Are you prepared to deal with medical device and drug recalls?

In 2022, the FDA has issued over 70 Class I medical device recalls, its highest risk classification, compared to an average of 47 over the previous five years. Class III devices, including infusion pumps, fluid warmers, implantable cardioverter defibrillators, endotracheal tubes, automatic transport ventilators, syringe administration sets, monitor/defibrillators, sterile saline, sterile water, and test strips to monitor the effects of warfarin, are among those that require attention.

Additionally, the FDA issued drug recalls for Ibuprofen concentrated oral suspension, losartan potassium, losartan potassium hydrochlorothiazide (HCTZ), Ibersartan, Rhino 5 K capsules, Vecuronium bromide for injection, Ceftriaxone for injection, amlodipine valsartan, and many others. 

Do you have a system in place to identify which devices and drugs your system uses that have been subject to recall? Could any of these recalls impact the way you need to evaluate and treat patients? The FDA maintains a searchable website for drug recalls that is open access. 

The purpose of a recall is to remove or correct products that the FDA considers in violation of the law. Manufacturers must report deaths, serious injuries, and certain malfunctions to the FDA within 30 calendar days of becoming aware. Certain events requiring remedial action, however, must be reported within five workdays. 

The FDA also requests health care professionals and consumers to report adverse reactions or quality problems they experienced using these devices to MedWatch: MedWatch is the FDA Safety Information and Adverse Event Reporting Program, which can be accessed through an online portal on the FDA website. 

If a recall is initiated, it i's usually done by the manufacturer after negotiation with the FDA. When a recall is started, the subsequent evaluation of the health hazard considers the following: 

1. Have any diseases or injuries occurred from use of the product? 

2. Could use of the product in existing conditions create a health hazard? 

3. Which populations (children, surgical patients, the elderly, and others) would be exposed to a hazard with the use of the product? 

4. How serious is the hazard? 

5. How likely is the hazard to occur? 

6. What are the immediate and long-range consequences of the hazard? 

Recall classifications

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 or medically reversible or the probability of serious adverse effects is remote. Class III is used when adverse health consequences are not likely to occur. 

Medical device classifications

The range of medical devices is staggering. The FDA has classified about 1,700 generic device types. They are grouped into 16 medical panels and assigned to a regulatory class.  

There are three classes of medical devices. Unlike recall types, the higher the medical device class the greater the potential for harm.  

Class I medical devices have low to moderate risk for the patient or user. Examples include enema kits, elastic bandages, manual stethoscopes, and bedpans. About 47% of medical devices fall into this category.  

Class II medical devices pose moderate to high risk, account for around 43% of medical devices, and include items like powered wheelchairs and pregnancy test kits. Are you surprised that a powered wheelchair is classified as a moderate to high-risk medical device?  

About 10% of medical devices are Class III which pose a “potentially unreasonable” high risk to the patient or user. They are usually life support or life sustaining devices, like implantable pacemakers, but breast implants are also Class III. 

Recall notifications and procedures 

You can subscribe to receive medical device and drug recalls on the FDA website. Go to the website and determine if you've missed anything listed in the first paragraph. There should be policies, procedures, and designated individuals to address recall issues. 

There have been reports that emergency medical devices and medications shortages are so severe that services are not able to meet minimum requirements and are required to obtain waivers from regulatory agencies to continue operations.  

This may create a market for used medical devices. When buying them, make certain that you are compliant with all legal requirements. Check with local legal counsel. Any biomedical devices should be properly labeled.  

Determine if the product remains under warranty. Licensed biomedical engineers should inspect and refurbish, as necessary, any device before it is used on a patient. Remember a powered wheelchair is a Class II medical device. Note that spine boards, cots and the like have a “useful life”. 

When medications used for emergency care are recalled, it may create a shortage. Do you have a plan to source these medications from other manufacturers or compounding pharmacies? Do you have treatment guidelines that allow for the substitution of other medications or rationing?  

Does your agency have a plan policy detailing how to manage a medical device failure internal as well as external notifications that need to be made? 

References 

FDA Regulation of Medical Devices, Congressional Research Services Report for Congress 

FDA General Controls for Medical Devices http://www.fda.gov/MedicalDevices Accessed August 30, 2019 

https://www.fda.gov/medical-devices/consumers-medical-devices/learn-if-medical-device-has-been-cleared-fda-marketing 

https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls 

https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program