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Supply Chain Management

INSTRUCTIONS AND PROCESS FOR A NEW EQUIPMENT/PRODUCT TRIALS

Trials are for the express purpose of testing product/equipment (items) for their performance, quality characteristics and suitability in the clinical setting to enhance or improve patient outcomes.  This testing period allows the clinical teams to evaluate the items to determine if it performs same, better or worse than existing products or validates the information obtained via benchmarking platforms, supplier information, evidence-based papers, etc… when an item is brand new, never been used before.

Note:  It should never be assumed that once an item is onsite for a trial, that the item has been authorized to stay past the end of the trial timeframe.   A trial has a start and stop date and is treated completely separate from a New Product Request.  

There may also be costs associated with a trial. The requesting department should be prepared to fund the cost of a trial and ensure the funding is budgeted and available prior to making the request. 

Forms are to be completed PRIOR to the start of any trial of product or device as determined and approved by the FDA 510(K) process.  A 510(K) also known as a Premarket notification is a submission process that medical device manufacturers utilize to obtain clearance from the FDA to market eligible product in the U.S.   Once a device is cleared, the FDA issues a clearance letter that provides approval for the manufacturer to market the device.   This approval is not stating the FDA has approved the device itself, but that the FDA has determined the device is equivalent to a similar device already in the market.

There are also Class Levels (risk levels) the FDA assigns to medical devices.

Low risk – (generally exempt from premarket notification) includes most Class I and select Class II devices

Medium risk – 510(K) cleared includes most Class II and select Class I

High risk – (premarket approval) includes Class III devices that sustain or support life, are implanted, or present a potentially unreasonable risk of illness or injury

Key Criteria to launch a trial:

  • Duration of the trial can be no longer than 90 days or a set number of procedures within that 90 day window. 
  • Trials are to be conducted at no charge. Free product is never charged to patients or their insurance.  In the event there is a cost, the department is responsible for the expense.
  • If there are Information Technology (IT) components (ie, network connectivity, EPIC integration, then the IT PMO (project management) process must be initiated and IT approval obtained before agreement can be executed.
  • An executed trial agreement and no charge PO must be in place prior to arrival of equipment.
  • Equipment must be checked in by biomedical engineering
  • Training/education must be coordinated with the clinical champion.

Process steps:

  1. Submission requests can be initiated by any clinical person within the various clinical departments/areas of UTMC.   A physician, nurse, clinical manager is required to champion each trial request.   The champion or their designee is responsible for tracking the usage of trialed items and collecting the data for evaluation upon completion of the trial.  Complete the Trial Request form found on the Supply Chain Management website under Value Analysis link for forms.
  2. Once the Trial Request form is completed online and submitted, it routes electronically to the Value Analysis team for review.   If the form is incomplete, it will be returned to the requestor for additional information.
  3. [FUTURE] A completed form request, once accepted by Value Analysis Project Manager (VAPM), will be placed on the next monthly Value Analysis agenda and the champion will be invited to the meeting to address the Value Analysis Committee (VAC) as to the request for trial and to answer any questions of the committee.    **Note:  Value Analysis meets on the 2nd Tuesday of each month.   Deadline for submission of new trial requests is 2 weeks prior to VAC meeting date (last Tuesday of the month). VAC members will discuss and render a decision as to the approval or denial of a trial request during the VAC meeting.
  4. The decision will be communicated back to the champion by the Value Analysis Facilitator within 24 hours of the VAC meeting.
  5. If trial is approved, the VAPM will schedule a meeting with the vendor, the champion and purchasing team (within the week) to understand the rules of the trial, determine if there will be any costs, the timeframe of the trial and any contractual paperwork needing completed prior to the start of the trial.   It should also be discussed with champion the method of data collection and at what date do they need to report back to VAPM with results of the trial.   Depending on the item, the champion may be asked back to VAC to share with the committee the results of the trial.   The VAPM will monitor all dates, follow up and communication.   
  6. If the trial was successful and the champion desires to now request the item be added to formulary or equipment to be purchased, there are separate procedures for New Product Requests and Requests for Capital Equipment.   All procurement rules will apply.

 

 

Last Updated: 4/21/25