Dear SIRS refers to the Safety Information Response System. The purpose of this column is to allow expeditious communication of technology-related safety concerns raised by our readers, with input and responses from manufacturers and industry representatives. This process was developed by Drs. Michael Olympio, Chair of the Committee on Technology, and Robert Morell, Editor of this newsletter. Dr. Olympio is overseeing the column and coordinating the readers' inquiries and the responses from industry. Dear SIRS made its debut in the Spring 2004 issue.
The information in this column is provided for safety-related educational purposes only, and does not constitute medical or legal advice. Individual or group responses are only commentary, provided for purposes of education or discussion, and are neither statements of advice nor the opinions of APSF. It is not the intention of APSF to provide specific medical or legal advice or to endorse any specific views or recommendations in response to the inquiries posted. In no event shall APSF be responsible or liable, directly or indirectly, for any damage or loss caused or alleged to be caused by or in connection with the reliance on any such information.
The Role of ECRI in Medical Device Incidents
As coeditors of this column, it is very important that we explain to our readers what established methods of device reporting and improvement already exist within the United States. Although this column may be interesting and well-intended, it is not capable of being an authoritative or scientific means of improving medical device safety.
For this, we turn to our experts, and want them to explain how to handle your device safety issues. Engineer Albert de Richemond, representing ECRI Institute, is a member of the Board of Directors of the APSF, and has been most helpful in promoting our efforts in patient safety. What can he clarify for each of us? How does Dear SIRS differ from ECRI Institute problem reporting?
Michael A. Olympio, MD
Drs. Olympio and Morell asked me to provide guidelines for you on clinician reporting of adverse events with medical devices. Reporting of such incidents for the betterment of health care should be considered whenever a patient or staff member is harmed or is likely to have been harmed by a medical device or therapy. Reports can be communicated to ECRI Institute, to your state department of health, to the US Food and Drug Administration (FDA), or to Dear SIRS. Dear SIRS and ECRI Institute may provide direct feedback to the reporter; most governmental reporting systems do not.
Medical devices sometimes fail. Users occasionally make errors. These adverse events include such incidents as patient injury or death, near misses (an error that was caught before it caused harm), misdiagnosis, inadequate or inappropriate therapy, and never events (e.g., wrong site surgery, overdose, retained instrument, surgical fire). As a result of an adverse event, patient care can be adversely affected. However, with proper foreknowledge, many device-related incidents can be avoided—either through improved device design or user training. That is where problem reporting comes in. Collecting and studying problem report information not only can help investigators identify the cause of an incident, but it also can help warn others in time to prevent similar incidents through "work-arounds" or device improvements.
ECRI Institute strongly encourages health care providers, patients, and manufacturers to report medical-device-related incidents and deficiencies to us so we can determine whether a report reflects a random failure or one that is likely to recur and cause harm. Our Problem Reporting Network (PRN) began operation in 1971 and became the model for the medical device problem reporting systems that followed. The PRN program is described on the Internet at http://www.ecri.org/PatientSafety/ReportAProblem/Pages/default.aspx. Confidential reports can be electronically submitted to ECRI using our Problem Reporting Network form available through the website.
Each report we receive is logged into our system and is individually discussed by our scientific and engineering staff at our weekly triage meeting. In cases where we can provide guidance related to the report, we inform the reporting party of our findings and opinions. Otherwise, we monitor the situation for developing trends of similar problems. As soon as members of our staff determine that specific device hazards and problems may exist, we inform the manufacturers and encourage them to respond constructively and correct the problem. (The problem reporter's identity and facility are never revealed without permission.) In many cases, we publish the results of our investigations of reported problems—along with appropriate warnings and recommendations—in Health Devices and Health Devices Alerts.
About half of the US's state departments of health now require reporting of adverse events. Most of these programs are intended to improve the quality of health care by collecting information and disseminating reports about the problems and solutions. To do this, some states have newsletters or other methods of publishing information. A listing of the various state codes concerning adverse event reporting can be found at: http://www.nashp.org/_docdisp_page.cfm?LID=2A789909-5310-11D6-BCF000A0CC558925. Depending on the state requirements, facilities may be required to act to correct the reported problem in various ways.
In cases where a serious injury or death results or is likely to have resulted from an adverse event, hospitals may also be required to report the problem to the device manufacturer or to the FDA under their MedWatch program or the MedSun program, which is a subset of MedWatch with 350 participating facilities. The FDA encourages voluntary reporting of adverse events.
Under the FDA MedWatch program, reports may be sent to the device manufacturer or to the FDA. The decision on whom to send the report to depends on the seriousness of the incident and whether the manufacturer is known. See the FDA MedWatch reporting website (http://www.fda.gov/medwatch/how.htm) for details and reporting forms.
MedWatch data are collected in the Manufacturer and User Facility Device Experience (MAUDE) database. This database is publicly searchable and does not contain the name of the reporter, the facility, or the patient. In cases of serious device issues, the FDA can legally act through the marketplace to prevent further harm, e.g., device recalls, prohibition of device sales. Through the MedSun program, some reported problems and solutions are discussed in the MedSun Monthly Newsletter that is sent to participating facilities.
Potentially, there are various legal repercussions when an adverse event occurs. Your facility's risk management department, which would likely file the needed reports, should be made aware of the incident so they can knowledgeably help in dealing with the event. The fact that a medical device was involved in an adverse event does not in itself trigger a mandatory report. For each event, it is important to ask whether or not the event can be attributed to the device, or whether the device was or may have been a factor in the death or injury.
Medical device problem reporting requirements are not satisfied by publication in Dear SIRS. While reporting problems to Dear SIRS is helpful in disseminating medical device information to a broad audience, it may not help solve the underlying cause of the problem. Additionally, legal problems may argue against publication in Dear SIRS. However, because bringing problems to light helps solve them, we recommend reporting to the proper authorities and to Dear SIRS, if possible.
In summary, Dear SIRS, ECRI Institute, state, and FDA programs gather adverse event information in order to inform the health care community (including clinicians, suppliers, and consumers) about potential problems and how to prevent them. If you become aware of an incident in which a patient or staff member was harmed or was likely to have been harmed, reporting to the various authorities should be considered and may be mandated under state or FDA programs.
We thank Engineer Albert de Richemond and the ECRI Institute for this valuable and detailed information and emphasize that harm is not a pre-requisite to reporting. In fact, Dear SIRS is typically not suitable for incidents involving harm to patients or staff members.