The FDA MAUDE database includes thousands of patient injury reports associated with broken, 扭曲的, 穿孔, 或者其他损坏的医疗设备. There are hundreds of articles in the clinical literature on broken surgical instruments alone. 为什么这些设备会失败? Was it a manufacturing or assembly defect? 会不会是用户错误? Was device integrity affected by cleaning agents? An engineering-based medical device failure analysis can delineate these possibilities. This is especially important in injury forensics to determine causation.
Investigations of medical device failures should be comprehensive and involve a 系统的方法, including cognitive interviews of those involved in the use and maintenance of the device, 事件仿真, and review of pertinent medical records.
Investigations should also incorporate 工程设备故障分析. Failure analyses include gross and microscopic device inspections as well as advanced techniques, 如:
- Thermal analysis to verify melting temperature, crystallization enthalpy and oxidative induction time.
- Elemental analysis of polymers, metals, ceramics and composites.
- High-resolution metallography and surface morphology to examine failure surfaces.
- Spectroscopy to determine molecular structure of polymers.
Advanced material analysis is also indicated for the identification of unknown materials. Unintended retention of foreign objects (URFO) is the second most reported sentinel event to The Joint Commission. 导丝片, 程序上的支架, 下水道, 套管针破碎的碎片, metallic shavings from laparoscopic instruments, 还有很多其他设备, instruments or fragments can be left behind following a procedure.
In some cases, a foreign body can be identified by context clues (e.g., a sponge left behind from an open surgery). But even in these cases, it may not be clear when the object was left behind (e.g., which surgery resulted in the misadventure). 除了, any contaminant found in the sterile environment on an instrument, in an instrument tray or in the surgical field can be identified using the techniques described herein. Including possible exemplar materials when identifying contaminants is very helpful.
We recommend that healthcare facilities and providers integrate material identification and medical device failure analysis into the regular investigative workflow of 医疗器械取证. 这包括:
- Developing procedures for proper evidence collection and sequestering of broken or damaged medical devices.
- Developing procedures for gross and microscopic inspection of devices.
- Dedicating a light microscope with photogrammetry capability for microscopic inspection.
- Identifying laboratory capability for advanced failure and material analysis.
- 涉及到冶金学家, 工业化学家, or appropriate materials scientist to interpret findings from advanced analysis.
- Establishing policies for handling damaged instruments and devices with the manufacturer and patient, which will vary depending on the type of device and whether a patient implant is affected.
- Involving facility risk management and legal counsel in the development of these policies.
Jensen Hughes is proud to support all areas of healthcare in the pursuit of high reliability and zero harm. 进一步了解彩宝网平台的 biomechanics forensic injury investigation services.