Established processes on handling defective equipment can save hospitals from the risk of potentially costly litigation.
Several years ago, a patient filed a claim involving a portion of a guide wire that broke off inside of their body during placement of a vascular stent. The time and expense dedicated to the delicate process of retrieving that retained portion of stent along with medical complications suffered by the patient resulted in a lawsuit alleging significant damages.
In addition to the issue of medical malpractice, it was alleged that the hospital was guilty of “spoliation” of evidence. Spoliation has been defined in some reference texts as the “intentional, reckless or negligent withholding, hiding, altering, fabricating or destroying of evidence relevant to a legal proceeding.”
In this case, the hospital discarded the portion of guide wire that had broken off after removal. There was no evidence this was done intentionally. In fact, there was testimony that a great deal of effort was made to root through the hospital’s waste to try and locate the article after disposal. Despite a good deal of circumstantial evidence, the co-defendant manufacturer of the guide wire took the position that it could not be proven the guide wire was their product without the ability to inspect the actual product used in the procedure.
Furthermore, the court ruled that the allegation of “spoliation” fell outside the parameters of the Louisiana Medical Malpractice Statute so that there would be no “cap” on damages if the spoliation claim was accepted should the case proceed to trial.
As you can see, the hospital would not have been a party to this litigation if it simply had a process or followed an established process for securing the piece of guide wire once it was removed from the patient. This claim was eventually settled with contributions from the hospital, the manufacturer and the Patient’s Compensation Fund.
On a national level, recalls of certain products such as surgical meshes and heparin syringes have been the subject of class action litigation. In some instances, those recalled products that had already been used on a patient–specifically the surgical mesh–were successfully removed from the patient but discarded after removal by the hospital. This again resulted in spoliation allegations and protracted expensive litigation for the hospitals in question.
In order to mitigate risks associated with defective equipment, it is important for facilities to have processes in place. Implement policies to include best practices, documentation and reporting requirements related to faulty equipment. Educate staff on these policies, train personnel on current techniques and verify competency.
It is imperative for staff to secure and remove any malfunctioning device from service. All manuals, contract and other documents related to the device must also be secured. Staff is required under the Safe Medical Device Act (SMDA) to report serious events, illnesses, injuries or deaths caused by or related to medical devices. If a device has caused or contributed to a death, staff must report to the manufacturer (if known) and the FDA within 10 working days. If the device has or may have caused or contributed to a serious injury, a report to the product manufacturer is necessary within 10 working days of notice. If the manufacturer is unknown, staff must report the events to the FDA via Electronic Medical Device reporting (Emdr). Designate staff responsible for reporting these occurrences.
Medical device tracking via the FDA Modernization Act of 2002 requires the hospital to collect patient identifying information for each patient who receives a tracked device and submit it to the manufacturer confidentially per HIPAA guidelines. Records are to be maintained as a long as the device is in use or in distribution for use. The list is updated on an ongoing basis at www.fda.gov.
It is essential that reporting includes developing a standardized process to review and disseminate information about product recalls, notifications and safety alerts to appropriate departments and individuals as well.
Following these guidelines will prevent risks of litigation associated with defective devices:
- Implement policies and educate staff related to best practices, documentation guidelines and reporting requirements.
- Identify all patients with a tracked device.
- Designate staff to handle reporting, notification and safety alerts.
- Secure defective devices and all associated documentation related to this device.
- Report deaths related to a device to the FDA and the manufacturer within 10 working days of notice.
- Report serious injuries related to a device to the manufacturer within 10 working days of notice or, if unknown, to the FDA.
- Develop a standardized process to review and disseminate information about product recalls.
Joyce Benton, RN, MSA, ARM, CPHRM, LHRM, DFASHRM Risk Control Director, CAN Healthcare. Legal and Regulatory. ASHRM of the AHA. 2014, pgs. 126-128.
If you have any questions related to this newsletter, please contact: