Although the healthcare professional might be the one to discover the problem, the ultimate responsibility for reporting device‐ related events to the manufacturer and/or FDA rests with the user facility. The healthcare professional does not need to determine if a device‐related incident is reportable to FDA or the manufacturer. The user facility investigating team will make this determination within the requirements of MDR.

Above and beyond following internal reporting policies in their user facility, healthcare professionals are encouraged to take an active role in developing the mandatory device monitoring system which will provide an effective mechanism for data collection, documentation, and evaluation

The MDR regulation specifies that the following be done in all user facilities :

• Obtain copies of the MDR regulation, reporting forms and instructions, and coding manual.

• Designate an MDR contact person (e.g., the facility administrator, risk manager, or biomedical/clinical engineer).  The contact person can   rely on a committee to determine reportability of events.

• Develop written procedures explaining how the user facility intends to comply with MDR requirements (usually these procedures have been added to the monitoring systems already present in the facility)

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• Start a file of reports and information that is sent to FDA and the manufacturer. Files must be kept not only for events which were reported, but for those not reported, and must be maintained for two years.

• Develop internal systems to identify device‐related events, determine which events must be reported, provide documentation of decisions, and ensure that forms are properly completed and submitted within the required time frame.

N o t e : The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) will be reviewing compliance with MDR during their site visits. User facilities can also be visited by FDA investigators to determine whether they are in compliance with MDR.

VOLUNTARY REPORTING BY HEALTH CARE PROFESSIONALS

The second reporting mechanism , voluntary reporting by healthcare professionals, is just as vital as mandatory MDR in protecting the safety of patients and device operators.

Under MEDWATCH, FDA’s Medical Products Reporting Program, health professionals are encouraged to report serious adverse events and product problems with all medical products (i.e., drugs, biologics, medical devices, and special nutritional pro d u c t s , including dietary supplements , infant formulas , and medical foods) to FDA and/or the manufacturer.

Health professionals use the voluntary reporting form (FDA 3500). Whenever a device fails to perform as expected, it should be kept, as well as any other material evidence that could be used if an investigation of the product is made (15) Medical devices should not be sent to FDA.

The definition of a serious adverse event is broadly defined within voluntary reporting to include any patient outcome that results in  death, a life‐threatening eve n t , hospitalization (initial or prolonged), disability, a congenital anomaly, or if medical or surgical intervention was required to prevent permanent damage. Health professionals do not need to prove causality; a suspected possible association between a product and an adverse patient outcome is sufficient reason to report.

FDA is also interested in reports of product problems such as inaccurate or unreadable labeling, packaging or product mix‐up, contamination or stability problems, defective devices, or product confusion (caused by name, labeling, design, or packaging).

When can the voluntary system be used to report problems with medical devices?

1.  To report medical device events occurring in clinical settings which are exempt from user facility reporting (such as the office of a physician, nurse practitioner, or dentist). Events that are particularly important to report are serious device malfunctions that result in a death or injury, or when a device‐ related condition is created that may be unsafe, hazardous, or otherwise presents a public health concern. FDA is not interested in reports from health professionals if personal preference is at issue rather than device performance.

2.  To report some medical device events occurring within a user facility (it is usually the user facility that makes the decision to file a voluntary device report). User facilities are encouraged to use the mandatory version of the form , F DA 3500A, even though the reporting is voluntary, because the 3500A requests additional necessary information about the device incident.

• Voluntary reporting is appropriate for a "near miss" (i.e., under slightly different circumstances, a serious injury or death might have occurred) When a potential hazard is recognized, corrective action should always be taken. FDA encourages the voluntary reporting of "near misses" to the device manufacturer (16)

• The voluntary reporting mechanism can also be used for reporting user error not resulting in death or serious illness/injury, because such events may indicate that the labeling for a device does not provide adequate directions for use or adequate warnings (17)

• Finally, voluntary reporting of device‐ related problems in a user facility is appropriate for device‐related events not reportable under the law (i.e., not causing or contributing to serious illness/injury or death) which affect product quality such as defective devices, inaccurate or unreadable product labeling, packaging or product mix‐ up, contamination, or stability problems.

It is important to note that voluntary reporting on the FDA 3500 by health professionals does not satisfy their user facility's medical device reporting requirements under MDR. Health professionals should follow the intern a l incident reporting procedures within their facilities for all device ­ related events. However, health professionals can file an individual report using the FDA 3500 form.

WHAT HAPPENS TO YOUR REPORT?

Reports sent to the device manufacturers:

Upon receiving a report from a user facility or an individual healthcare professional, a manufacturer must investigate, evaluate, and identify the underlying causes of any adverse event reported to them. (The manufacturer usually contacts the reporter to obtain as much information as possible so that the manufacturer can investigate the event and complete their report to FDA.) FDA periodically inspects manufacturers for compliance with manufacturing and reporting requirements. In addition , device distributors must also report device‐related deaths, serious injuries , serious illnesses, a n d malfunctions to FDA with a copy to the manufacturer .

(18) In some cases the problem might be resolved by means of relabeling or a recall. For example, MedWatch received a call from a dental office reporting that an employee had been momentarily unable to release her hand from an ultrasonic cleaning device. FDA's investigation revealed that there was electrical leakage from the lid even though the unit was turned off. In another incident, an electrical fire started in an ultrasonic device that had been turned off prior to cleaning. The manufacturer identified the cause of the problem and initiated a recall. (1)

Reports Sent to FDA:

When FDA receives a report from a user facility or an individual health professional, it is entered in the medical device postmarket surveillance database, and subsequently compared to other information. Part of this review is to evaluate any past problems with the device, particularly those which may present an immediate risk to the public health.  All voluntary reports that are received by MedWatch are sent to the manufacturer for follow‐up. FDA staff also look at actual or potential risk, and ensure that appropriate corrective action is initiated. Not all reports involve problems that re q u i re immediate resolution. FDA continually reviews the database to detect problems, trends, and potential hazards.

As a result of such trend analysis, FDA staff noticed a gradual increase in the number of deaths associated with the use of hospital bed side rails (19)

Between January 1990 and June 1995, F DA received 102 reports of head and body entrapment incidents involving hospital bed side rails.  Although one entrapment occurred with a 2 year old patient, the majority of deaths and injuries involved elderly patients. This prompted FDA to mail a Safety Alert entitled Entrapment Hazards with Hospital Bed Side Rails on August 23, 1995 to over 94,000 hospitals, nursing homes, hospices, nursing associations, and home healthcare agencies.

Each year, F DA receives approximately 100,000 reports through the MDR route and 5,000 device reports through the voluntary MedWatch route. Nurses are active device reporters, submitting about 25% of the voluntary device reports (biomedical engineers and other technicians/ technologists submit about 21%, risk managers about 13%, and physicians about 8%). The remainder of the voluntary reports are submitted by pharmacists and dentists, with about 17% from non‐health professionals.

Confidentiality and Public Availability of Reports

FDA is aware that health professionals are concerned about the issue of confidentiality and public availability of reports.

Voluntary Reports ( reported on FDA 3500) from health professionals:

The patient’s identity is held in strict confidence by FDA and protected to the fullest extent of the law. FDA will not release any patient identifiers to the public.

Healthcare professionals can assist in this process by not using the patient’s name, initials, or other identifying information in block A1 (patient identifier) on the reporting form (i.e., leave it blank).

The reporter’s identity, including the identity of a self‐reporter, may be shared with the manufacturer unless requested otherwise (there is a check‐off box on the form).

However, FDA will not disclose the reporter’s identity in response to a request from the public, pursuant to the Freedom of Information Act.

On July 3, 1995, FDA published a regulation that extends this protection by preempting state discovery laws for voluntary reports held by drug, biologic, and medical device manufacturers (20)

Mandatory Reports (reported on FDA 3500A) from user facilities:

Certain information from user facility reports is available for public disclosure. Prior to public disclosure, FDA will delete:

•  Any information that constitutes trade secret or confidential commercial or financial information;

•  Any personal, medical, and similar information (including the serial number of implanted devices) which would constitute an unwarranted invasion of privacy; and

•  Any names and other identifying information of a third party voluntarily submitting an MDR report. This includes physicians, nurses, other healthcare professionals, or other hospital employees, unless they are the designated MDR contact person.

PROVIDING FEEDBACK TO HEALTH CARE PROFESSIONALS

Reports from health professionals and other sources provide valuable information about device problems. When risks or potential risks associated with the use of medical devices are identified by FDA, the agency issues a Notice (or letter), a Public Health Advisory, or a Safety Alert. This information is then mailed to hospital administrators, risk managers, biomedical engineers, pharmacists, and other agencies. It is also sent (via email or fax) to the M e d Watch Partners , rep resenting more than 130 health professional specialty organizations.

A Notice is usually a letter to healthcare professionals or healthcare organizations from FDA. Two recent examples are the April 17, 1997 Notice alerting health professionals to a potential infection problem with medical devices that are rented or leased by healthcare facilities, and the June 13, 1997 Notice entitled Radioactivity in Radiation Protection Devices.

A Public Health Advisory is generally issued when there has been a problem identified with a device and describes potential risk. For example, FDA issued a Public Health Advisory on March 21, 1994 entitled Avoiding Injuries fro m Rapid Drug or IV Fluid Administration.identified with a device and describes potential risk.