TDICT: Performance Standard

for the design, evaluation, and selection of medical devices

This Performance Standard was developed by the TDICT Project, in conjunction with line healthcare workers and the HIV Office of the Centers for Disease Control. It steps back from device specific criteria to look at overall procedures and the fundamental standards which must be met by all products, in all phases of use. Download a pdf version of this document.

Performance Standard vs. Selection Criteria

Generalized/ Generic	Device Specific Applications
Based on Procedure	Based on Device
Encompasses Product Life Cycle	Point of Use Only

MAJOR CATEGORIES

I. PATIENT SAFETY & QUALITY OF CARE

Is the proposed solution of equal or greater effectiveness?
Will the device improve patient well-being? (Quality Assurance)
Does the device increase time needed for given procedure?
Is the device FDA approved? Is it Class I, II, or III?
Does the device expose the patient to harmful elements? (Latex, X-rays, Chemicals, Extreme Light or Heat, etc.)
Does proper use of the device involve unnecessary invasions into the patient's body?

II. USER SAFETY

Does use of the device require excessive re-training?
Can most of the re-training be done in a lab or simulated setting?
Do new users experience a steep learning curve?
Does the level of expertise of the user affect the learning curve? (Novice vs. Expert user?)
Does the use of the device change the existing procedure significantly?
Is the device intrinsically more simple, as opposed to more complex, than the device it will replace?
Does the device require an action which is counter to prevailing procedures? (Is the correct use of the device intuitive?)
Does the device increase time needed for the given procedure?
Is the product self-contained as opposed to an assembly of different parts?
Does the product need to be disassembled-assembled prior to disposal?
Does the device fit well in the hand of the user as opposed to being cumbersome?
Who uses the given product?
Where and how will failure occur?
Can product be easily misused, used differently, co-opted for alternate use?
What are the scenarios for common, uncommon, and inappropriate use?
If a safety feature exists on the device, is it passively activated? (Effective without user interaction/interference)
Are the safety cues for the safety feature evident at all times? (Are clicks audible, visual markings noticeable, tactile sensations noticeable through gloves?)

III. USER FIT AND SATISFACTION

Will use of the device require excessive re-training?
Can most of the re-training be done in a "lab" setting?
Do new users experience a steep learning curve?
Does the level of expertise of the user affect the learning curve? (Novice vs. Expert user?)
Does the use of the device change the existing procedure significantly?
Is the device intrinsically more simple as opposed to complex?
Does the device require an action which is counter to prevailing procedures? (Is the correct use of the device intuitive?)
Does the device increase time needed for given procedure?
Is product self-contained as opposed to an assembly of different parts?
Does product need to be disassembled-assembled prior to disposal?
Does the device fit well in the hand of the user as opposed to being cumbersome?
Is the packaging of the device easy to open?
Does the packaging clearly indicate its contents?
Does the packaging clearly indicate the correct procedures for use of the device?
Are recycling or disposal directions clear on the packaging or product?
Where and how will failure occur?
Can product be easily misused, used differently, co-opted for alternate use?
What are the scenarios for common, uncommon, and inappropriate use?

IV. PATIENT FIT AND SATISFACTION

Will the device improve patient well-being? (Quality Assurance)
Is the proposed solution of equal or greater effectiveness?
Does the device increase time needed for given procedure?
Does the device expose the patient to harmful elements? (Latex, X-rays, Chemicals, Extreme Light or Heat, etc.)
Does proper use of the device involve unnecessary invasions into the patient's body?

V. PRODUCT LIFE-CYCLE

What environmental factors must be considered in product evaluation?
What is the product life-cycle?
Are recycling or disposal directions clear on the packaging or product?
Is product self-contained as opposed to an assembly of different parts?
Is the packaging excessive or cumbersome?
Does the device, or its packaging, present any new storage problems?
Does the device incorporate materials that are non-recyclable in places where recyclable materials would be just as effective?

VI. ADMINISTRATIVE FIT AND SATISFACTION

Does the cost of the product correlate closely with other similar devices on the market?
Is the cost prohibitive to widespread use of the product?
Does the cost of the product appear to be correlated to the expense of production?
Will implementation of the device require excessive re-training?
Can most of the re-training be done in a "lab" setting?
Does the level of expertise of the user affect the learning curve? Novice vs. Expert user?
Does the use of the device change the existing procedure significantly?
Is the proposed solution of equal or greater effectiveness?
Where is the product used?
What environmental factors must be considered in product evaluation?
What is the product life-cycle?
Are recycling or disposal directions clear on the packaging or product?
Does the device, or its packaging, present any new inventory problems?
Is the device FDA approved? Is it Class I, II, or III?
How does the device affect patient well-being? (Quality Assurance)
Who uses the given product?
Where and how will failure occur?
How might product be misused, used differently, co-opted for alternate use?
What are the scenarios for common, uncommon, and inappropriate use?
Does the device offer a distinct advantage to the institution using it?