FDA recalls and updates

There recalls have recently been issued by the FDA:

  • 50% Magnesium Sulfate, USP by Hospira: Recall-presence of particulate matter
  • 5% Dextrose Injection, USP in PAB container by B. Braun Medical: Recall- leakage and particulate matter
  • Sodium Bicarbonate injection, USP by Hospira: Recall-particulate
  • Glidescope Titanium Single-Use Video Laryngoscope by Verathon: Recall-potential disruption of the video feed from the camera in the laryngoscope blade to the monitor.

Adequate inspection of the product mitigates the first three. However, the last one serves as a good reminder that we need backup for technology. What do you do if the camera stops working? Do you have an “old-fashioned” laryngoscope with the proper assortment of blades and a working light? Do you practice equipment failure scenarios during continuing education?

The purpose of a recall is to remove or correct products that the FDA considers in violation of the law. It is usually done by the manufacturer after negotiation with the FDA. When a recall is begun, the Congressional Research Service reports that the evaluation of the health hazard considers the following:

  • Have any diseases or injuries occurred from the use of the product?
  • Could the use of the product in existing conditions create a health hazard?
  • Which populations (children, surgical patients and others) would be exposed to a hazard with use of the product?
  • How serious is the hazard?
  • How likely is the hazard to occur?
  • What are the immediate and long-range consequences of the hazard?

Once these and other considerations are made the FDA assigns the recall a classification. Class I recalls are the most serious. There is a reasonable probability that use of or exposure to a product will cause serious adverse health consequences or death. Class II recalls are used when the adverse effects are temporary, medically reversible or the probability of serious adverse effects is remote. Class III is used when adverse health consequences are not likely to occur.

In the FDA “General Controls for Medical Devices”, devices are classified on the basis of the degree of difficulty in assuring safety and effectiveness.  Similar to the recall system there are three classes, except for device categorization Class I is the least stringent and Class III is the most.  A recent advertisement showed 1,500 pieces of medical equipment from an ambulance service for sale. Make sure that you are compliant with all legal requirements and that the product remains under warranty when buying medical devices directly from an ambulance service rather than from a licensed distributor. Licensed biomedical engineers should inspect and refurbish, as necessary, any device before it is used on a patient.

In March, the FDA proposed a ban on most powdered medical gloves. Their reasoning is “powder is sometimes added to gloves to make it easier to put them on and take them off. However, powdered gloves are dangerous for a variety of reasons. In particular, aerosolized glove powder on natural rubber latex gloves, but not on synthetic powdered gloves, can carry proteins that may cause respiratory allergic reactions. Although powdered synthetic gloves do not present the risk of allergic reaction, these devices are associated with an extensive list of potentially adverse events, including severe airway inflammation, wound inflammation, and post-surgical adhesions, which are bands of fibrous scar tissue that form between internal organs and tissues. These side effects have been attributed to the use of glove powder with all types of gloves.” Note that this is merely a proposal and not yet in effect. Consider it an early warning notice.


References

  • FDA News Release; “FDA proposes ban on most powdered medical gloves.” March 21, 2016
  • FDA General Controls for Medical Devices accessed at fda.gov/MedicalDevices
  • FDA Regulation of Medical Devices, Congressional Research Services Report for Congress

The information provided in this article is intended for general informational purposes only and should not be considered as all encompassing, or suitable for all situations, conditions, and environments. Please contact us or your attorney if you have any questions.

For safety or risk management questions or suggestions, please contact Markel.

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