By Patricia A. Tydell, BSN, MSN, MPH
The Safe Medical Devices Act of 1990 (SMDA) imposed significant new reportingrequirements on the medical device industry and the users of medical devices.The law was designed to increase the information that the Food and DrugAdministration (FDA) and manufacturers received about serious problems withmedical devices. Although manufacturers and importers of medical devices havebeen required since 1984 to report to the FDA all device-related deaths, seriousinjuries and certain malfunctions, numerous reports showed widespreadunder-reporting.
A 1986 General Accounting Office (GAO) study showed that hospitals reportedless than one percent of problems with medical devices and, the more serious theproblem with a medical device, the less likely it was to be reported.1A GAO follow-up study in 1989 concluded that despite full implementation of theMedical Device reporting regulation, serious under-reporting still existed (onlyseven percent of device incidents were reported to manufacturers).1
Under the SMDA, device-user facilities and manufacturers must report deathsand serious injuries which a device has or may have caused or contributed andmust establish and maintain adverse event files. A medical device is defined as"an instrument, apparatus, implement, machine, contrivance, implant, invitro reagant, or other similar or related article, including any component,part or accessory, which is 1) recognized in the official National Formulary orthe United States Pharmacopeia, or any supplement to them; 2) intended for usein 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 toaffect the structure or any function of the body of man or other animals, andwhich does not achieve its primary intended purposes through chemical actionwithin or on the body of man or other animals and which is not dependent uponbeing 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 aredefibrillators, infusion pumps and cardiac monitors. Suture materials, bonescrews, heart valves and anesthesia equipment are devices found in surgery andX-ray units, blood analyzers and ECG machines are examples from diagnostics andtherapeutics.
The SMDA required that two new medical device groups must make reports to theFDA about serious device problems. One group was categorized as device-userfacilities and included hospitals, ambulatory surgical facilities, outpatienttreatment, but not physician's offices, and nursing homes. The other group wascomprised of distributors of medical devices.
The law adapted a single reporting standard for manufacturers, distributorsand users of medical devices that included a single definition of types ofinjuries that must be reported. Whenever the facility receives or otherwisebecomes aware of information that reasonably suggests that a device has or mayhave caused or contributed to the death, serious illness, or serious injury of apatient of the facility, a report to the FDA must occur within 10 days. Thedefinition of serious injury or illness that is used is life-threatening; orresults in permanent impairment of a body function or permanent damage to a bodystructure; or necessitates medical or surgical intervention to precludepermanent impairment of a body function or permanent damage to a body structure.2
For example, an elderly patient in a nursing home whose head becomesentrapped in the side-rail bars resulting in anoxia to the brain and subsequentloss of the ability to ambulate would be a reportable incident. A catheter tipthat breaks off during cardiac catheter procedure and necessitates surgicalintervention to retrieve the tip would be a reportable incident also.
The report is made using the FDA's MedWatch reporting form. The form, alongwith the name and contact information of a representative of the facility, issent to the FDA and manufacturer if known. In addition to individual reports ofmedical device problems, a semi-annual report is required. If any individualadverse event reports were submitted during the previous six-month reportingperiod, a user facility must submit a semi-annual report to the FDA on FDA form3419. 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 meetwhenever the facility becomes aware of a death or serious injury/illness that amedical device caused or might have contributed to. The committee, composed ofrepresentatives from biomedical engineering, nursing, medicine/surgery,pharmacy, SPD, safety and risk management/patient safety, meets to review theincident and determine if the information it has reasonably suggests that amedical device contributed to the death or serious illness/injury of thepatient. If the team determines that a device was implicated, and most teams erron the side of caution when deciding this, then the MedWatch form is completedand sent to the FDA and manufacturer. The adverse event is further investigatedusing the procedures established by the facility. Whatever method is developedto 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 productalerts or recalls. Manufacturers use the reports in the same manner. Theinformation gained from these reports has helped the healthcare community ensuresafer patient care. When the FDA issued a nationwide and international alert onrecalled OB/GYN and surgical devices shipped and labeled as sterile but in factmay not have undergone any sterilization process, many actual or potentialinfections 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 andpatient/patient's family can be devastating. In addition to reporting the eventto the FDA, the Joint Commission on Accreditation of Healthcare Organizations(JCAHO) requires that the patient and patient's family be notified when theoutcome of care is not as anticipated. The standard is found in the PatientRights 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 whenappropriate, the patient's family are informed about outcomes of care that thepatient or family must be knowledgeable about in order to participate in currentand future decisions affecting the patient's care.3 In theaforementioned example about the catheter tip breaking off during cardiaccatheterization, the provider should tell the patient about the incident andthat additional surgical intervention was needed to retrieve the tip. Thepatient must be aware that the procedure did not go as planned even though itwas no fault of the practitioners involved. Had this adverse event met thedefinition of a sentinel event reviewable by JCAHO, then a root cause analysiswould need to be conducted and the organization would need to determine if theywere going to voluntarily report this event.
There is still a great deal of discussion and concern over notifying patientsabout adverse events that occur to them. The laws of each state that governdiscoverability in a potential medical malpractice case are different,therefore, one state may require reporting of adverse events (New York) andothers may not. Each hospital, nursing home, ambulatory care facility andoutpatient treatment facility should seek the guidance of its legal counsel orfrom its insurance carrier concerning the actual procedures of notifyingpatients/patient's families of medical device related incidents. However,real-life experience shows that patients and their families want to be informedof problems when they arise and brought into the discussion of future care.Patients and families are more trusting of healthcare providers and thehealthcare system when they are dealt with honestly and in a timely manner.
The simple act of reporting a medical device problem that caused orcontributed to the death or serious injury of a patient has helped to avoid thesame consequences for other patients.
Patricia A. Tydell, BSN, MSN, MPH, is risk manager at North ChicagoVeterans Administration Center in North Chicago, Ill.