Infection Control Today - 03/2003: IC BUSINESS

Medical Device Adverse-Event Reporting Saves Lives, Boosts Risk Management

By Patricia A. Tydell, BSN, MSN, MPH

The Safe Medical Devices Act of 1990 (SMDA) imposed significant new reporting requirements on the medical device industry and the users of medical devices. The law was designed to increase the information that the Food and Drug Administration (FDA) and manufacturers received about serious problems with medical devices. Although manufacturers and importers of medical devices have been required since 1984 to report to the FDA all device-related deaths, serious injuries and certain malfunctions, numerous reports showed widespread under-reporting.

A 1986 General Accounting Office (GAO) study showed that hospitals reported less than one percent of problems with medical devices and, the more serious the problem with a medical device, the less likely it was to be reported.1 A GAO follow-up study in 1989 concluded that despite full implementation of the Medical Device reporting regulation, serious under-reporting still existed (only seven percent of device incidents were reported to manufacturers).1

Under the SMDA, device-user facilities and manufacturers must report deaths and serious injuries which a device has or may have caused or contributed and must establish and maintain adverse event files. A medical device is defined as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagant, or other similar or related article, including any component, part or accessory, which is 1) recognized in the official National Formulary or the United States Pharmacopeia, or any supplement to them; 2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or 3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its intended purposes.2

Examples of medical devices in general care are hospital beds, catheters, syringes and steam sterilizers. Examples of devices in critical care are defibrillators, infusion pumps and cardiac monitors. Suture materials, bone screws, heart valves and anesthesia equipment are devices found in surgery and X-ray units, blood analyzers and ECG machines are examples from diagnostics and therapeutics.

The SMDA required that two new medical device groups must make reports to the FDA about serious device problems. One group was categorized as device-user facilities and included hospitals, ambulatory surgical facilities, outpatient treatment, but not physician's offices, and nursing homes. The other group was comprised of distributors of medical devices.

The law adapted a single reporting standard for manufacturers, distributors and users of medical devices that included a single definition of types of injuries that must be reported. Whenever the facility receives or otherwise becomes aware of information that reasonably suggests that a device has or may have caused or contributed to the death, serious illness, or serious injury of a patient of the facility, a report to the FDA must occur within 10 days. The definition of serious injury or illness that is used is life-threatening; or results in permanent impairment of a body function or permanent damage to a body structure; or necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.2

For example, an elderly patient in a nursing home whose head becomes entrapped in the side-rail bars resulting in anoxia to the brain and subsequent loss of the ability to ambulate would be a reportable incident. A catheter tip that breaks off during cardiac catheter procedure and necessitates surgical intervention to retrieve the tip would be a reportable incident also.

The report is made using the FDA's MedWatch reporting form. The form, along with the name and contact information of a representative of the facility, is sent to the FDA and manufacturer if known. In addition to individual reports of medical device problems, a semi-annual report is required. If any individual adverse event reports were submitted during the previous six-month reporting period, a user facility must submit a semi-annual report to the FDA on FDA form 3419. Semi-annual reports are due by January 1 and July 1.

Organizations have developed several ways to meet this reporting requirement. One of the most common is to have an ad hoc committee that is called to meet whenever the facility becomes aware of a death or serious injury/illness that a medical device caused or might have contributed to. The committee, composed of representatives from biomedical engineering, nursing, medicine/surgery, pharmacy, SPD, safety and risk management/patient safety, meets to review the incident and determine if the information it has reasonably suggests that a medical device contributed to the death or serious illness/injury of the patient. If the team determines that a device was implicated, and most teams err on the side of caution when deciding this, then the MedWatch form is completed and sent to the FDA and manufacturer. The adverse event is further investigated using the procedures established by the facility. Whatever method is developed to meet the law, the facility must have it in writing. (See Table 1)

The FDA uses these reports when determining whether or not to issue product alerts or recalls. Manufacturers use the reports in the same manner. The information gained from these reports has helped the healthcare community ensure safer patient care. When the FDA issued a nationwide and international alert on recalled OB/GYN and surgical devices shipped and labeled as sterile but in fact may not have undergone any sterilization process, many actual or potential infections were averted. Other alerts were issued for blood-collection sets, insulin syringes and hip implants.

The impact of these adverse events on the organization, the staff and patient/patient's family can be devastating. In addition to reporting the event to the FDA, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) requires that the patient and patient's family be notified when the outcome of care is not as anticipated. The standard is found in the Patient Rights chapter of the Comprehensive Accreditation Manual for Hospitals RI.1.2.2. The intent of the standard is that at a minimum, the patient, and when appropriate, the patient's family are informed about outcomes of care that the patient or family must be knowledgeable about in order to participate in current and future decisions affecting the patient's care.3 In the aforementioned example about the catheter tip breaking off during cardiac catheterization, the provider should tell the patient about the incident and that additional surgical intervention was needed to retrieve the tip. The patient must be aware that the procedure did not go as planned even though it was no fault of the practitioners involved. Had this adverse event met the definition of a sentinel event reviewable by JCAHO, then a root cause analysis would need to be conducted and the organization would need to determine if they were going to voluntarily report this event.

There is still a great deal of discussion and concern over notifying patients about adverse events that occur to them. The laws of each state that govern discoverability in a potential medical malpractice case are different, therefore, one state may require reporting of adverse events (New York) and others may not. Each hospital, nursing home, ambulatory care facility and outpatient treatment facility should seek the guidance of its legal counsel or from its insurance carrier concerning the actual procedures of notifying patients/patient's families of medical device related incidents. However, real-life experience shows that patients and their families want to be informed of problems when they arise and brought into the discussion of future care. Patients and families are more trusting of healthcare providers and the healthcare system when they are dealt with honestly and in a timely manner.

The simple act of reporting a medical device problem that caused or contributed to the death or serious injury of a patient has helped to avoid the same consequences for other patients.

Patricia A. Tydell, BSN, MSN, MPH, is risk manager at North Chicago Veterans Administration Center in North Chicago, Ill.

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