Deviation in the Standard of Surgical Care for Using Ineffective, Inadequate, or Inappropriate Implant (Non-Plastics)

Evaluate breaches in the standard of care by using the following questions and answers as a guide to determine whether or not there was Deviation in the Standard of Surgical Care for Using Ineffective, Inadequate, or Inappropriate Implant (Non-Plastics)

Answer the following questions to find out if the standard of care was followed for your case.

  • Was the implant clinically tested before being marketed?
    Yes
    No
    Answer unknown
    Why is this important?
    The Center for Devices and Radiological Health (CDRH) is the component of the FDA responsible for administering the regulatory function pertaining to medical devices. All new medical devices need to be reviewed by the appropriate division of the CDRH.
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  • Did the medical device contain a unique device identifier label (UDI) as required by the U.S. FDA? Why is this important?
    Answer this question
    
Pre-market controls are designed to ensure that all medical devices placed on the market comply with regulatory requirements, meet safety performance and labeling requirements. Pre-market regulatory activities are aimed at ensuring quality in medical device design and manufacturing.

    (2007) 76 EIJMDI S 1 S35-S47 



  • Was the implant manufacturing company registered with the U.S. FDA? Why is this important?
    Answer this question
    
All manufacturers are required to register each manufacturing location with the FDA.

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  • Was an informed consent obtained from the patient prior to the surgery? Why is this important?
    Answer this question
    
Physicians have a legal and ethical responsibility to provide adequate information to the patient so that he or she is able to process the information and make appropriate decisions. No intervention can be undertaken without the patient’s written consent.

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  • Were prophylactic antibiotics administered to the patient prior to surgery? Why is this important?
    Answer this question
    
Infection is the most common serious complication of surgical implants. Antimicrobial approaches are intended to prevent implant-associated infections.

    (2012) 38 BIOSE 1 226-232 



  • Was a thorough pre-operative evaluation performed? Why is this important?
    Answer this question
    
A thorough medical history and physical examination must be performed to assess patient-related risk factors, assess the status of the patient’s co-morbid conditions, and to assess the patient’s overall health.

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  • Was the clinician trained in the surgical implantation technique? Why is this important?
    Answer this question
    
The success of the implantation depends heavily on clinician training and experience.

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  • Was the patient’s implant properly selected? Why is this important?
    Answer this question
    
Success of implant placement is related to proper device selection, patient selection, surgical indications and technique.

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  • Which of the following complications did the patient experience? Why is this important?
    Answer this question
    
Loss of fixation and/or implant failure that occurs after a reasonable expected healing period is most often indicative of nonunion. Early loss of fixation is more frequently a consequence of inadequate initial fixation.

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  • Were the complications treated immediately? Why is this important?
    Answer this question
    
Post-operatively, the clinician must assess the patient for signs and symptoms of surgical complications, signs of infection, and signs of implant failure.

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  • Did the clinician document the make, model and serial number of the medical implant/device? Why is this important?
    Answer this question
    
It is required that all information regarding the implant be fully documented in the medical record. Full information of any implants in the operative notes such as make, model, and serial number, all must be conclusively documented in the medical records.

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  • Was the implant failure caused by a flaw in the product? Why is this important?
    Answer this question
    
All implant failures require a root cause analysis study to determine if it is a product flaw or a surgical complication.

    (2002) 14 ECCNCN 4 407 



  • Was the injury reported to the product’s manufacturer? Why is this important?
    Answer this question
    
If a manufacturer is informed by a clinician or hospital about a death or injury that occurred as a result of its product, it is legally obligated to investigate the event and report it to the FDA.

    (2002) 14 ECCNCN 4 407-416 



  • Did the manufacturer report the adverse event to the FDA? Why is this important?
    Answer this question
    
Manufacturers are required to report medical device events whenever they discover that their device may have caused or contributed to a serious injury or death.

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  • Did the medical facility file an annual report to the FDA? Why is this important?
    Answer this question
    
Hospitals and other user facilities are required to report device-related deaths to the manufacturer and to the FDA. In addition, the hospital is required to report device-related serious injuries to the manufacturer.

    (2002) 14 ECCNCN 4 407-416 



  • Was an explant retrieval and analysis performed? Why is this important?
    Answer this question
    
Examination of explanted joints that have failed or caused problems in the body is one of the most valuable sources of data about how and why implants fail. 

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