MDA-Approved Surgical Instruments for Nail Avulsion
Standard surgical instruments for nail avulsion procedures include a nail elevator (spatula or Freer septum elevator), hemostat clamp, and surgical scissors or scalpel—these are basic surgical instruments that do not require specific MDA approval as they fall under general surgical instrument classifications.
Essential Instrument Set Components
Core Instruments
- Nail elevator device (spatula-type or Freer septum elevator) for separating the nail plate from the nail bed 1
- Hemostat clamp for grasping and removing the elevated nail plate 1
- Combination instruments that integrate both nail elevator and hemostat functions into a single device, reducing procedural steps and sterilization costs 1
- Surgical scissors or scalpel for wedge resection procedures when indicated 2
Procedural Context
The specific instruments needed depend on the clinical indication:
For ingrown toenails (onychocryptosis):
- Partial nail removal requires nail elevator, hemostat, and potentially scoop shave instruments for granulation tissue removal 3, 4
- Wedge resection (Winograd procedure) maintains better cosmetic outcomes compared to complete nail plate avulsion 2
For fungal infections with dermatophytomas:
- Mechanical removal instruments are necessary when dense white lesions beneath the nail prevent antifungal drug penetration 5, 4
- However, surgical avulsion followed by topical antifungals for routine onychomycosis is NOT recommended based on disappointing RCT results 3, 5
For drug-induced nail toxicities in cancer patients:
- Conservative measures (antiseptic soaks, topical steroids, taping, splinting) should be exhausted before nail removal 3, 4
- Scoop shave removal with hyfrecation is preferred for granulation tissue, not complete nail removal 3, 4
Infection Control Requirements
All instruments must meet standard surgical sterilization protocols:
- Reusable instruments require washing and sterilization between patients 3
- Single-use disposable alternatives eliminate sterilization costs and handling 1
- Surgical hand antisepsis with antimicrobial soap or alcohol-based surgical hand-scrub before donning sterile gloves 3
Important Caveats
- No specialized "MDA approval" exists for basic surgical instruments like elevators and hemostats—these are classified as general surgical instruments 1, 6
- Diabetic patients require vascular assessment before any nail removal procedure due to higher complication risk 5, 7
- Complete nail avulsion should not be routine treatment for fungal infections given poor evidence 3, 5, 4
- Combination instruments (elevator-hemostat hybrids) may reduce trauma to nail bed and matrix during avulsion 1