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ISO 13485 & MDR Blog

Managing cleanliness of a product and contamination control according to ISO 13485:2016

Most medical devices interact with the human body during the surgical process; just imagine if we didn’t have a cleaning process or sterilization process in place. Then, all of those medical devices would transfer physical debris (weighing in micrograms) into the exposed human body during the surgical process, or transfer biological agents into the body, ultimately causing various serious infections and other biological reactions. Such surgical processes would pose serious health risks and hazards. Therefore, ISO 13485 mandates cleaning and sterilization processes.

The sterilization process should not be confused with the cleaning process, although both are among the most important processes during the manufacturing and delivery of a medical device. The process of sterilization focuses on decontamination or removal of biological agents, whereas the cleanliness of a medical product relates to a cleaning process that removes physical micro impurities from a device.

Requirements for cleanliness of a product

ISO 13485:2016 focuses on cleanliness during the assembly and packaging processes. Some new requirements have been added in ISO 13485:2016, as compared to the previous standard.

Overall requirements for cleanliness of a product in ISO 13485:2016 are:

  1. List devices that organizations clean before sterilization or use – the organization is required to maintain documents for cleanliness or contamination control requirements for devices that are cleaned. Most of the surgical devices require cleaning before sterilization.
  2. List devices that cannot be cleaned before sterilization or use – there are certain medical devices that cannot be cleaned before sterilization, or cleaning before sterilization won’t add significant value. These devices need to be listed, and requirements for cleaning after sterilization or use have to be documented.
  3. List devices delivered non-sterile to be cleaned before sterilization or use – there are contract manufacturing companies that supply non-sterile medical devices to trading organizations. Those devices have to be cleaned before sterilization or use. Therefore, documentation should list those devices and contamination control requirements to be developed after they have been delivered.
  4. List devices that must be cleaned during use, but are delivered non-sterile – documentation should specify cleanliness or contamination control requirements for devices that are supplied non-sterile, but whose cleanliness is a significant requirement in use.
  5. List all process agents that must be eliminated from the product during manufacturing – along with this list, contamination control for process agents should also be documented.

Work environment and contamination control

ISO 13485:2016 sets requirements for work environment and contamination control. The organization is required to control work conditions. The organization must identify and document the work environment, work conditions, and contamination control that influence the quality of surgical instruments. For example, in an area where instruments are belt grinded, debris of the grinded material remains in the environment, with the product, and on the floors. The neighboring stations can be affected and contaminated from this process. Therefore, the organization should barricade such areas, increase floor cleaning frequency, clean products before transferring them to other processes, and ensure proper containment of the source with a dust collector.

A procedure must be developed to examine and monitor the working conditions. The organization must list all personnel who affect the quality of medical devices, along with their health, cleanliness, and clothing requirements. These requirements can be met through daily monitoring of work conditions by the production leader, and workers wearing special clothing provided by the company.

Moreover, those who work temporarily with these devices should also be monitored and provided with adequate guidance. The supervisors should be adequately trained to ensure working conditions are suitable and controlled. This can be done with the help of a contractor guide developed for each work station listing the specific requirements of that station. Moreover, supervisors and managers must issue a work permit (ensures control of temporary workers) for personnel who interact with these devices on a temporary basis.

The whole process of sterilization is in vain if there is contamination during the post-sterilization processes. Therefore, manufacturing and supplying companies must document requirements for control of contamination with microorganisms and particulate substances in the work environment, along with maintaining the mandatory cleanliness throughout the assembly and packaging processes after sterilization. This can be managed with the help of proper ventilation systems, for example, dust collectors, and monitored through air quality tests (based on frequency) on processes after sterilization. Moreover, engineering controls should be in place for containment of sources resulting in contamination.

Requirements for work environment and cleanliness of devices ensures patients’ safety

Requirements of ISO 13485:2016 for work environment and cleanliness in organizations who produce or sell medical devices ensure patients’ safety. Separate lists, with justifications for each category of devices, make the organizational knowledge strong and unambiguous on cleaning requirements for each and every product. Requirements for work environmental and contamination controls help the organization to prevent contamination of the product. Therefore, all these requirements basically make the medical device manufacturing, marketing, and supplying processes efficient and safe.

ISO 13485:2016 is making the medical sector safe for all businesses within the supply chain and, ultimately, for the end consumer, i.e., the patient. So, with all these additional requirements, organizations can prove their excellence in the eyes of customers and prove that they really care for patients’ safety.

Use this free Diagram of ISO 13485:2016 Implementation Process to learn where managing cleanliness and contamination control fits into the ISO 13485 implementation.