What are there ISO 13485 Contamination Guidelines? Imagine being operated on with inadequately sterilized surgical tools. Seems dangerous!  During treatment of some diseases, medical devices come in contact with humans. They need to be 100% sterilized, clean and free from germs. Bacteria and germs that can spread from one patient to another and result in various infections and life-threatening diseases.

QMS (Quality Management System) and ISO 13485 Contamination Guideliness specifically for medical devices’ industries will help meet the requirements that ensure patients’ safety.

ISO 13485 is a standard that best describes the requirement of a QMS that provides wholesome requirements for medical devices’ industries and puts an increased focus on thinking based on a risk-based approach that brings closer organizations to compliance.

The idea of the product life cycle and and risk-based approach should have a purpose to minimize harm which is associated with the safety and performance of medical devices.

To eliminate such health hazards, ISO 13485 has made sterilization a necessary process for every medical device. Many medical industries get confused between cleaning and sterilization and tend to use the terms interchangeably. There is a big difference between the methods.

Difference between Sterilization and Cleanliness

Sterilization is the process in which biological contamination or biological agents are being removed by decontamination, whereas cleanliness is defined as the activity of removal of impurities present at micro level from a medical device.

ISO 13485 Contamination Guidelines Requirements for Contamination Controls

There are a set of requirements in ISO 13485 in clause 6.4.4 named Contamination Control. The intent is for controlling contamination in medical devices to prevent health hazards.

Controlled work conditions are required by identifying and documenting the work environment. This is essential so that cross-contamination cannot occur. This includes a contaminant waste area, appropriate equipment like dust collector systems. These procedures must be under strict monitoring. Medical devices’ industries must identify any health hazards and requirements of their cleaning and clothing (if any).

Production leaders are advised to closely monitor working conditions and verify if workers are wearing special medical clothing or uniforms provided by the pharmaceutical industry. As far as temporary contractual workers are concerned, their health conditions should be checked periodically, and they should be trained and guided sufficiently so that they can perform their assigned task efficiently.

Before training workers, educate their supervisors with proper post training evaluation. Ensure that the manager and safety personnel have approved the work permit.

Please be aware of the fact that there is no use of sterilization if contamination happens right after the sterilization process. Control of contamination from micro-organisms and substances that are particulate and exist in a working environment must be documented so that the requirement of ISO 13485 contamination control can be satisfied.

For maintaining contamination control environment, it is must to have some special equipment to maintain the same like dust collectors, any particular device that can provide accurate count of particulates in air, any device that can give precise air quality number in working conditions or any engineering or administrative control should be in placed to eliminate sources of contamination present in the working environment.

Following types of documentation are mandatory to satisfy the requirements of ISO 13485 contamination control, which are:
  • Good Hygiene Practices
  • Defined and followed cleaning frequencies of manufacturing plant cleaning
  • Maintenance of air vents
  • Procedure for personal clothing

Handling Contaminated / Potentially Contaminated Products

All the activities should be documented while managing contaminated products including receiving, accepting, cleaning, segregating and decontaminated processes along with material, spare parts, attached parts, products or finished products that are defected or detected with potential non-conformities should be separated and controlled until complete rework, repair or disposal.

Contamination Control for Sterile Medical Devices

Here is how contamination control can be done in accordance with ISO 13485:

  • Designed and Documented activities for contamination control for micro-organisms or particulate materials.
  • Defined roles, responsibilities and authorities
  • Close monitoring and precise measurements of the sterile environment
  • Preventive actions strategies
  • Equipment Specifications
  • Verification and Validation
  • A sterile work environment with checks
  • Control change management

Cleanliness Requirements by ISO 13485

Cleanliness requirements during the assembly and packaging process have also been addressed in ISO 13485. Below enlisted are summarized requirements Cleanliness as mentioned in ISO 13485:

  1. An updated list of devices that are used in medical devices’ industries before use or sterilization as medical devices need cleaning before the sterilization process.
  2. Not all medical devices can be cleaned before sterilization, and those few devices also need to be enlisted and thoroughly documented.
  3. Enlist all medical devices that are delivered in non-sterile condition and need to be cleaned before use or sterilization. Documentation should be there with contamination control requirements.
  4. Enlisted medical devices that should always be cleaned before use but come in non-sterile condition.
  5. All process agents must be enlisted from products during manufacturing processes with contamination control for every process agents.

How ISO 13485 Ensures Patients’ Safety?

ISO 13485 Contamination Guidelines help all the medical devices’ manufacturers and sellers to ensure patients’ safety at all cost. Each medical device has to be categorized with separate lists that will surely enable the organizations to manage operations efficiently and effectively and cleaning requirements for every product.