EVD Product Evaluation: Running a 60-Day Pilot With a Hospital
How to plan and run a 60-day EVD product evaluation in one hospital unit: scope, training, feedback forms, issue logging and a report the committee can use.
Key Takeaways
- A 60-day EVD evaluation tests usability, workflow and support in one unit; it is not a clinical outcome study.
- Success criteria, training on every shift and a simple feedback form must be agreed before the first drain.
- Every product issue during the pilot is logged and reported to the manufacturer, not just discussed.
- The final report goes back to the value analysis committee with facts, not impressions.
A 60-day EVD product evaluation puts a new drainage system into one unit, usually the neuro-ICU, with trained staff, agreed success criteria and a simple way to record feedback and issues. At the end, the hospital has real user experience to bring to its value analysis committee. The pilot tests usability, workflow and support, not patient outcomes.
What is a 60-day evaluation, and what is it not?
A product evaluation is a structured trial of a device in routine use, run under the hospital's own policies. Its purpose is to answer practical questions. Can nurses set up and level the system confidently? Do surgeons find the catheter and kit components straightforward? Does supply arrive on time? Are questions answered quickly?
It is not a clinical study. Sixty days in one unit will include a limited number of drains, and nobody should draw conclusions about infection rates or other outcomes from that experience. If the hospital wants to study outcomes formally, that is a separate project with its own oversight. Keeping the evaluation honest about its scope protects everyone, including the manufacturer and the distributor.
Sixty days is long enough for most units to place several drains, rotate staff through day, night and weekend shifts, and see at least one full cycle of restocking. It is short enough to keep attention and momentum.
What has to be agreed before day one?
Most failed evaluations fail before they start, because the scope was vague or the training was incomplete. Before the first system is opened, the champion, nursing education, supply chain and the distributor should agree in writing on:
- the unit or units included, and whether the OR and emergency department are in scope;
- which products are being evaluated, for example the EVD-010 Series alone, or also the EVD-020 Series with the lumbar drainage catheter kit for lumbar drains;
- whether standard catheters, antibiotic-impregnated catheters or both are included, following the hospital's own protocol;
- how many units of evaluation stock will be supplied, where they will be stored and how they are labeled so they are not confused with the current system;
- the success criteria and the feedback form;
- who logs and reports product issues, and how quickly the manufacturer responds;
- the end date and the date the results go to the committee.
How should training be organized?
EVD is managed by nurses on every shift, so training has to reach every shift. A single daytime in-service misses the people who will manage the first drain at three in the morning.
A workable plan includes short in-services at shift change for day, night and weekend staff; a super-user on each shift who has extra hands-on time with the system; a one-page quick reference kept in the unit; and a session for residents and advanced practice providers who place drains. The distributor's rep should be reachable by phone during the first two weeks and on site for the first placements where the hospital allows it.
Training should cover the steps that generate most questions: assembling and mounting the system, leveling the reference point, reading the 30 cm measuring scale on EVD-010, setting the drip chamber to the ordered height, clamping for transport and repositioning, emptying the 150 ml drip chamber into the 800 ml drainage bag, and changing the bag while keeping the system closed. Nurses should also learn to recognize the orange antibiotic-impregnated catheter.
Supporting the people who place drains
Residents and advanced practice providers often place drains in the emergency department or at the bedside, sometimes under time pressure. Before the pilot, walk them through the kit contents, the catheter and how it connects to the drainage system, so that nothing is unfamiliar during an urgent placement. Many departments find a short session at a resident conference works well, followed by a laminated kit diagram stored with the evaluation stock. Ask the senior resident to tell new rotators about the pilot as they arrive.
What does a week-by-week plan look like?
| Period | Focus | Output |
|---|---|---|
| Before start | Agreement, stock delivery, training on all shifts | Signed scope, training log |
| Weeks 1–2 | First placements with support available | Feedback forms, questions log |
| Weeks 3–6 | Routine use, super-users answer most questions | Ongoing feedback, issue log |
| Weeks 7–8 | Wrap-up, staff survey, supply review | Draft report |
| After end | Committee review | Final report and decision |
A short check-in every two weeks between the champion, the nurse educator and the distributor keeps the evaluation on track. Problems raised early can be solved; problems raised at the end become reasons to say no.
