Desperately Seeking Safety: Making Sense of Sterile Package Defects

Recall. A single word that is quick to grab the attention of anyone that is familiar with the medical device industry, including both device manufacturers and patients. Manufacturers of medical devices are in the business of improving public health; therefore they have to err on the side of safety when it comes to voluntarily recalling sterile packages that are believed to be defective. As a result, one of the major reasons for packaging-related recalls in the device industry is listed as “defective packaging: POTENTIAL for breach in sterility.”“Potential” becomes the operative term. If a manufacturer finds a defect, they remove the packaged product from distribution. It is removed, not because it has a KNOWN breach of integrity, but because there is a POTENTIAL for it. As a safe, but costly approach, if a defect is detected, the entire lot is likely to be pulled.These types of recalls have many root causes including, but not limited to, machinery issues, material concerns and the rigors of distribution. The Institute of Packaging Professionals (IoPP’s) Medical Device Packaging Committee has formed a task group to study sterile package “hole” sizes to help reduce confusion related to this subject matter in the future. Little is known about precisely what size defect will allow for a breach of sterility, and what size breach poses no threat to the patient.The goals of enhancing patient safety and reducing costs surrounding packaging related recalls have inspired the IoPP task group to apply science to answer the question: “What defect size presents a danger in medical device packages?” so that:

• Patient safety is maximized
• Informed decisions can be made in the event of a potential recall situation
• A sensitivity benchmark is established for integrity testers
• Costs are minimized (packages and products are not thrown out unnecessarily).

The subcommittee has agreed to the following experimental objectives:

1. Identify the minimum hole size(s) through which Bacillus athrophaeus (previously named Bacillus subtilis) and E. coli K-12 penetrate a rigid tray when temperature and relative humidity (RH) are standard and gravity serves as the driving force across the breached barrier;
   
   
2. Identify the minimum hole size(s) through which Bacillus athrophaeus and E. coli K-12 penetrate a rigid tray when temperature and RH are standard and the package is subjected to pressure differentials that simulate those recorded during flight.

Supporting this effortThe results and conclusions of these tests will help to establish sterile packaging benchmarks for years to come.Companies that have contributed to the start-up effort include:

• Amcor Flexibles
• Belco Packaging Systems
• Cardinal Health
• C.R. Bard
• DuPont
• GWY Technologies
• Medtronic
• Mocon
• Perfecseal
• Sabin/Cook Corporation
• SenCorp, Inc. and
• Smith and Nephew, Inc.

To continue the work, equipment, personnel, and monetary donations are necessary; it is estimated that the proposed experiments will cost approximately $400,000. The School of Packaging at Michigan State University is serving as the research agent to create, conduct, and document the test sequences.If you or your company would like to get more involved, please contact Karen Polkinghorne (DuPont) at[email protected]or Randy Troutman (Smith and Nephew, Inc.) at[email protected]. Contributors will be provided with an executive summary of relevant findings.