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Validating heat sealers, dye penetration and burst tests, the consequences of designing packaging late in the product design process, and sterilization issues are among the topics that Jacob Kearns has answered in the past year on his "Medical Device Blog." Kearns is an engineer for a medical device company. Differing points of view may be shared on this blog.
Pharmaceutical firms seek packaging line improvements to cut costs, biologics present packaging challenges, and medical device growth is driven by aging baby boomers. These treatment advances bode well for the healthcare/life sciences packaging community. Packaging materials need to offer protection from point of manufacture to the “last mile” where healthcare products reach a patient. Packaging materials must provide barriers for moisture, oxygen, light and heat, and they may include overt and/or covert security measures to combat counterfeiting and diversion. Equipment will need to package products more efficiently, be validatable and versatile.
At the Pharmaceutical Packaging Forum, Attorney Eric F. Greenberg revealed key Food and Drug Administration issues pertaining to healthcare packaging. Among them were drug safety, inspections, cGMPs, labeling of prescription and OTC drugs, and how a unique coalition came together last year to lobby for more FDA funding.
The Food and Drug Administration continues to be challenged by limited financial resources. That was one of the messages from Donald E. Marlowe, FDA agency standards coordinator, during his March 8 keynote address that launched this year’s HealthPACK medical device conference in New Orleans. “Packaging is one of the most important issues in designing medical products,” Marlowe told an audience that by unofficial count was about 160. He also said “packaging contributed to the largest number of product failures,” although not recalls. The problems included mislabeling and seal failures.
Once a Food and Drug Administration recall is initiated, a company is responsible for evaluating the progress of the recall of the medical device, drug, biological product, or package, and providing routine updates to the FDA. The three parts of a recall evaluation include the following:
1. An effectiveness check is necessary to verify that the notification letter was received by the customer and that the recalled product has been handled appropriately. For more information, see methods for conducting recall effectiveness checks.
2. A recall status report is routinely provided to the local FDA district recall coordinator. One of the components of the status report is the determination of the root cause. In addition, the report includes the number of customers notified and the customer responses.
3. In order to terminate the recall, all product possible must be recovered. Once this occurs and the disposition of the recalled product has been completed, a final status report can be generated.
If a company is not willing to remove from the market a medical device, drug, biological product, or package that poses a significant health hazard to consumers, the Food and Drug Administration will request a recall in writing. Once the request from the FDA is received, a recall must be initiated by the manufacturer, utilizing the internal approved strategies discussed in last month’s column.
If the product has been distributed to consumers, drafting a press release should be the manufacturer’s first step. The manufacturer needs to determine whether this communication should be local, regional, nationwide, or global. For the broadest coverage, sending the press release to a news service such as the Associated Press might be appropriate. To expedite the recall, the press release should contain at least the following information:
When a medical device, drug, or biological product or package poses a public health risk, either to humans or animals, a recall must occur. The determination of the risk and the initiation of a recall can be by a manufacturer, at the request of the Food and Drug Administration (FDA), or by the FDA order under statutory authority.
In order to be prepared in the event of a recall, here are three steps recommended by the FDA:
1) A strategy should be in place to define the initiation and execution of a recall. A few items that ought to be included in the strategy are details on the notification of the FDA District Recall Coordinator, the depth of recall, and if public warnings are necessary.
2) The identification of the medical product(s) by lot number. While carrying out a recall, the ease of product identification can make an effective recall possible.
3) The initiation and maintenance of records for determining the location of distributed product to be recalled.
“The recent recall of the popular drug Vioxx is an example of how a company can respond to crises in an organized and responsible fashion,” says Rogelio Rodriguez, director of Engineering and Science Programs for the University of California-Irvine Extension. “Now, more than ever, companies are realizing the value of having a long-term crisis management plan in place.”
Does packaging fit into that plan? Yes, says Rodriguez, recollecting the Tylenol poisoning of the 1980s. “How you package, label, and comply with the Food and Drug Administration’s regulations,” he lists as examples.
Recent regulatory and marketing changes in the life sciences industry prompted the UC-Irvine Extension to begin a two-day class called Medical Product Crisis Management, aimed at providing professionals in the medical industry with guidelines on how to develop an effective crisis management plan. The first course was held in late August. Rodriguez expects the class to be offered twice a year; the next time in January. Medical Product Crisis Management is an elective course that’s part of the Extension’s Medical Product Development Certificate Program.
