Importance of Medical Device Packaging Validation

Proper packaging of medical devices is almost as important as the devices themselves. Without adequate medical device packaging standards, patient safety could be at serious risk. Ensuring that these standards are met requires regular medical device packaging validation so that the devices within can be opened and used with a great deal of confidence that they’ve remained sterile through the packaging, storage, handling, transportation and delivery process.

Here are some of the many reasons why medical device packaging validation is so critically important.

Medical Device Packaging Validation

Sterile Integrity – First and foremost, routine validation ensures that the devices within the packaging remain completely sterile at all times. This is vital, as even the slightest contamination could result in serious health risks to the patient being treated, up to and including death. As such, the validation process involves careful inspection to verify that there are no pinholes, cuts or tears in the pouch packages. These types of defects can occur at any point during the process, from handling to storage to vibrations that occur during transport or even as a result of being dropped.

Standards and Regulatory Compliance – Given the consequential nature of medical devices and how they will eventually be used, the government has set forth a number of stringent standards and regulations which must be closely adhered to by device manufacturers. Performing routine validation helps to ensure that these medical device packaging standards are consistently met to avoid any potential disciplinary actions.

Identify/Correct Errors – Certain things, such as using the incorrect package type or material, can be avoided when validation is carried out on a regular basis. Not only can these types of costly errors be identified, corrected and avoided in the future, but in doing so, manufacturers can better determine improved ways of packaging. For instance, using a plastic that’s designed to withstand high impact on larger devices can reduce the possibility of damage and fracturing that can often occur in lesser-grade packaging during normal handling and distribution.

Identify False Positives–Occasionally, false positives will occur, such as a supposed sheet separation that appears when the packaging material becomes bent, wrinkled or folded. In most cases, it’s been proven that these types of things do not actually impact the sterile barrier of the material. With a quality medical device packaging validation process, these false positives can be recognized as such so that time isn’t wasted, nor is material scrapped for no reason.

Protocol Development – Engaging in regular medical device packaging validation aids in the development and implementation of protocols and best practices. This essentially allows device manufacturers to create blueprints for how future testing should be done, including such important factors as purpose, scope, parameters, responsibilities, production equipment, settings and acceptance criteria. This ultimately helps to prevent problems from occurring down the road.

Given the critical importance of packaging for medical devices, it’s obvious that routine validation is absolutely necessary to ensure ongoing compliance. To learn more about Van der Stähl Scientific’s full line of medical device packaging validation and inspection systems, click here or contact us today at 800-550-3854.