Medical Plastic Data Service Magazine



Our 30th Year of Publication
Page  2 of 5

Cover Story



Dr. R. Rangaprasad
Business Head

Definition of a Medical Device


The Global Harmonization Task Force (GHTF) proposed the following harmonized definition of a medical device:


Any instrument, apparatus, implement, machine, appliance, implant in vitro reagent or calibrator, software, material, or other similar or related article.

Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:

• Diagnosis, prevention, monitoring, treatment, or alleviation of disease.
• Diagnosis, monitoring, treatment, alleviation of, or compensation for an injury.
• Investigation, replacement, modification, or support of the anatomy or of a physiological process.
• Supporting or sustaining life.
• Control of contraception.
• Disinfection of medical devices.
• Providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body, and

b. Which does not achieve its primary intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its intended function by such means.

By definition, devices are involved in many different aspects of healthcare. As such, devices, their manufacturing processes, and the packaging that contains and protects them are extremely disparate. Complicated capital equipment, such as MRI tunnels and X-ray machines, are medical devices, but so are simple, commodity-like items such as tongue depressors and syringes. Some are meant for mass markets; others are niche items. Some are packaged individually; others are packaged in boxes of 100 s or 1000 s. Some are reprocessed, others are disposable, and some are used for a lifetime. Risks associated with device misuse and failures are equally varied, ranging from inconvenience to patient death.

Classification of Medical Devices

The great variation present in the medical device industry means that devices can be classified in a number of ways.

Devices can be categorized by:

• The risk associated with improper use or a failure (generally high, moderate, and low).
• Conditions of processing (reusable, disposable, capital equipment, etc.).
• Conditions of the therapy (invasive, noninvasive).
• Conditions of shipping and handling (capital equipment, commodity surgical, etc.).

Because the goal of these therapies is to maximize efficacy and protect patient safety, the most common way to classify devices is based on risk.

Key Considerations for The Development of Medical Device Packaging

In addition to the normal functions of a packaging system, the following requirements are unique to Medical Devices.

Sterile Barrier System

The vital importance of maintenance of the sterile barrier system (SBS) is a distinctive characteristic of medical device packaging. Medical device packaging for disposables must not only maintain the SBS but, in many cases, also facilitate the sterilization of the device within. Such protective characteristics can be achieved
through the package shape, particularly in thermoformed parts, in order to avoid product shifting or to keep kit components separated or nested. For sealed packages, seal integrity is an important characteristic in product protection. Seals must be free of channels and must withstand the rigors of sterilization and transit.



Utility is related to the ease of use of the system. For many medical devices, quick and easy opening and removal of contents are crucial. While this consideration is also important for devices with relatively low risk, such as an adhesive bandage, it is extremely critical for sterile medical devices that are used in surgical arenas where the packaging must allow the device to be removed without contamination. This particular need has led to the development of special materials and sealants that, when used in combination, can provide package strengths that are adequate to endure the severity of processing and, at the same time, can be manually opened without imposing excessive stress on product or user.


As with consumer goods packaging, secondary and primary medical device packages are a means to convey information through graphics, materials, and shape. Packaging
communication operates at different levels, depending on the type of medical device.

For over-the-counter (OTC) medical devices, such as condoms, glucose meters, adhesive bandages, thermometers, and so on, the communication role involves motivating a purchase, as well communicating important information for the safe and effective use of the medical device. Information may include directions, warnings, product benefits, brand differentiation, and so on. A very important aspect of package communication is product identification. This is especially true for devices that go into institutional settings, such as hospitals, where personnel may have to identify the correct device for a patient when seconds count.

Key Package Design Considerations

During the early design stages, it is critical to define the following parameters:

  • Critical product characteristics.

  • Type(s) of protection required (physical, ultraviolet light, O2, water vapor transmission, etc.).

  • Type of sterilization process.

  • Where and how the product is going to be dispensed (OTC, surgery, etc.).

Medical device packaging requirements

Complying with packaging requirements is the responsibility of the medical device manufacturer. This is the only way to guarantee that the products will be protected during transportation, and that they comply with health and safety regulations.

Pharmaceutical and medical products have certain special characteristics (such as their limited shelf life). For this reason, their requirements for transportation and commercialization must be aligned with them.

The protocols aimed at guaranteeing their safety focus on factors such as the seal integrity, materials or how the package reacts to the passage of time.

At a government level, the most important regulations are those of the Food & Drug Administration (FDA) in the United States, and the Medical Devices Directive in the European Union.

Medical device packaging doesn’t just need to arrive at the hospital, clinic, or end customer free from holes, tears or missing seals; it must also withstand the passage of time in storage, where it must be able to remain for years without the drug or device having their composition altered..

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