Center for Devices and Radiological Health

**Food and Drug Administration**

**Computer-Controlled Potentially High-Risk Medical Devices -- List of
Device Types**

In order to more sharply focus our efforts related to the possible
impact of the Y2K date problem on medical devices, FDA has developed a
list of types of computer-controlled, potentially high-risk medical
devices that have the potential for the most serious consequences for
the patient should they fail because of date-related problems. Inclusion
of a type of device on this list does not mean that all devices of this
type have a date-related problem (are Y2K non-compliant) or, if they are
Y2K non-compliant, that they necessarily pose a significant risk to
patients. Rather, this list includes those types of devices that could
pose a risk to patients if the date-related failure affects the function
or operation of the device. FDA will use this list to identify those
devices (and manufacturers) that would present the most serious risks to
patients if they experienced a Y2K related failure. This will help the
agency to focus attention on the devices that could present the highest
levels of risk.

The list includes the types of computer-controlled devices whose failure
to function as designed or expected could result in immediate and
serious adverse health consequences. These potentially high-risk devices
are those that are:

> 1\) Used in the direct treatment of a patient where device failure
> could compromise the treatment or could injure the patient, or

2\) Used in the monitoring of vital patient parameters and whose data
are immediately necessary for effective treatment, or

> 3\) Necessary to support or sustain life during treatment or patient
> care.

The list does not include diagnostic devices whose failure would not
result in immediate harm to the patient, even though the diagnostic
information they provide might be unavailable or incorrect. However, a
few diagnostic devices have been included, if the results of
calculations or other information processing by the device would not be
readily apparent to the user, and a Y2K failure of the device could
reasonably lead to serious adverse health consequences before being
detected by the user.

This list of computer-controlled potentially high-risk devices will be
used by FDA for several purposes and can also provide a guide to
healthcare facilities regarding the types of devices that should receive
priority in their assessment and remediation of medical devices.

FDA will identify all manufacturers of these types of devices. These
manufacturers will be candidates for further oversight to provide
increased assurance that product Y2K status has been carefully assessed
and that anyY2K-related upgrade has been developed and tested in
accordance with the quality system regulations. That oversight may
include facility inspection or audit. FDA will also ascertain whether
these manufacturers have made Y2K status information available to users,
and that, where appropriate, users have received notification regarding
any necessary remedial action that may be necessary.

This list should not be considered a definitive list of all high-risk
devices. It was developed by FDA staff based on their assessment of the
types of devices that have the greatest potential for direct patient
risk should they fail to correctly process date-related information. The
list may change as FDA receives comments on the types of devices
included in the list.

FDA solicits comments from healthcare facilities, manufacturers and
others regarding the device types included or omitted from this list.
Any person wishing to suggest additions to or deletions from this list
should provide that information and the rationale for the suggestion.
These suggestions should be sent to the following address and should be
received by July 15, 1999.

Year 2000 Coordinator (HFZ-140)

Center for Devices and Radiological Health

9200 Corporate Boulevard

Rockville, MD 20850

FAX 301-443-9101

The list below contains the potentially high-risk device types. Where
the generic device type has been classified by FDA, the list includes
the section number [in Title 21 of the Code of Federal Regulations where
the device type is
described](http://www.fda.gov/cdrh/yr2000/classification.html). For
those devices cleared for market through the Premarket Approval
application process or which have not yet been classified, no
classification regulation number is given.

A link is also provided to the [Federal Y2K Biomedical Equipment
Clearinghouse
Search](http://www.fda.gov/scripts/cdrh/year2000/y2k_search.cfm)
mechanism to determine the compliance status of medical devices, as
reported by the device manufacturers. As an additional aid, a link is
provided to the [Manufacturer Registration
Database](http://www.fda.gov/scripts/cdrh/cfdocs/cfrl/registra/search.cfm),
which contains names and addresses of manufacturers who have registered
with the FDA.

**CLASSIFIED DEVICES**

(Classification regulation number followed by classification name)

