Page 209 - Biomedical Engineering and Design Handbook Volume 2, Applications

188 MEDICAL DEVICE DESIGN

7.3.2 Identification
Packages must not only provide protection to the product, but they must also communicate what the
product is, instructions, warnings and safety information, and other pertinent information such as, lot
number, sterilization method, and expiration date. Space must be provided on the package for con-
veying this information either by printing directly on the package or by applying a label. Often, there
must be adequate space for the information in two or more languages. The information must be leg-
ible at the point of end use; therefore abrasion, water, and the sterilization process must not damage
the printing and labels.
Specific information regarding label requirements can be found at the following Web site:
http://www.fda.gov/cdrh/devadvice/33.html.

7.3.3 Processability
By processability we mean the ability of the packaging material along with its product to be
processed through a series of manufacturing operations that includes mechanical stresses in filling
and sealing, chemical or physical actions during sterilization, stresses of shipping and handling, and
the environmental effects of aging before the product is finally used. This processability requirement
is clearly stated in 21 CFR Part 820.130, “Device Packaging”:

The device package and any shipping container for a device shall be designed and constructed to protect
the device from alteration or damage during the customary conditions of processing, storage, handling
and distribution.

This statement forms the basis for which the requirement to perform package validation testing is
established and is described in the ISO 11607 standard as “performance testing.”

7.3.4 Ease of Use
Parallel with the increase in the use of disposable medical devices is the requirement for easy-to-
open packages that can provide an application for the presentation of the product into the sterile field.
The package has to be designed such that the materials are strong enough to withstand the rigors of
processing but can be opened without tearing or excessive stress on the package or product.

7.3.5 Special Applications
In some cases the package may serve as a tool in the procedure. The obvious application is as a deliv-
ery mechanism for the product to the sterile field; for example, heart valve holders for aseptic trans-
fer to the surgery site. However, even more complex applications may be designed into the package
to aid in the procedure.

7.4 PACKAGE TYPES

The form the package takes is fundamentally dependent on the characteristics of the device such as
size, shape, profile, weight, center of gravity, physical state, irregularities, sharp edges/points, den-
sity, application of the device, shelf life, and other design inputs.
The medical device industry uses a limited variety of types but many different materials in each
form. Over the past 20 years, the industry has standardized on the following basic medical device
package types.