What should be measured?
Measure what the evaluation can actually show. Useful measures include:
- user ratings after each placement and each shift managing a drain, on a few specific items: setup, leveling, readability of the scale, drip chamber handling, bag emptying and change, clamping;
- open comments from nurses, surgeons and residents;
- the number of questions to the rep or super-users, and their themes;
- every product issue, described factually, with the lot number;
- supply performance: orders placed, delivered on time, any shortages;
- the time taken to train staff to a level where they feel confident.
Setting a fair baseline
Ratings mean little without a comparison. Before the pilot starts, ask the same staff to rate the current system on the same items, using the same form. At the end, the committee can see where the new system was rated better, the same or worse, by the same people. This also shows the champion which concerns existed before the pilot and were not caused by the new product.
Be careful with small numbers. If only a handful of drains are placed, present the ratings as counts and comments rather than percentages, which can look more precise than they are.
Keep the form short. A form with five questions and a comment box gets completed; a form with twenty gets ignored after the first week.
How should product issues be handled during the pilot?
Any issue with the device, however small, should be recorded with the date, the lot number, what happened and what the staff did. The distributor forwards it to the manufacturer the same day, and the manufacturer acknowledges and investigates it under its complaint handling procedure. DESU works under an ISO 13485 quality management system, which requires complaints to be documented and evaluated.
Handling issues openly during an evaluation builds trust. Hospitals know that no device is free of problems; what they want to see is how the manufacturer and the distributor respond when something happens.
What goes into the final report?
The final report should be short and factual. It summarizes the scope, the number of systems used, training completed, user ratings and themes from comments, any issues and how they were resolved, and supply performance. It ends with the champion's recommendation.
Avoid turning the report into a sales document. The committee will trust it more if it includes the criticisms along with the praise, and shows what was done about each one. If nurses asked for a different quick-reference layout or a change to the training, say so and show that it was addressed.
Talk to a DESU product specialist
If a hospital you work with is ready to evaluate a new drainage system, DESU's product specialists can help you plan the scope, provide training material and documentation, and discuss evaluation stock for your market. Write to sales@desu.tr or request a quote to start planning.
Frequently Asked Questions
Why 60 days for an EVD evaluation?
Sixty days usually allows several placements, exposes the system to every shift and includes at least one restocking cycle. It is long enough for staff to move past first impressions and short enough to keep attention. Units with low drain volume may need longer, which should be agreed at the start.
Can an EVD evaluation show whether infection rates change?
No. A short evaluation in one unit includes too few drains to support conclusions about infection or other outcomes, and many other factors influence them. The evaluation should focus on usability, workflow, training and supply. Outcome questions need a properly designed study with its own oversight.
Who should own the evaluation in the hospital?
A clinical champion, often a neuro-ICU nurse leader or a neurosurgeon, working with nursing education and supply chain. The distributor supports training and logistics, and the manufacturer supplies products, documentation and technical answers. Ownership by the hospital keeps the results credible for the committee.
How should evaluation stock be kept separate from the current system?
Store it in a clearly labeled location, tell staff where it is, and include it in the training. Agree how many units are supplied and how unused stock will be handled at the end. Recording lot numbers on receipt makes later traceability simple if an issue is reported.
Which DESU products are usually included in an evaluation?
Most evaluations start with the EVD-010 Series in the neuro-ICU, with standard or antibiotic-impregnated catheters according to protocol. Units that also manage lumbar drains may add the EVD-020 Series with the lumbar drainage catheter kit, so that one drainage system covers both routes.
Sources
- Fried HI et al. The Insertion and Management of External Ventricular Drains: An Evidence-Based Consensus Statement. Neurocritical Care, 2016
- AANN Clinical Practice Guideline Series: Care of the Patient Undergoing Intracranial Pressure Monitoring/External Ventricular Drainage or Lumbar Drainage. American Association of Neuroscience Nurses, 2011
- ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
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