Cause of Device-Related Incident
Device factors; Support system failures; User errors

Clinical Specialty or Hospital Department
Clinical/Biomedical Engineering; OR / Surgery

Device Factors
Device interaction

Document Type
Hazard Reports

External Factors
*Not stated

Mechanism of Injury or Death
Mechanical (puncture, perforate, lacerate, break, cut, tear, nick, crush)

Support System Failures
Poor prepurchase evaluation

Tampering and/or Sabotage
*Not stated

User Errors
Device misassembly; Failure to perform pre-use inspection

UMDNS
Dermatomes [11-179]; Knives, Dermatome [12-243]

Use of Incompatible Dermatomes and Blades



Hazard [Health Devices Apr 1994;23(4):145]

Problem

In preparation for harvesting skin for grafting, one brand of disposable dermatome blade was inserted into a different brand of dermatome. The disposable blade apparently fit well, although it had no marks identifying the manufacturer or the proper blade orientation. When the surgeon attempted to use the dermatome to shave off a thin patch of skin, it made deep lacerations. The blade was then turned over and used again with the same result. A blade that is of the same brand as the dermatome has a different shape than the incident blade and is designed so that it cannot be installed incorrectly, was then used, and the dermatome performed properly.

Discussion

ECRI's databases contain many reports of injury related to the assembly and use of various manufacturers' dermatomes. Dermatomes are precision surgical instruments and must be assembled, used, and maintained with care. Users should be thoroughly knowledgeable about these devices, including their operation, parts, and limitations. While some dermatomes are designed to prevent misassembly, the reported incident shows that incompatible parts, such as blades, can be interchanged between some manufacturers' dermatomes. Dermatome instruction manuals clearly warn against using non-brand-specific parts for this reason. Other dermatomes can be misassembled by users unfamiliar with the proper shape of a mating blade or the appearance of a correctly assembled device. Reading and understanding the instructions can prevent these kinds of problems.

Manufacturer action

In their respective instruction manuals and packaging, both manufacturers warn against using other manufacturers' blades in their dermatomes. To further warn users, the incident disposable blade manufacturer will be etching its name on all new blades. The dermatome manufactuer will imprint a warning on new dermatomes to use only its brand of blades. Both companies also advicate user education to prevent misuse of dermatomes and blades.

Recommendations

  1. Read and understand the assembly and use instructions before using any dermatome.
  2. Use only blades clearly specified for use in the dermatome. Do not mix one brand of blade with another brand of dermatome unless the manufacturers specifically state that these products are compatible.
  3. Ensure that the blade is properly assembled in the dermatome. Most manufacturers place labels or legends on the blade to indicate proper assembly.

UMDNS Terms

  • Dermatomes [11-179]
  • Knives, Dermatome [12-243]

Cause of Device-Related Incident

Device factor: Device interaction

User errors: Device misassembly; Failure to perform pre-use inspection

Support system failure: Poor prepurchase evaluation

Mechanism of Injury or Death

Mechanical (Lacerations)


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