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Has anyone got a good rationale, a decision tree or a list of questions that could be used to help DnD engineers to decide if a medical device shall be supplied sterile or not ?
I'm aware of the Spaulding classification, but it's more applied for retreating/reuse of MD.
Here the point is, as a manufacturer how could we decide that a MD shall be sterilized or not ?
lots of factors play an essential role : impact of the method of sterilization (discoloration, temperature,...) impact of the manufacturing flow (environment or not), compatbility of materials…
For example, a gastroscope should be disinfected before being used on a patient. But shall a single used device used in the digestive tract be sterile ? it will be in contact with food and so on… so, physicians say, give it non sterile… the point is, is there any constructive justification of this ? how could I incorporate such rationale in a technical file ? in a sterilization procedure (let's say "choose of sterilization" procedure) that would be defended in a microbiological audit ?
I'm sure I'm clear,
any idea/info is welcome,
thanks !
I'm aware of the Spaulding classification, but it's more applied for retreating/reuse of MD.
Here the point is, as a manufacturer how could we decide that a MD shall be sterilized or not ?
lots of factors play an essential role : impact of the method of sterilization (discoloration, temperature,...) impact of the manufacturing flow (environment or not), compatbility of materials…
For example, a gastroscope should be disinfected before being used on a patient. But shall a single used device used in the digestive tract be sterile ? it will be in contact with food and so on… so, physicians say, give it non sterile… the point is, is there any constructive justification of this ? how could I incorporate such rationale in a technical file ? in a sterilization procedure (let's say "choose of sterilization" procedure) that would be defended in a microbiological audit ?
I'm sure I'm clear,
any idea/info is welcome,
thanks !