Page 203 - Biomedical Engineering and Design Handbook Volume 2, Applications

182 MEDICAL DEVICE DESIGN

The anticipated sterilization method and the intended product application, shelf life, transport,
and storage methods all combine to influence the package system design and choice of packaging
materials. The process of developing a package system seems straightforward and basic. In actu-
ality, the package design process is complicated by the fact that if products are terminally steril-
ized in the sterile barrier system, then the device packages must allow effective sterilization of
their contents by a wide array of methods, and therefore the materials must be compatible with the
sterilization method. Consequently, the sterile barrier system must provide a consistent and con-
tinuous barrier to environmental microorganisms and bacteria so as to maintain product sterility.
The package system must be designed to prevent product damage and loss of functionality from
the dynamic hazards of shock and vibration, which are inherent in the distribution environment.
In addition, the medical device manufacturer must have documented evidence that the perfor-
mance of the package system is not adversely affected, and that it maintains its stability over the
claimed shelf life. The interactions of the materials and product, combined with the manufactur-
ing processes required to bring the product to its end use, influence the package design and man-
ufacturing of the finished product.
The importance of packaging in bringing a medical device to market was illustrated in a speech
by George Brdlik in 1982. These points are no less true today than they were in 1982. Brdlik stated:

Packaging is too often neglected as an important characteristic of a medical device. When sterile medical
devices are involved, deficient packaging can cause the following problems:
• Increased risk of patient infection if product sterility is compromised by defective seals, pinholes frag-
ile packaging materials, or packaging which shreds, delaminates, or tears upon opening.
• Hampering of a surgical procedure because of difficulties in product identification or aseptic trans-
fer, or if a product selected for use must be replaced because the package is either initially defective
or damaged upon opening.
• Increased hospital costs due to discarded products or excessive storage space requirements.
• Increased manufacturing costs for refund/replacement of damaged products and recall of products
with potentially compromised sterility or integrity.
In essence, poor packaging can transform the best, safest, and most economical medical device into an
inferior, unsafe, and expensive product.

This chapter provides a systematic and standardized approach to developing a comprehensive
package system that meets regulatory hurdles and ensures a high degree of confidence that the ster-
ile medical device product will meet its performance specifications at the point of end use. These
elements include
• Selection of materials
• Design of the package
• Package prototyping
• Process validation
• Final package design validation
All of these elements must be combined to produce a package system that meets regulatory,
industry, and consumer’s requirements.

7.2 REGULATORY HISTORY

The regulatory burden for validating the manufacturing process and package system has become sig-
nificant and important. It was started in 1938 with the amended Food and Drug Act of 1906 in which
medical devices were first regulated, and then progressed to the Quality Systems Regulation (QSR)