IDENTIFYING AND AVOIDING PROBLEMS WITH MEDICAL DEVICES

Types of Problems

Problems with medical devices generally fall into one of the following three broad categories:

•  Device Problems:

Device problems include malfunctions (e.g., mechanical, electrical, or software ‐ related) , manufacturing defects in product design or development, or material problems such as product instability.

•  Use Problems:

Use problems may be caused by inadequate or misleading labeling, confusing instructions, inadequate confusing instructions, inadequate packaging, design problems which make the device difficult to use, or inadequate training in the use of the device.

Use problems can cause or induce user errors. (See boxed information “Human Factors” on this page).

•  Clinical Problems:

Clinical problems can occur with a patient who is sensitive or allergic to a device, has a preexisting condition that makes the device difficult or risky to use, or in whom the device would have an inherent risk.

Avoiding problems

Healthcare professionals can do some simple things to avoid common problems with medical devices:

–understand how a device should be used, and for which patients it is probably not safe

–be familiar with the instructions and other labeling

–inspect and test equipment prior to use make sure that devices are properly maintained and serviced

–do not use a device that has malfunctioned until it has been “cleared” by the appropriate facility staff (i.e., biomedical engineering)

–understand that the manufacturer may not be held liable for patient injury if a medical device is used in a manner not specified in the labeling (8,9,10)

–do not use a device past its expiration date

REPORTING DEVICE­RELATED PROBLEMS:

Healthcare professionals are encouraged to report medical device problems directly to the manufacturer and/or FDA whenever it is suspected that the product caused or contributed to an adverse outcome. However, health professionals who practice in hospitals, outpatient treatment, diagnostic, and surgical facilities, or long term care facilities need to be aware that their facility is responsible for reporting serious device‐related events to the manufacturer and/or FDA. These types

of facilities are called device "user facilities." The key to effective reporting is to understand the two complementary avenues for national adverse event reporting:

•  Medical Device Reporting (MDR) requires device user facilities, manufacturers, and distributors to promptly notify FDA about device‐ related events that may have caused or contributed to a death, serious illness or injury; and MedWatch, the FDA Medical Products Reporting Program, which encourages individual health professionals to notify FDA and/or the manufacturer about serious adverse events and product problems with medical products. (i.e., events not reportable under MDR).

MEDICAL DEVICE REPORTING (MDR) BY USER FACILITIES

The purpose of MDR is to ensure that the most serious problems with medical devices will be identified at the level of the user and will be reported by the user facility to the manufacturer and/or the FDA.  The MDR regulation was published on December 11, 1995 and became effective on July 31, 1996. This regulation facilitates the implementation of the user facility reporting requirements of the Safe Medical Devices Act of 1990 (11) and adds new requirements for (12) manufacturers and user facilities, as well as requirements for written procedures, complaint files, and reporting forms.

Since the user facility has direct access to the patient and the device, it is in the best position to obtain the information that manufacturers and FDA need to determine whether the event presents a public health risk (13)

What is a device user facility?

Healthcare professionals who practice in any of the following types of clinical settings are working in a device user facility (i.e., facilities which are subject to MDR reporting):

•  Hospitals (providers of diagnostic, therapeutic, surgical, and other patient services which include general, chronic disease, rehabilitative, psychiatric, and other special‐purpose facilities)

•  Long­Term Care Facilities (providers of skilled nursing care, hospice care, or rehabilitation services)

•  Ambulatory Surgical Facilities (providers of same‐day outpatient surgical services)

•  Outpatient Treatment Facilities (providers of nonsurgical therapeutic care on an outpatient basis, which includes ambulance providers, rescue services, and home healthcare services)

•  Outpatient Diagnostic Facilities (providers of diagnostic testing on an outpatient basis, such as diagnostic radiography, mammography, ultrasonography, electrocardiography, magnetic resonance imaging, computerized axial tomography, and invitro testing services).