What is ISO 13485 sterilization requirement? One of the must-haves for medical device industries is to have an established set up for sterilization of medical devices being used. Improper sterilization can become life-threatening for patients as it may result in germs transfer. Various infections after surgery can be infected in patients due to improper sterilization practice for medical devices.

Medical devices can be described as an instrument, apparatus, machine or an implant that is intended to be used in diagnosis, prevention or treatment of any disease or to be used in any other medical condition as prescribed by the physician.

Definition of ISO 13485 Sterilization requirements

Sterilization requirement is one of the necessary processes that should be practiced in medical device industries, and it is done for the purpose of making medical devices free from bacteria, and other micro-organisms that cannot be removed by conventional cleaning practices and so the sterilization requirements have been mentioned and elaborated separately in ISO 13485:2016.

During numerous surgeries, many medical devices and surgical instruments are often reused on more than one patients. To cease the transfer of bacteria from one person to another person, it is essential to sterilize the surgical instruments after they are used in any surgery to avoid contamination by micro-organisms. Numerous methods are being used to sterilize medical surgical instruments, which includes:

  • Autoclaving radiation
  • Ethylene Oxide (ETO) Sterilization
  • Chlorine Dioxide Sterilization
  • Hydrogen Peroxide Sterilization
  • And other ways.

Is it Necessary to Sterilize Surgical Instruments?

As ISO 13485 Sterilization requirements emphasizes, it is important to ensure safe medical conditions for patients during any surgery (Major or Minor one). The whole purpose is to eliminate any possible chances of surgery-induced diseases and other related medical issues.

To ensure a patient’s safety during any medical surgery, these previously stated problems are significant to eliminate. To answer why to sterilize the surgical medical devices, here is an answer:

  1. The process of sterilization ceases the bacterial growth on surgical medical devices instruments, and by then, the bacterial transfer chances stop.
  2. Some lethal diseases like HIV that can spread from one patient to another patient eventually stops.
  3. The sterilization process prevents any real chances for a bacterial infection that may require more surgeries.

How to Follow ISO 13485  to Comply with Sterilization Requirements

The requirements for sterilization has been widely spread in whole ISO 13485:2016 standard. The few clauses that state the requirements of sterilization are:

  1. Clause 3.20: Sterile Medical Device

Sterility requirements for all medical surgical instruments and devices have been mentioned in the requirements of regulatory authorities. These regulatory authorities can be anyone using products or services of your business, so one need to ensure that you are providing up to the mark services and products.

  1. Clause 6.4.2: Contamination Control

ISO 13485 ,6.4.2 clause clearly states the prevention of contamination after the devices are sterilized. This is done with the help of engineering controls like dust collectors and ventilation systems by monitoring air quality at a frequency being already defined and can be recorded before and after sterilization.

  1. Clause 7.5.5: Particular Requirements for Sterile Medical Devices

The clause 7.5.5 states requirements in the form of two sets, which are:

  • All the records of sterilization process parameters of every batch have to maintained and recorded. The sterilization process parameters can include various parameters to be registered like temperature, pressure, gas flow, humidity level, environmental conditions or even the name of the operator because the human factor is also one of the vital elements that can affect the quality of the sterilization.
  • Every batch of sterilization needs to be traceable, which means getting back the information where it was packed, shipped with complete sterilization records.
  1. Clause 7.5.7: Sterilization Process Validation and Sterile Barrier Systems

The clause 7.5.7 declares two sets of requirements, which are:

  • Sterilization Processes’ Validation: It’s not sufficient to only carry on the sterilization process. It is equally important to validate the method of sterilization. The review of the validation process will further highlight any need to change the process or product.
  • Sterile Barrier System’s Validation: There is one of the mandatory requirement to install a Sterile Barrier System that should have the maximum sufficient ability to not only barricade but to protect medical devices that are being sterilized should be ceased to again being contaminated from micro-organisms. A sterile barrier can be engineered in a control room containing bio-sensors for medical devices’ packaging with appropriate sensors and alarms indicating any signs of bio-contamination and should be able to cease any cross-contamination about to happen but such Sterile barrier systems need to be also validated in case an amendment is required for the design change, or any parameter control has to be changed.

Benefits of Implementing Rock Solid Sterilization Process

All the clauses of ISO 13485 have numerous benefits of implementing and deeply involved in the life cycle of medical devices:

  1. Sterilization Strengthens Customers’ Trust

Those medical devices that are being sterilized ensure the prevention of many health risks. Compromised medical equipment can result in fatalities, specifically when it comes to micro-organisms that can badly infect the human body.

  1. Easy Traceability

In case of any non-conformity that occurred in the system can be corrected right away if the sterilization process contains documented records of every step hence making the whole correction process easy due to concrete trace ability of sterilization process. In case a non-conformity comes into observation during the production process, the immediate action to be taken is to stop the production process until complete investigation.

  1. Management of Risks

By reliable traceability, the medical device industry can effectively manage the risks and can demonstrate the compliance to the highest level possible fulfilling all the legal and regulatory requirements of the country.

  1. Competitive Advantage of ISO 13485 Sterilization

The medical devices’ industry that is being able to fulfill each requirement of ISO 13485 standard, including the needs of regulatory authorities.

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