Pouches were the most prevalent packaging type seen in a recent study of medical device recalls associated with packaging failure. “Out of 60 packaging failure types, 36 were related to pouches, which is equivalent to 60%,” explains Eric Schmohl, customer and application support manager, Tyvek, for DuPont Medical & Pharmaceutical Protection. “All other packaging types range from one to six counts of failure.”
The findings, however, may not necessarily reflect any shortcomings of the format itself, but rather a design's suitability for a given device, explains Schmohl.
Schmohl set out to better understand packaging-related issues in industry, so he decided to examine the numbers behind packaging-related recalls. He assigned a team to research Internet reports from a variety of European countries and from the U.S. FDA. “I wanted to see how impactful packaging design could be, both for the patient and the manufacturer. Packaging is part of a system and deserves more scrutiny and vigilance,” he says.
The team identified 60 packaging-related recalls between January 2011 and July 2013. According to Schmohl, the most results were found on the information pages of the US FDA1 (37), the German Bfarm2 (23), and the British MHRA3 (5). One result each was found under the website of polish URPL4 and Swissmedic5 (total to 64 counts due to four double references). The number of recalls by country of production shows the following numbers: USA (44), Germany (8), UK (5), Ireland (2), Spain (1), and Switzerland (1).
However, in terms of the packaging failures uncovered, “the information found about failure was of various levels of quality. In the majority of cases (24) the failure was described generically as ‘loss of integrity’ followed by ‘defect seals’ (15) and ‘puncture’ (12),” Schmohl reports. (To view results presented in three tables, please visit this blog under the same title in the Medical Packaging Community.)
Such failures are important to examine, because a “single item can be a reason for a patient infection,” notes Schmohl. “Each case could have adverse consequences for a patient.”
Schmohl says he was amazed to see that pouches were most prevalent among the package failures, but acknowledges that the format is used most frequently when compared with header bags and rigid blisters. “The pouch is typically a low-cost option, and it is easy to use and available. It is regarded as a standard,” he says.
To understand the reasons behind the failures, Schmohl says that the team examined the recall statistics by device type. “Surgical instruments, tubing, and implants” were the top three, he notes.
For these three "most failing" device types, “punctures” were found to be a significant occurrence, he says, concluding that the packaging design was inappropriate.
“Pouches are two dimensional, so the device itself should not stress the seals and pressure the seal stability beyond its capability. The use of a pouch should be well assessed.”
Schmohl says that the inappropriate use of a pouch could be attributed to one of the following:
- Filling the capacity of an in-house pouch line also used for other device packaging.
- Using the same type of pouch bought from an external supplier to benefit from economies of scale. This can have the reverse effect of creating a packaging family without applying worst-case principles, according to Schmohl.
The team’s research uncovered a comparably low failure rate for kits, about which Schmohl says he is “positively surprised.”
“Kits often have heavy or sharp products, so you may expect failure from penetration, but that didn’t seem to be the case,” Schmohl says. He believes it could be driven by two reasons: “Kits are often packaged in bags or lidded trays. In the case of bags, bulky medical wrap is often wrapped around the harder, edgy content, thus reducing the risk of puncture.”
Secondly, “the kits do contain more items and are therefore often higher in value, subsequently a more sophisticated packaging design is in use,” says Schmohl. “Rigid or semi-rigid trays are often combined with tear- and puncture-resistant top webs to form a consistent protection shell that still does allow for ethylene oxide sterilization, which is often the industrial sterilization method of choice when a kit or set unit contains materials that do not allow for irradiation.”
Ensuring a package format is appropriate for a given medical device “really depends upon the nature of the device,” Schmohl advises. “Package design and material selection should be subjected to a thorough development process. Manufacturers should be validating package designs, testing the strength and integrity of those packages, and then performing transport simulation tests.”
Schmohl is concerned “that this is not always done.”
“Some may be relying on grandfathering principles when selecting packages. There are quite a few products on the market in a particular configuration because it is thought that after many years with no problems they can conduct the practice,” says Schmohl. “It could also be a matter of cost containment. But MDMs should reconsider and revise their approach.”
Schmohl also acknowledges that some MDMs are lacking “specialization in packaging.” Packaging developers also may be “assigned the task at a late stage when the device is fully developed, and therefore they pursue development in a short period of time and look to a design already in the marketplace rather than reinvent,” he says.
To be able to truly understand the role package design plays in medical device recalls, Schmohl believes that reporting should be improved. “Information about packaging-related medical device recalls was very different between the countries,” he says. “It was perceived that the U.S. FDA, the MHRA of UK, and the German Bfarm allowed for the easiest and most comprehensive information. These first three accounted for 58 recall reports out of 60. This outcome suggests that there is a need to improve and align the medical device recall information quality in the European region.”
Schmohl also advises against drawing any particular conclusions about the higher number of recall reports from these regions. “The high count of failing packaging made in the United States is rather the result of a working vigilance system as well as transparent information systems of the U.S. FDA in place rather than higher rates of quality issues compared to other countries.”
Ultimately, “the EU has to achieve a level of transparency in terms of data. It would allow packaging developers to better understand the risks associated with certain designs. Authorities can help by gathering recall data and categorizing failures,” he says. “Unique Device Identification will certainly help in the tracking process. Gathering data in a more uniform way leads to transparency.”
1. United States Food and Drug Administration, United States of America.
2. Bundesinstitut für Arzneimittel und Medizinprodukte, Germany.
3. Medicines and Healthcare Products Regulatory Agency, United Kingdom.
4. Urzad Rejestracji Produtów Leczniczych, Poland.
5. Swissmedic, Swiss Agency for Therapeutic Products, Switzerland.