Medical Device Recall...

Information & Training. | Medical Devices

Health care providers typically place endotracheal tubes into a patient’s airway (trachea) to help establish and maintain their airway and to ensure the adequate exchange of oxygen and carbon dioxide. The Vyaire Medical Tri-Flo Subglottic Suction System can be used to remove liquids or semisolids that block an adult patient’s airway when an endotracheal tube is in place.

Reason for the Medical Device Recall:
Vyaire Medical Inc recalled the Tri-Flo Subglottic Suction System because there was a risk that the distal soft tip of the catheter may break off and enter the patient’s lungs.

This could result in serious adverse health consequences including choking, wheezing, additional surgery to remove the tip from the patient’s lungs, irritation and reddening of the skin (erythema) of the airways, infections or death.

FDA consideration:
The FDA has identified this recall as a Class 1 recall, which is the most serious form of recall. This is due to the potential serious effects if a device breakage were to occur while in use.

FDA statement >>>

What can we learn from this particular Medical Device Recall:
Unfortunately, Medical Devices can and do fail while in use. How best to prevent? Clearly, all medical devices need to undergo comprehensive design validation which is based on risk assessments which identify the high-risk areas, if indeed a product or component of a product were to fail. Once fully validated, there remains a need to ensure ongoing effective process controls and monitoring of materials and suppliers needs to be in place to ensure no degradation of the product due to lower quality materials getting into the supply chain.

Information & Training.

Medical Device:

- - Validation. Classification. Regulation. Requirements. Current best practices.
  - FDA cGMP’s. EU MDR’s / MDD’s.
  - FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
  - FDA Medical Device Classification. The FDA approach to Medical Device Classification.
  - EU Medical Device Regulation and Classification (per MDD’s).
  - ^New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
  - Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
  - Quality System requirements to maintain compliant Validations.
  - Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
  - Medical Device Software Validation.
  - Medical Device Design Validation.
  - Electronic Signature, Electronic Records.
  - Life Cycle Approach to Validation.
  - Risk Identification. Documentation. DHR’s. DMR’s.
  - Etc. Etc. …
  - Information & Training presentation >>>