Document Types

• Hazard Reports--A hazard is a possible source of peril, danger, or difficulty. ECRI publishes reports about medical device models in which we have identified a fault or design feature that might, under certain circumstances, place patients or users at risk.


• User Experience Network™ Reports--These reports describe common or nuisance problems that ECRI believes are unlikely to pose a significant hazard. Typically they can be corrected with an available modification or revised operating or maintenance procedures.


• Guidance Articles--These articles provide in-depth guidance on such healthcare technology and patient safety issues as preventing and responding to surgical fires and electromagnetic interference and medical devices.


• Frequently Asked Questions (FAQs)--Our member hospitals and other healthcare practitioners and providers turn to ECRI's medical device and health services experts for answers to their day-to-day challenges. Our responses, when deemed helpful to the medical community as a whole, have been published in various formats over the years.


• Posters and Checklists--As part of ECRI's continuing mission to educate users about the safe use of medical devices, we have published posters and checklists that summarize basic safety precautions for common devices (e.g., electrosurgical units) or procedures (e.g., emergency defibrillation) with inherent risks to patients and/or healthcare workers.

Cause of Device-Related Incident

Five broad causes are at the heart of all medical device failures and related injuries and deaths.

1. Device factors
2. External factors
3. Support system failures
4. Tampering and/or sabotage
5. User errors

Each of these causes are broken down into more specific categories:

• Design/labeling error
• Device failure
• Device interaction
• Failure of accessory
• Improper maintenance, testing, repair, or lack or failure of incoming inspection
• Improper modification
• Invalid device foundation
• Manufacturing error
• Packaging error
• Random component failure
• Software deficiency

• Electromagnetic or radio-frequency interference (EMI and RFI)
• Environment (temperature, humidity, light)
• Medical gas and vacuum supplies
• Power supply (including compressed medical gases)
• Water supply

• Error in hospital policy
• Failure to impound
• Failure to train and/or credential
• Improper storage
• Lack of competent accident investigation
• Lack or failure of incoming and pre-use inspections
• Poor incident/recall reporting systems
• Poor prepurchase evaluation
• Use of inappropriate devices

• Tampering

• Abuse of device
• Accidental misconnections
• Accidental spill
• Device misassembly
• Failure to perform pre-use inspection
• Failure to read label
• Improper connection
• Inappropriate reliance on an automated feature
• Incorrect clinical use
• Incorrect control settings
• Incorrect programming

Each case has been categorized by the clinical specialty affected by the reported hazard and/or the area of the hospital in which the incident occurred. We have also categorized some documents by other specialties/areas that use the implicated device and could benefit from reviewing ECRI recommendations on preventing or responding to the kind of incident described in the case.

ECRI’s Universal Medical Device Nomenclature System™ (UMDNS™ ) terms and codes can also be used to search the reports.

Within the text of each record, where appropriate, you will also find the mechanism of injury or death that occurred or could have occurred as a result of the incident. These include the following:

• Anaphylaxis
• Barotrauma
• Blindness
• Burn (electrical, thermal, chemical)
• Coagulopathy
• Electrical shock/electrocution
• Embolism (gaseous or particulate)
• Exposure to airborne infectious agents
• Exposure to biohazards
• Exposure to bloodborne pathogens
• Exposure to hazardous gas
• Exsanguination
• Extravasation
• Failure to deliver therapy
• Fire
• Hemolysis
• Hemorrhage
• Hyperthermia
• Hypothermia
• Infection
• Infiltration
• Interruption of therapy
• Ischemia
• Mechanical (puncture, perforation, laceration, break, cut, tear, nick, crush)
• Misdiagnosis
• Monitoring failure
• Overdose
• Particulates
• Pressure necrosis
• Suffocation
• Underdose
• Various
• Wrong drug