Recent events highlight the complex role packaging plays in the delivery of medical devices to the consumer. For example, in the ever-closer worlds of medicines and medical devices, a fungicide used to treat wooden pallets is thought to have metabolised into the chemical 2, 4, 6 tribromoanisole (TBA), which impregnated the packaging.

The chemical produced a musty odour, which was reported in consumer complaints, with some claiming gastronomical distress from the ingestion of the product.

In this kind of scenario, the reflexive reaction of the medical device industry is to review quality management systems (QMS), do root-cause analysis and develop new tests to get things back on the straight and narrow, and the industry has already seen the development of a pallet purity programme (PPP). A PPP is one approach to the problem. While it may not fully deal with the FDA’s concerns – a QMS based on design – it lays an excellent foundation to understanding how quality by design affects medical device packaging.

FDA and the role of packaging

A brief review of FDA thinking on the role of packaging in the QMS of a medical device is in order. Here, the FDA specifies three tasks for packaging medical devices:

  • Protection/safety: “… protects the device during handling and shipping and from the environment and micro-organisms until the package is opened.”
  • Labelling: “packaging contains the product identification and other information…”
  • Ease of use: “… when the consumer is ready to use the product, the package should be easy to open without compromising the quality of the device.”
“As well as developing a PPP, manufacturers will turn to pallet suppliers and supply chains for help.”

In fact, the FDA is explicit about packaging’s role in the supply chain. “The total device and package system should be considered with respect to: device characteristics, sterilisation process if any, sealing, labelling, secondary packaging, handling, shipping, environment, storage, federal regulations and end use.”

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Hindsight is 20 / 20, so there is some clarity now that pallets are an important element regarding handling, shipping, environment and storage. So what happened? The FDA has moved from a ‘quality by testing’ (or documenting) to a ‘quality by design’ approach.

Moreover, the FDA is focusing on the lifecycle of the medical device. Perhaps the TBA issue is an almost textbook example of why the FDA’s thinking has changed.

Quality resources devoted to packaging have traditionally operated on some sort of triage approach. Resources are limited, there is a strong business need to get products approved, and therefore the quality review of a product reflects this reality. The result is a concentration on primary packaging and all packaging elements directly related to the approval of the device (especially labelling) with a corresponding weakening in the review of tertiary packaging or handling/shipping/environment issues that do not directly affect the testing necessary to gain device approval.

The cultural gulf between this approach and the FDA’s quality by design thinking is large. The development of a package design space, understanding the total lifecycle of the device (and its packaging) and the use of risk analysis tools normally seen as the realm of device manufacture are just now reaching the world of device packaging.

Here’s where the FDA’s approach differs from traditional thinking. A conventional approach to the current dilemma consists of creating PPPs (or a similar strategy) and looking for ways to test and document that the pallets in their system are TBA-free. It reacts to the situation rather than getting out in front of it.

As well as developing a PPP, manufacturers will turn to pallet suppliers and supply chains for help. There is a not insignificant materials war going on between wooden and plastic pallet manufacturers. Sorting out good data from sales spin is difficult in normal circumstances, but it can become a major challenge.

The TBA problem illustrates the FDA’s frustration with traditional QMS approaches. A PPP or similar programme results in increased testing, time, costs, regulatory burden and often confusing information from suppliers (such as plastic vs wooden pallets). The FDA points to another approach.

Post-design medical device risk management

A post-design medical device risk management approach for packaging that looks at the lifecycle of the product and risk management issues offers the device manufacturer significant advantages. Such an approach addresses both the FDA’s QSR approach and ISO 14971.

“The tribromoanisole issue can serve as a wake-up call for medical device packaging.”

The risk analysis, evaluation and control steps of the management process are applicable to packaging. It is important to note that packaging is not just primary packaging, but secondary and tertiary as well, or to use FDA terminology, a ‘total lifecycle’ approach to understanding packaging risk for a medical device. The approach is structurally more robust than traditional thinking.

A reactive approach to the TBA issue might be either launching a major PPP initiative to assure ‘pure’ pallets or switching to plastic pallets.

A proactive approach does a periodic risk analysis and evaluation, which not only can come up with a risk control strategy to deal with the current issue (TBA), but may also identify other, as yet unseen, risks and intercept them before they can cause any effect.

The risk analysis and evaluation steps offer medical device companies a way to balance their evaluation of primary, secondary and tertiary packaging. In traditional QMS systems, tertiary packaging receives little attention.

In risk analysis, the entire lifecycle process of the packaging is reviewed for possible hazards and risks. The result is a much higher probability of identifying a problem before it happens.

The TBA issue can serve as a wake-up call for medical device packaging. It shows the need to incorporate risk management to look at the total lifecycle of the device and it offers a way to package devices with safety and integrity rather than with vulnerabilities.