Thanks for the very helpful explanations and examples. You mentioned the Sterilizant as hazard, but is this the hazard or is it the chemical residue in it? I sometimes struggle with such hehn-egg hazards (e.g. urinary tract infection after cathetherization, is the hazard the catheter, the microflora or the combination of both, but which could be also the hazardous situation), trying to find a structured and good approach to this. Maybe you have an advise, how to differentiate this?
Sterilant residue is typically a hazard, and the harm is typically a reaction to high concentrations of sterilant. There are three risk controls for the sterilant: 1) a design specification setting a maximum concentration of the EO/ECH residues, 2) a validated sterilization process specification establishing a minimum amount of time for degassing, and 3) a label that indicates that the product was sterilized via ethylene oxide using the symbol for EO sterilization. The ISO 10993-7 testing is your verification testing to confirm effectiveness of the risk controls. In your example where you mention the harm being a urinary tract infection (UTI), there are multiple possible reasons for the UTI. In this case, the best tool to identify the root cause and analyze the risk control is a fault-tree diagram. This is because we are starting with the harm instead of the failure mode (i.e., dFMEA). If we concentrate on a UTI being caused by inadequate sterilization of the catheter (not the most common cause), the hazard is a non-sterile catheter. The risk controls are: 1) a design specification for the sterilization process, 2) a validated process to ensure the sterilization process can eliminate all bioburden from the device, and 3) a label indicating the product should not be reused or infection (i.e., a UTI) may occur. Unfortunately, once a UTI occurs it is nearly impossible to determine if the infection was caused by hygiene in the hospital or a non-sterile catheter. There is always a hazardous situation, but in your example hazardous situations are only important if we are talking about use errors.
That's a great question. For people that are not familiar with the IMDRF codes Annex A, you can search Google or use this link: www.imdrf.org/working-groups/adverse-event-terminology/annex-medical-device-problem. These are generic codes for classification of device malfunctions or problems--not the hazards. Also, because they are generic, it should only be part of the information you provide in your PMS reports. Ideally, you would have device-specific hazards. Typically there are multiple hazards that can lead to the same device malfunction.
@@MedicalDeviceAcademy Thanks for your reply. I really appreciate that. Then probably we can link it to the hazardous situation resulting from one or more device specific hazards and then to complaint monitoring for PMS.
Fantastic!!
Thanks for the very helpful explanations and examples. You mentioned the Sterilizant as hazard, but is this the hazard or is it the chemical residue in it? I sometimes struggle with such hehn-egg hazards (e.g. urinary tract infection after cathetherization, is the hazard the catheter, the microflora or the combination of both, but which could be also the hazardous situation), trying to find a structured and good approach to this. Maybe you have an advise, how to differentiate this?
Sterilant residue is typically a hazard, and the harm is typically a reaction to high concentrations of sterilant. There are three risk controls for the sterilant: 1) a design specification setting a maximum concentration of the EO/ECH residues, 2) a validated sterilization process specification establishing a minimum amount of time for degassing, and 3) a label that indicates that the product was sterilized via ethylene oxide using the symbol for EO sterilization. The ISO 10993-7 testing is your verification testing to confirm effectiveness of the risk controls.
In your example where you mention the harm being a urinary tract infection (UTI), there are multiple possible reasons for the UTI. In this case, the best tool to identify the root cause and analyze the risk control is a fault-tree diagram. This is because we are starting with the harm instead of the failure mode (i.e., dFMEA). If we concentrate on a UTI being caused by inadequate sterilization of the catheter (not the most common cause), the hazard is a non-sterile catheter. The risk controls are: 1) a design specification for the sterilization process, 2) a validated process to ensure the sterilization process can eliminate all bioburden from the device, and 3) a label indicating the product should not be reused or infection (i.e., a UTI) may occur. Unfortunately, once a UTI occurs it is nearly impossible to determine if the infection was caused by hygiene in the hospital or a non-sterile catheter.
There is always a hazardous situation, but in your example hazardous situations are only important if we are talking about use errors.
Hi, Can we use IMDRF codes Annex A to identify hazards related to device malfunctions for the product already in post market phase?
That's a great question. For people that are not familiar with the IMDRF codes Annex A, you can search Google or use this link: www.imdrf.org/working-groups/adverse-event-terminology/annex-medical-device-problem.
These are generic codes for classification of device malfunctions or problems--not the hazards. Also, because they are generic, it should only be part of the information you provide in your PMS reports. Ideally, you would have device-specific hazards. Typically there are multiple hazards that can lead to the same device malfunction.
@@MedicalDeviceAcademy Thanks for your reply. I really appreciate that.
Then probably we can link it to the hazardous situation resulting from one or more device specific hazards and then to complaint monitoring for PMS.