FDA Issues Highest Alert for Hospital Beds That Could Kill Patients

a hospital bed

More than 8,500 high-tech hospital beds have been recalled amid concerns that they could kill or lead to life-threatening patient injuries.

According to a report in The Daily Mail, the smart beds were found to interfere with nearby medical devices, including baby heart monitors, infusion pumps, and other critical medical equipment. Baxter International, based in Illinois, has initiated the recall of about 8,550 units of its WatchCare Incontinence Management System, which are typically used in critical care and operation theaters to alert caregivers when incontinent patients have had an accident.

Details of the Hospital Beds Recall

These defective devices were initially rolled out in 2018. Staff members at hospitals where these beds are in use have been urged to double-check all unexpected or atypical results and monitor infusions closely. The U.S. Food and Drug Administration (FDA) has classified this recall as “Class One,” which is the most serious type of recall. The recall was based on 96 reported complaints of interference with no reports of injuries or deaths related to the product. All but two of the 96 interference incidents occurred when the medical device was less than a meter away from the hospital bed.

The beds are apparently used for a wide range of patients, from women who are in labor to those suffering from dementia. Baxter notified customers of the recall in late September. In a letter, the company cautioned users about the potential for the beds’ radio frequencies to interfere with other medical devices, such as glucose sensors, insulin pumps, and bladder scanners.

Baxter has said it has sought to locate and remove the device from clinical care areas where possible. The manufacturer has asked all hospitals that have these beds to pinpoint all affected devices and halt the use of the WatchCare system accessory while it delves into what is causing this issue.

In the meantime, the company will also be in touch with consumers to arrange for the accessory to be temporarily disabled. Anyone who experienced negative reactions relating to these products is asked to report them to the FDA’s safety information and adverse event reporting program through an online form, regular email, or fax. Many of the recalled WatchCare devices were made by Hillrom, which was acquired by Baxter in late 2021.

Defective Medical Devices and Product Liability

While advances in medical technology can provide a number of benefits to patients who are in need of new treatments, when these devices suffer from design flaws or manufacturing defects, the consequences can be devastating. Defective medical products and devices could result in catastrophic injuries or even fatalities. In many of these product defect cases, including those that involve faulty medical devices, it is up to the patient or a family member to take legal action against the manufacturer of the device in order to recover compensation for their losses.

As with other types of product liability and personal injury cases, plaintiffs in defective medical device cases must establish liability on the part of the product manufacturer. Typically, these types of cases accuse manufacturers of failing to meet some basic safety and efficacy standards, including but not limited to:

  • Manufacturing defects
  • Design flaws
  • Failure to warn consumers of dangers
  • Improper labeling
  • Deliberately hiding information from consumers and medical professionals
  • Negligence (carelessness)

Depending on the nature and extent of the injuries, these types of cases can be complex and challenging. An experienced defective product lawyer who is knowledgeable and resourceful will be able to help injured victims build a strong case and seek compensation for their injuries, damages, and losses.

FDA Regulations

The U.S. Food and Drug Administration (FDA) requires manufacturers to report device-related incidents to the agency. These incidents can include deaths, serious injuries, and device malfunctions that are likely to cause or contribute to serious injury or death. Healthcare facilities are required to report patient deaths suspected of being associated with devices to both the manufacturer and the FDA. Users are only required to report serious injuries to the manufacturer or to the FDA if the manufacturer is not known.

The following definitions identify reportable events:

  • Serious injury: Life-threatening injuries or injuries that result in permanent damage or impairment, as well as injuries that require medical intervention to preclude permanent damage or impairment.
  • Malfunction: The failure of a device to meet its performance specifications or to perform as intended. A malfunction should be reported if it is likely to be dangerous.
  • Medical Device Reporting (MDR): The MDR system is used to monitor device-related adverse events, including deaths, serious injuries, and device malfunctions. The system is intended to provide the FDA with significant medical device adverse event information from manufacturers, importers, and user facilities.
  • MedWatch: MedWatch is the process by which both mandatory and voluntary adverse events are reported. Healthcare facilities use the MedWatch form to report events. Healthcare practitioners and patients may also use the form to voluntarily report adverse events.

Manufacturers are required to report a device-related death, serious injury, or malfunction to the FDA within 30 days of becoming aware of the event. Issues should also be reported within five work days if there is an unreasonable risk of substantial harm to public health or when required by the FDA for specific devices or types of events.

Contact a Product Liability to Find Out If You Have a Claim

If you or a loved one has been injured as the result of a defective product or defective medical device, an experienced product liability lawyer can help you better understand your legal rights and options. You may be able to seek compensation for damages such as medical expenses, lost income, hospitalization, pain and suffering, and emotional distress.

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