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Release of sterile medical devices

In the circle of #MedicalDevicesReprocessing, the release is an essential step. Like in any production process, in the release stage, the criteria that allows declaring a device as "approved" for subsequent circulation and use must be established and measured.

In the case of #sterilization, this condition cannot be measured or determined directly on the #MedicalDevices, since they are protected by a physical barrier (packaging) that allows to maintain sterility till the point of use. Therefore, #sterilization cannot be measured directly on #MedicalDevices in routine practice.

The above does not mean that #sterility is an assumption. Indeed, it is not, and it cannot be. Simply because if it were an assumption, then having a surgery would be similar to playing Russian roulette.

#Sterilization is well defined and agreed in various standards as a validated process to kill viable microorganisms. Because microorganisms do not die at the same time in a process, sterility is defined as a probability (not an assumption) that is also measurable. There is also international consensus that #MedicalDevices can be declared sterile when they have undergone a validated process with a Sterility Assurance Level (#SAL) equal to or less than 10-6. Only then it’s possible to release #MedicalDevices as sterile in a documented way for further distribution and use.

It is not possible to determine at the point of use (e.g. in operating rooms) whether #MedicalDevices are sterile. Not even with the visual evaluation of a chemical indicator placed inside the sterile barrier. No indicator can tell that the #MedicalDevices contained in the same sterile barrier are really sterile. None. Neither chemical indicators nor biological indicators can do this.

Consequently, the release of sterile #MedicalDevices is only possible to be carried out in a documented way in the #RUMED, and when the critical processes have been validated by measuring the conditions on all internal and external surfaces of MDs, establishing an adequate routine monitoring and the requirements that must be met to release the #MedicalDevices with its corresponding documentation and evidence.

About the author

Matías Pilasi is member of AKI since October 2019 as ambassador for Latin America. He is specialized in the field of Hospital Hygiene, Cleaning, Disinfection, Packing and Sterilization as well as Process Validation in the Reprocessing of Medical Devices.

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