be asked to use the internet to learn about these medical mistakes and to apply Product Development Lifecycle to product failure and liability.

Equipment

  • Computers with Internet access
  • Microsoft software
  • Product Development Lifecycle

Procedure

  1. As a group, access the Internet and search for three product failure case studies in the biomedical field (hint: start with a medical device and then look up failures for that device). Read each case study and, as a group, select a case of interest.
  1. Apply Product Development Lifecycle to the case study your group selected. This lifecycle can be found on the class weebly page.
  1. Answer the conclusion questions as a means of evaluating the case study.
  1. Create a presentation (prezi, animoto, go animate) as a way of summarizing the conclusion questions. Include pictures or diagrams of the facilities used to manufacture the product from the case study. Your presentation should be posted on each of your teammates websites.

Conclusion

  1. What was the need, at the time, for the product?

A replacement shoulder joint for people with extreme cases of arthritis or with a disabled shoulder.

  1. What alternate solution, design, or improvement was proposed for the product?

Possible remaking of the bone to be put back( rebuilt shoulder )

  1. What new processes developed as a result of the product dilemmas?

Different materials used for the top of the humeral head and glenoid.

  1. What different prototypes were developed for the product?

Possible other designs were a variety of different forms of the ball joint.

  1. What are some current problems with the product? How have these problems impacted society?

The Zimmer shoulder replacement has problems where as the humeral head and the glenoid separated, slowly, causing the shoulder to dislocate. This has impacted society because it caused another surgery to cement it back together.

  1. What documentation exists for the testing results of the product?

FDA enforcement report contains testing results.

  1. What are some quality control procedures used in product testing?

gentle rehabilitation program to help relax the muscles around the new shoulder.

On the day of surgery you may be encouraged to get out of bed and take a few steps.

receive pain medication as needed,

bandage will be removed about two days after surgery.

remain in the hospital from one to three days. shoulder area may be warm and tender for several weeks.

physical therapist will show you how to perform the rehabilitation exercises that are important for your recover.

  1. Is your product still in use today? Has it been replaced? Has it been improved?

The product has been improved, a better bone concrete has been used during the surgery keeping the humeral head and glenoid together

  1. What are the technological challenges of improving your product design and function?

The ball joint and the cuff must fit perfectly cealed with a sturdy material so the shoulder and humerous wont separate.

  1. What regulations, guidelines, or practices would ensure higher product safety and function for your product?

A steady physical therapy, and shoulder monitoring would keep this product more safe.

  1. What are the governmental regulations associated with your selected case?

There was an ordered zimmer shoulder replacement recall by the government.

  1. What are the manufacturing issues associated with your selected case?

The metal ball joint and cuff must be manufactured precisely, it is hard to mass produce.

  1. What are the safety issues associated with your selected product or case?

Possible infection of the shoulder, and glenoid and humerous separating from the shoulder and arm could occur

  1. Did the product fail?
  • If yes, why?

It did because the glenoid and humerus separated in several customers but they did fix the product.

  • What improvements could have been made to eliminate the product failure?

Different material that didn’t wear out as easy and stronger pins or bone concrete to keep the shoulder and arm from separating.

  • How could those changes have been cost effective?

The could be cost effective if the different material is more costly or if the surgery takes more time to ensure the proper installment of the zimmer shoulder.

  • How could the improvements have allowed for product reliability and/or reusability?

The shoulder will now be more durable and secured better with new pins into the glenoid or a better bone concrete to bond the glenoid and humerous.

  • Was the product failure a liability for the engineer or the company? Why?

yes it was because it was their product and a good percentage of the patients had the same problem of a separated shoulder so their was a recall.

Project Lead The Way, Inc.

Copyright 2010

PLTWTM - BE – Unit 5 – Lesson 5.1 – Activity 5.1.1 – Biomedical Guidelines – Page 1