Anytime a new product comes onto the market that you want to try out in the OR or in clinic, it has to be approved by UCI based on cost and safety.
The way to do that is listed below:
Administration Tools>Operational>Lumere (GHX Solution)
From here, you'll log in, then:
Submit a new product request
Enter all necessary details
There is an attached word doc below. I recommend sending it to the device company rep and making them fill it out for you. That way you can just copy paste it.
Submit
Await approval/signature from department (Dr. Lu or Dr Kuppermann)
Trial time is usually 60 days from approval to use the product.
You can ask/request more time. I have recently had reps do the corresponding with the coordinating people
Initial review with the big wigs, then you'll get invited to a monthly meeting to justify its use and why we need it/what in our supply doesn't cover it (usually can say it'll improve patient safety/outcomes with the new instrument and that works). Then approval or non-approval, or extension of trial time.
Basic info
What product are you looking for?
Product name or catalog number:
Manufacturer:
This product request is for:
Trial Use
Please provide details on how this product will be trialed:
Has a case requiring this product already been scheduled?
No
(For trial) How long will it take to complete the number of procedures necessary for this trial (e.g., two weeks versus three months)?
3-5 cases per surgeon
(For trial) What is the number of procedures necessary to complete the evaluation of the product?
3-5 cases per surgeon
(For trial) Which physicians should be included in this trial?:
Dr. Kapil Mishra, Dr. Riazi, Dr. Browne, Dr. Mehta, Dr. Lu, fellows: Dr. Masumi Asahi and Dr. Terry Hsieh
Will sterilization be required?
Will this product be used for inpatient, outpatient or both?:
Outpatient
What configuration or models are needed? If you have price quotes, please attached to supplemental documents section.
Outcomes
What are the desired outcomes of this product?
Why is this product necessary? (Please describe the clinical rationale behind this product request. If any specific features are needed. Include those here:
Which options best describe the expected clinical outcomes of using this product? This should be a measurable clinical outcome to support product adoption.
Decreased likelihood of additional procedures or complications
Decreased procedure time
Improved patient safety
Improved patient outcome
Describe how this product will contribute to UC Irvine’s mission:
Are there any other reasons we should consider this product?:
Procedures
For which procedure(s) will you use this product?:
Pars Plana Vitrectomy
What is the estimated annual procedure volume? 500
How many units are needed per procedure?:
Code type: CPT
Code: 67036
Impacted products
What products are your currently using?
Are there any products you are currently using to fulfill this clinical need:
What is the name of the product you are currently using?:
What is the model or item description for this product?:
What is the item number?
What is the catalog number?
Will the requested product completely replace or be used in addition to the current product?:
Product detail
Can you tell us more about the product you are requesting?
Do you have contact information for the device representative?
Entered from your email signature
What additional equipment is needed, if any?
N/A
Will physician credentialing be needed if this product is adopted?
N/A
Will staff training be needed if this product is adopted?
Stakeholders
Here’s who will be notified of this request. Is there anyone else who should be aware?
Supporting materials: Would you like to provide any files to support your request?
Please send a copy of the product page/reference page
Submit