862.1345 GLUCOSE TEST SYSTEM

862.2140 CENTRIFUGAL CHEMISTRY ANALYZER FOR CLINICAL USE

862.2150 CONTINUOUS FLOW SEQUENTIAL MULTIPLE CHEMISTRY ANALYZER FOR
CLINICAL USE

862.2160 DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE

862.2170 MICRO CHEMISTRY ANALYZER FOR CLINICAL USE

864.9145 PROCESSING SYSTEM FOR FROZEN BLOOD

864.9175 AUTOMATED BLOOD GROUPING AND ANTIBODY TEST SYSTEM

864.9205 BLOOD AND PLASMA WARMING DEVICE

864.9575 ENVIRONMENTAL CHAMBER FOR STORAGE OF PLATELET CONCENTRATE

864.9700 BLOOD STORAGE REFRIGERATOR AND BLOOD STORAGE FREEZER

868.1150 INDWELLING BLOOD CARBON DIOXIDE PARTIAL PRESSURE (PCO2)
ANALYZER

868.1200 INDWELLING BLOOD OXYGEN PARTIAL PRESSURE (P02) ANALYZER

868.1730 OXYGEN-UPTAKE COMPUTER

868.2375 BREATHING FREQUENCY MONITOR

868.2450 LUNG WATER MONITOR

868.5160 GAS MACHINE FOR ANESTHESIA OR ANALGESIA

868.5330 BREATHING GAS MIXER

868.5400 ELECTROANESTHESIA APPARATUS

868.5440 PORTABLE OXYGEN GENERATOR

868.5470 HYPERBARIC CHAMBER

868.5610 MEMBRANE LUNG (FOR LONG TERM PULMONARY SUPPORT)

868.5830 AUTOTRANSFUSION APPARATUS

868.5880 ANESTHETIC VAPORIZER

868.5895 CONTINUOUS VENTILATOR

868.5925 POWERED EMERGENCY VENTILATOR

868.5935 EXTERNAL NEGATIVE PRESSURE VENTILATOR

868.5955 INTERMITTENT MANDATORY VENTILATION ATTACHMENT

870.1025 ARRYTHMIA DETECTOR AND ALARM

870.1750 EXTERNAL PROGRAMMABLE PACEMAKER PULSE GENERATOR

870.3535 INTRA-AORTIC BALLOON AND CONTROL SYSTEM

870.3545 VENTRICULAR BYPASS (ASSIST) DEVICE

870.3600 EXTERNAL PACEMAKER PULSE GENERATOR

870.3610 IMPLANTABLE PACEMAKER PULSE-GENERATOR

870.3700 PACEMAKER PROGRAMMERS

870.4220 CARDIOPULMONARY BYPASS HEART-LUNG MACHINE CONSOLE

870.4320 CARDIOPULMONARY BYPASS PULSATILE FLOW GENERATOR

870.4330 CARDIOPULMONARY BYPASS ON-LINE BLOOD GAS MONITOR

870.4360 NONROLLER-TYPE CARDIOPULMONARY BYPASS BLOOD PUMP

870.4370 ROLLER TYPE CARDIOPULMONARY BYPASS BLOOD PUMP

870.4380 CARDIOPULMONARY BYPASS PUMP SPEED CONTROL

870.5225 EXTERNAL COUNTER-PULSATING DEVICE

870.5300 DC-DEFIBRILLATOR LOW ENERGY (INCLUDING PADDLES)

876.5270 IMPLANTED ELECTRICAL URINARY CONTINENCE DEVICE

876.5630 PERITONEAL DIALYSIS SYSTEM AND ACCESSORIES

876.5820 HEMODIALYSIS SYSTEMS AND ACCESSORIES

876.5860 HIGH PERMEABILITY HEMODIALYSIS SYSTEM

876.5870 SORBENT HEMOPERFUSION SYSTEM

876.5880 ISOLATED KIDNEY PERFUSION AND TRANSPORT SYSTEM AND ACCESSORIES

880.5130 INFANT RADIANT WARMER

880.5400 NEONATAL INCUBATOR

880.5410 NEONATAL TRANSPORT INCUBATOR

880.5725 INFUSION PUMP

882.5820 IMPLANTED CEREBELLAR STIMULATOR

882.5830 IMPLANTED DIAPHRAGMATIC/PHRENIC NERVE STIMULATOR

882.5840 IMPLANTED INTRACEREBRAL/SUBCORTICAL STIMULATOR FOR PAIN RELIEF

882.5850 IMPLANTED SPINAL CORD STIMULATOR FOR BLADDER EVACUATION

882.5860 IMPLANTED NEUROMUSCULAR STIMULATOR

882.5870 IMPLANTED PERIPHERAL NERVE STIMULATOR FOR PAIN RELIEF

882.5880 IMPLANTED SPINAL CORD STIMULATOR FOR PAIN RELIEF

884.1700 HYSTEROSCOPIC INSUFFLATOR

884.1730 LAPAROSCOPIC INSUFFLATOR

884.2660 FETAL ULTRASONIC MONITOR AND ACCESSORIES

*^\*^ The following device classifications include radiation treatment
planning systems which are accessories to these device types.*

892.5050^\*^ MEDICAL CHARGED-PARTICLE RADIATION THERAPY SYSTEM^\*^

892.5300^\*^ MEDICAL NEUTRON RADIATION THERAPY SYSTEM^\*^

892.5700^\*^ REMOTE CONTROLLED RADIONUCLIDE-APPLICATOR SYSTEM^\*^

892.5750^\*^ RADIONUCLIDE RADIATION THERAPY SYSTEM^\*^

892.5900^\*^ X-RAY RADIATION THERAPY SYSTEM^\*^

*^\*^ The device classifications specified above, flagged with an
asterisk, include radiation treatment planning systems which are
accessories to these device types.*

**POST-MEDICAL DEVICE AMENDMENTS CLASS III DEVICES, AND DEVICES NOT YET
CLASSIFIED**

VENTILATOR, HIGH FREQUENCY

CARDIOCONVERTER, IMPLANTABLE

DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

PULSE-GENERATOR, PROGRAM MODULE

PULSE-GENERATOR, SINGLE CHAMBER, SENSOR DRIVEN, IMPLANTABLE

PULSE-GENERATOR, SINGLE CHAMBER

SYSTEM, PACING, TEMPORARY, ACUTE, INTERNAL ATRIAL DEFIBRILLATION

AUTOMATED BLOOD CELL AND PLASMA SEPARATOR FOR THERAPEUTIC PURPOSES

LIPOPROTEIN, LOW DENSITY, REMOVAL

SEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA

PUMP, DRUG ADMINISTRATION, CLOSED LOOP

PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

STIMULATOR, CORTICAL, IMPLANTED (FOR PAIN)

STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

STIMULATOR, SACRAL NERVE, IMPLANTED

STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

STIMULATOR, SUBCORTICAL, IMPLANTED FOR EPILEPSY

DEVICE, THERMAL ABLATION, ENDOMETRIAL

INSTRUMENTS USED TO SCREEN THE BLOOD SUPPLY FOR BLOODBORNE PATHOGENS

SOFTWARE, BLOOD BANK, STAND ALONE PRODUCTS