In general perception, the term “single-use” is often associated with short-lived, low-durability, and low-cost products. Many people imagine such items to have poor resistance against physical, thermal, and environmental factors, while being cheaper and of lower quality compared to reusable alternatives.

However, in the field of single-use polymeric medical devices, this perception is entirely different. Due to their critical applications in hospitals and operating rooms, these devices must not only meet but actually exceed the highest levels of safety, hygiene, and performance standards (ISO 13485, 2021; FDA, 2020).

Unlike general polymeric products, medical single-use devices require:

•The use of high-grade, biocompatible raw materials (ISO 10993, 2018)

•Precise and delicate design, considering clinical sensitivities

•Prioritization of patient safety over economic cost

•Special conditions for sterilization, packaging, and storage (EN 556, 2002)

These requirements redefine the meaning of “single-use” in medical technology.

A significant proportion of single-use polymeric medical devices are utilized in:

•Operating theaters and surgical procedures

•Sterile hospital wards

•Clinical and laboratory centers

The critical nature of these environments demands equipment that is meticulously designed and manufactured, since even minor contamination may lead to severe consequences for patient health (Zhang et al., 2019).

For a single-use polymeric device to perform successfully in clinical practice, it must be produced under strict conditions, including:

1. Controlled and hygienic production environments (Clean Rooms)

2. Manufacturing processes tailored to product sensitivity (e.g., precision injection molding, medical extrusion)

3. Use of specialized medical-grade raw materials distinct from industrial polymers

4. Continuous and multi-stage quality control (FDA, 2020)

5. Dedicated machinery for medical device production

6. Packaging and sterilization under validated conditions (ethylene oxide gas, gamma irradiation, etc.)

Despite their “single-use” designation, these products must exhibit:

•High precision and manufacturing quality

•Biocompatible and specialized raw materials

•Secure sterilization and packaging

•Sophisticated design and dedicated production mechanisms

•Clinical safety and reliability

Therefore, a single-use polymeric medical device is not a simple disposable item, but rather the outcome of advanced technology, strict standards, and sensitive design (Ratner et al., 2013).

Contrary to the common perception of disposable products as cheap and low quality, single-use polymeric medical devices are among the most complex and sensitive items in the healthcare industry. Adherence to international standards, use of specialized raw materials, and highly controlled production processes ensure patient safety and treatment quality in this critical sector.

Mohammad Azadeh Ranjbar

References

•ISO 13485: Medical devices – Quality management systems – Requirements for regulatory purposes.

•ISO 10993: Biological evaluation of medical devices – Part 1: Evaluation and testing.

•FDA. Medical Device Quality Systems Manual. U.S. Food and Drug Administration.

•EN 556: Requirements for medical devices to be labeled “STERILE.”

•Ratner BD, Hoffman AS, Schoen FJ, Lemons JE. Biomaterials Science: An Introduction to Materials in Medicine. Academic Press.

•Zhang X, et al. Polymeric Materials for Medical Applications. Journal of Biomaterials Applications.