OhioHealth

Nikki Ross

Sterile Packaging Authority

How are Changing regulations and new demands from medical device manufacturers, causing packaging and sterilization suppliers to revise and update their offerings?

Due to the ever-changing landscape around this, the medical device industry has found they must explore both their packaging and sterilization services. Tyvek and nylon packaging have been around for years; however, due to the complexity of devices and the types of packaging, it is becoming extremely difficult for these traditional methods and materials to meet stringent regulatory standards. Anytime packaging is changed, it must go through a series of validation testing. 

“Whenever possible, medical device manufacturers (MDMs) still prefer straightforward materials and processes that are already validated and avoid modifications to standard approaches. For example, when a major material or pouch manufacturer changes materials, OEMs must work to validate the new materials.” Your views on this trend.

Often times, when events like this occur, I look at this as an opportunity for OEM’s to re-look at both their processes and packaging materials. This, in turn, can be beneficial and invite cost savings in the future. As time has progressed, most organizations want products that are “green” and can be recycled. 

With increased technological and regulatory challenges, are MDMs starting to realize the value in determining the best packaging and sterilization solutions early in the design process?

I feel MDMs are starting to realize the value in determining the best packaging and sterilization solutions early in the design process. Being a surgical technologist for years, I like to see a product that is easy and quick to use/open. For instance, I prefer clear packaging for containers and pouches so I can visually inspect/see the item before opening onto the sterile field. Although I believe MDMs are focusing on package design today, it has been an afterthought for quite some time. I feel MDMs are gathering more input from key stakeholders than they have in the past and are looking into a variety of different options.

"The most important step for OEMs to take is to obtain input from key stakeholders, identify creative ways to save money, and possibly standardize packaging to reduce the impact on processes and equipment"

The need to reduce packaging costs is a constant pressure. This is especially true for validation and process verification for new products and materials, which can be complex and time-consuming. To streamline production and reduce costs, what can the OEMs do?

The most important step for OEMs to take is to obtain input from key stakeholders, identify creative ways to save money, and possibly standardize packaging to reduce the impact on processes and equipment. 

What are the future trends that you see having an impact on the Packaging and Sterilization industry?

One method of sterilization that comes to mind is the ETO sterilization. It is under scrutiny and is in the process of being eliminated. This, in turn, forces OEMs to revalidate new cycles with new parameters to meet these limits, while others are looking at alternative sterilization processes for validation. All of this takes a significant amount of time, which can affect the overall turn-around of the product. 

What would be your piece of advice to your colleagues and peers?

My piece of advice will be to evaluate all packaging supplies/materials prior to purchasing/ changing products. Proper validation must be offered, and samples need to be given to the end-user to determine they meet the requirements of the organization and AAMI standards.