Medical device reporting is indivi...

Medical device reporting is individual of the US Food and remedy Administration's (FDA's) means of obtaining information onward medical device problems.(1) Congress passed the Safe Medical Devices Act of 1990 (SMDA) to strengthen the Medical Device Amendment of 1976 and to broaden the reporting criteria for device-related adverse facts (60 Fed Reg 63579 [1995]) In December 1995 the FDA issued its final regularity on medical device reporting, which clarified and expanded existing reporting requirements for medical device manufacturers and health care facilities.(2) These of the present day FDA regulations went into general intent July 31, 1996, and provide guidance to clan required to report incidents in subordination to the SMDA.

The SMDA defines the spell device as

an instrument, apparatus,

implement, machine,

contrivance, implant, in vitro

reagent, or other similar or

related article, including

ingredient part, or

accessory which is (1)

recognized in the National

Formulary, or the United

States Pharmacopeia, or

any supply to them,

(2) intended for use in the

diagnosis of disease or

other conditions, or in the

restoration mitigation, treatment,

or prevention of disease, in

man or other animals, or

(3) intended to affect the

construction of any function of

the carcass of man or other

animals, and which does

not achieve its primary

intended final cause through

chemical action within or

onward the body of man or other

animals and which is not

hanging upon being

metabolized for the

achievement of its primary

intended intent (Medical

Device Amendment of

197621 USCA [sections] 321 [h]

[West supp 19961)

A medical device, therefore, is "broadly defined to include devices ranging from gauze squeezes to implanted devices such as pacemakers."(3)

Medical devices can be categorized by means of two methods. The first course groups the devices by

* implanted devices versus nonimplanted devices,

* single-use (ie, disposable) devices versus nondisposable devices,

* diagnostic devices versus therapeutic devices,

* energy-emitting devices versus non-energy-emitting devices, and

* life-support devices versus non-life-support devices.(4)

The secondary method groups medical devices on their engineering design characteristics.

* Mechanical devices (eg wheelchairs, hip prostheses, intravenous bottle hangers, rib spreaders) function exclusively by the and of their physical structure or mechanical nature.

* Electrical devices (eg OR lamps) use electrical efficacy and passive components to achieve their functions.

* Electronic devices (eg amplifiers, electrocardiographic monitors, computers) use electrical animation and active components.

* Pneumatic devices (eg anesthesia machines, oxygen metering units, pneumatic surgical tourniquets) function within the use of gas urgency and flow.

* Hybrid devices combine sum of two units or more of the basic design natural mediums These devices might be electromechanical (eg intermittent traction machines, electric beds, electrocardiographs, suction machines) or electropneumatic (eg life-support ventilators).(5)

MEDICAL DEVICE USER FACILITY

Whenever a medical device user becomes aware of information that reasonably advises a device may have caused or contributed to the death of a patient, the user's facility must report the incident to the FDA and the device manufacturer within 10 days (SMDA, 21 USCA [sections] 360 [b] [1] [A], [West supp 1996]) The facility also must report to the manufacturer information that reasonably glance ats a device may have caused or contributed to the serious illness or serious injury to a patient (SMDA, 21 USC [sections] 360i [b] [1] [B] [West supp 19961) Device user facilities must submit semiannual reports to the FDA by dint of January 1 and July I of each year unles the facility has had no reportable medical device incidents (60 F Reg 63603 [1995]) In addition, facilities must maintain records of adverse occurrences on-site for two years, nevertheless they do not

have to retain the patient's

entire file upon hand, just

detailed information about

the end documentation of

deliberations about the

course of action taken, and

copies of forms submitted to

the FDA.(6)

Medical device user facilities are defined in this regulation as hospitals, ambulatory surgery facilities, nursing familys and outpatient diagnostic facilities in the same state [i]or[/i] condition as ambulance providers, rescue services, and fireside health care groups (60 F Reg 63598-63599 [1995]) Physicians' and other health care professionals' (eg dentists, chiropractors, optometrists, denomination nurses, employee health units) offices do not qualify as device user facilities (Id).

Medical staff members should report medical device injuries as in a short time as possible so their hospitals appropriate SMDA reporting and timing requirements. If a staff member is not indisputable whether the device caused or contributed to the injury, he or she should report the incident to the just hospital authorities who can determine whether the incident is a reportable termination Information on a reportable termination includes