[Federal Register Volume 64, Number 146 (Friday, July 30, 1999)]
[Notices]
[Pages 41440-41441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19476]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-2098]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a document entitled ``Computer-Controlled Potentially 
High Risk Medical Devices--List of Device Types.'' 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. This 
list will be useful to FDA, manufacturers, and health care facilities 
as they prioritize and assess their efforts to prevent potential Year 
2000 (Y2K) problems with medical devices. This list has previously been 
made available on FDA's web site.

FOR FURTHER INFORMATION CONTACT: Thomas B. Shope, Center for Devices 
and Radiological Health (HFZ-140), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-3314, ext. 32.

SUPPLEMENTARY INFORMATION:

I. Background

    In order to more sharply focus agency 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. 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 noncompliant) or, if they are Y2K 
noncompliant, 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 
health care 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 any Y2K-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 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. FDA will update the list, if necessary.

II. Electronic Access

    In order to receive a copy of ``Computer-Controlled Potentially 
High Risk Medical Devices--List of Device Types'' via your fax machine, 
call the CDRH Facts-On-Demand (FOD) system

[[Page 41441]]

at 800-899-0381 or 301-827-0111 from a touch-tone telephone. At the 
first voice prompt press 1 to access DSMA Facts, at second voice prompt 
press 2, and then enter the document number (1142) followed by the 
pound sign (#). Then follow the remaining voice prompts to complete 
your request.
    Persons interested in obtaining a copy of the list may also do so 
using the World Wide Web (WWW). CDRH maintains an entry on the WWW for 
easy access to information including text, graphics, and files that may 
be downloaded to a personal computer with access to the WWW. Updated on 
a regular basis, the CDRH home page includes ``Computer-Controlled 
Potentially High Risk Medical Devices--List of Device Types,'' device 
safety alerts, Federal Register reprints, information on premarket 
submissions (including lists of approved applications and 
manufacturers' addresses), small manufacturers' assistance, information 
on video conferencing and electronic submissions, mammography matters, 
and other device-oriented information. The CDRH home page may be 
accessed at ``http://www.fda.gov/cdrh''. ``Computer-Controlled 
Potentially High Risk Medical Devices--List of Device Types'' will also 
be available at ``http://www.fda.gov/cdrh/yr2000/cdrh/phrds/
phrds.html''.

III. List of Potentially High Risk Devices

    The following list 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. 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. 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
868.1150 Indwelling Blood Carbon Dioxide Partial Pressure 
(PC02) 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 Arrhythmia 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 System 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
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 previously 
with an asterisk include radiation treatment planning systems that 
are accessories to these device types.

B. Post Medical Device Amendments Class III Devices and Devices not yet 
Classified

Automated Blood Cell and Plasma Separator for Therapeutic Purposes
Cardioconverter, Implantable
Defibrillator, Automatic Implantable Cardioverter
Defibrillator, Implantable, Dual-Chamber
Device, Thermal Ablation, Endometrial
Kit, Test, Alpha-Fetoprotein for Neural Tube Defects
Lipoprotein, Low Density, Removal
Pulse-Generator, Dual Chamber, Implantable
Pulse-Generator, Program Module
Pulse-Generator, Single Chamber
Pulse-Generator, Single Chamber, Sensor Driven, Implantable
Pump, Drug Administration, Closed Loop
Pump, Infusion, Implanted, Programmable
Separator for Therapeutic Purposes, Membrane Automated Blood Cell/
Plasma
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
System, Pacing, Temporary, Acute, Internal Atrial Defibrillation
Ventilator, High Frequency

    Dated: July 19, 1999.
 Linda S. Kahan,
 Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 99-19476 Filed 7-29-99; 8:45 am]
BILLING CODE 4160-01-F