Health Care Technical Group

Hello There,

I'm designing a human factors simulated-use reprocessing validation study to demonstrate that a reusable surgical device can be reprocessed (cleaned and sterilized) following the reprocessing instructions.

In real-world use the sponsor will provide training to sterilization technicians, however, since all technicians may not be able to attend the training sessions, training is not guaranteed and will not be provided to study participants. 

The worst-case situation is when a new sterilization technician needs to reprocess the device when they have not seen it before. 

Since a sterilization technician would normally be able to "Ask a colleague" if they had a question, I was going to provide that as an option in the study. 

Do you provide "Helpline" or "Ask a colleague" support in HF reprocessing validation studies? Is this acceptable to the FDA?

Thank you,
Sue

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sue lynch
Largs NSW
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Important question!. The more we can do in validation studies to represent use in the real world, the better.

"A large hospital can have 250 000 unique instruments, so it is unlikely that even the most experienced and highly trained SPD technician will be familiar with decontamination for every single instrument. Observation of a 20 min 'in-service' update focusing on two instruments from one equipment manufacturer suggested incongruency of training with the working environment and production pressure." - Alfred et al. Work systems analysis of sterile processing: decontamination

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Ken Catchpole, , PhD, BSc, C.ErgHF, MCIEHF
Endowed Chair in Clinical Practice and Human Factors
Medical University of South Carolina
Charleston SC
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Original Message:
Sent: 05-26-2023 02:51
From: sue lynch
Subject: HF simulated-use reprocessing validation study

Hello There,

I'm designing a human factors simulated-use reprocessing validation study to demonstrate that a reusable surgical device can be reprocessed (cleaned and sterilized) following the reprocessing instructions.

In real-world use the sponsor will provide training to sterilization technicians, however, since all technicians may not be able to attend the training sessions, training is not guaranteed and will not be provided to study participants. 

The worst-case situation is when a new sterilization technician needs to reprocess the device when they have not seen it before. 

Since a sterilization technician would normally be able to "Ask a colleague" if they had a question, I was going to provide that as an option in the study. 

Do you provide "Helpline" or "Ask a colleague" support in HF reprocessing validation studies? Is this acceptable to the FDA?

Thank you,
Sue

------------------------------
sue lynch
Largs NSW
------------------------------

Hi Ken,

Thank you for replying to my message and the link (Alfred et al) I really appreciate it and I discovered the other recent related studies. They are super helpful and provide a lot of clarity and detail about the work environment and challenges in this area. Congratulations to you and the co-authors on these studies. 

Based on this research I'm left wondering whether it's realistic to think that participants will pass the/any human factors reprocessing validation study. A few pilots will be required.

I think I'll design the study so that a "Helpline" or "Ask a colleague" is available only if requested by the participant if this would be available in actual use. Scripting this has some challenges as I want to provide minimal information. There is not a lot of best-practice information available about how to provide "Helpline" or "Ask a colleague" support in a validation study which does make it open to criticism.

Thank you again for your help.

Kind regards,
Sue

Work systems analysis of sterile processing: decontamination

Work systems analysis of sterile processing: assembly

A Work Systems Analysis of Sterile Processing: Sterilization and Case Cart Preparation

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Sue Lynch
Product Development and Human Factors Specialist. BID. RN.
MedTech Pathways. North Sydney. Australia
Good Design Ambassador

------------------------------

Original Message:
Sent: 05-27-2023 10:21
From: Ken Catchpole
Subject: HF simulated-use reprocessing validation study

Important question!. The more we can do in validation studies to represent use in the real world, the better.

"A large hospital can have 250 000 unique instruments, so it is unlikely that even the most experienced and highly trained SPD technician will be familiar with decontamination for every single instrument. Observation of a 20 min 'in-service' update focusing on two instruments from one equipment manufacturer suggested incongruency of training with the working environment and production pressure." - Alfred et al. Work systems analysis of sterile processing: decontamination

------------------------------
Ken Catchpole, , PhD, BSc, C.ErgHF, MCIEHF
Endowed Chair in Clinical Practice and Human Factors
Medical University of South Carolina
Charleston SC

Original Message:
Sent: 05-26-2023 02:51
From: sue lynch
Subject: HF simulated-use reprocessing validation study

Hello There,

I'm designing a human factors simulated-use reprocessing validation study to demonstrate that a reusable surgical device can be reprocessed (cleaned and sterilized) following the reprocessing instructions.

In real-world use the sponsor will provide training to sterilization technicians, however, since all technicians may not be able to attend the training sessions, training is not guaranteed and will not be provided to study participants. 

The worst-case situation is when a new sterilization technician needs to reprocess the device when they have not seen it before. 

Since a sterilization technician would normally be able to "Ask a colleague" if they had a question, I was going to provide that as an option in the study. 

Do you provide "Helpline" or "Ask a colleague" support in HF reprocessing validation studies? Is this acceptable to the FDA?

Thank you,
Sue

------------------------------
sue lynch
Largs NSW
------------------------------