Information Notice 1997-61, U.S Department of Health & Human Services Letter, to Medical Device Manufacturers, on Year 2000 Problem

U.S Department of Health & Human Services Letter, to Medical Device Manufacturers, on Year 2000 Problem

ML031050203
Person / Time
Site:	Beaver Valley, Millstone, Hatch, Monticello, Calvert Cliffs, Dresden, Davis Besse, Peach Bottom, Browns Ferry, Salem, Oconee, Mcguire, Nine Mile Point, Palisades, Palo Verde, Perry, Indian Point, Fermi, Kewaunee, Catawba, Harris, Wolf Creek, Saint Lucie, Point Beach, Oyster Creek, Watts Bar, Hope Creek, Grand Gulf, Cooper, Sequoyah, Byron, Pilgrim, Arkansas Nuclear, Three Mile Island, Braidwood, Susquehanna, Summer, Prairie Island, Columbia, Seabrook, Brunswick, Surry, Limerick, North Anna, Turkey Point, River Bend, Vermont Yankee, Crystal River, Haddam Neck, Ginna, Diablo Canyon, Callaway, Vogtle, Waterford, Duane Arnold, Farley, Robinson, Clinton, South Texas, San Onofre, Cook, Comanche Peak, Yankee Rowe, Maine Yankee, Quad Cities, Humboldt Bay, La Crosse, Big Rock Point, Rancho Seco, Zion, Midland, Bellefonte, Fort Calhoun, FitzPatrick, McGuire, LaSalle, Fort Saint Vrain, Shoreham, Satsop, Trojan, Atlantic Nuclear Power Plant
Issue date:	08/06/1997
From:	Cool D NRC/NMSS/IMNS
To:
References
IN-97-061, NUDOCS 9707310130
Download: ML031050203 (9)

UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

WASHINGTON, D.C. 20555 August 6, 1997 NRC INFORMATION NOTICE 97-61: U.S. DEPARTMENT OF HEALTH AND HUMAN

SERVICES LETTER, TO MEDICAL DEVICE

MANUFACTUR\ERS, ON THE YEAR 2000 PROBLEM

Addressees

All U.S. Nuclear Regulatory Commission medical licensees, veterinarians, and manufacturers/

distributors of medical devices.

Purpose

The U.S. Nuclear Regulatory Commission (NRC) is issuing this information notice to inform

licensees of a letter from the U.S. Department of Health and Human Services, Food and Drug

Administration (FDA), to medical device manufacturers, about the Year 2000 problem. It is

expected that recipients will review this information for applicability to their facilities and consider

actions, as appropriate, to avoid potential problems. However, suggestions contained in this

information notice are not NRC requirements; therefore, no specific action nor written response is

required.

Description of Circumstances

In a letter dated June 25, 1997 (attached), the FDA reminded medical device manufacturers that

some computer systems and software applications currently used in medical devices, including

embedded microprocessors, may experience problems as a result of the turn to the new century.

In addition, the letter indicated that computer-controlled design, production, or quality control

processes could be adversely affected.

Discussion

The FDA requires the manufacturers it regulates to investigate and correct problems with

medical devices that present a significant risk to public health. To ensure the continued safety

and effectiveness of medical devices, the FDA recommended that manufacturers take the

following actions: (1) ensure that medical devices submitted for premarket approval can perform

date recording and computations that will not be affected by the Year 2000 problem; (2) conduct

hazard and safety analyses on currently manufactured devices to determine whether device

performance could be affected by the Year 2000 problem, and, if so, take appropriate steps to

correct production and help customers who have purchased such devices; and (3) check design,

'4 IOU J\or qLogosp

7 7 A

Iiii II iillllIUlJl llhI1tl~

I

IN 97-61 August 6, 1997 production, and quality control processes to ensure year 2000 compliance. This letter also

applies to those manufacturers that use radioactive material in their medical devices.

If there are any questions about medical device manufacturers' responsibilities regarding the

Year 2000 problem, contact the FDA's Center for Devices and Radiological Health, Division of

Small Manufacturers Assistance, by phone, at 1-800-638-2041 or fax, at 301-443-8818. Also, an

electronic copy of the letter is available on the FDA's World Wide Web home page at

http:/lwww.fda.gov/cdrh.

Related Generic Communications

NRC Information Notice 96-70, "Year 2000 Effect on Computer System Software," issued on

December 24, 1996, addrpssed the Year 2000 problem and its applicability to NRC licensed

programs.

This information notice requires no specific action nor written response. If you have any

questions about the information in this notice, please contact the technical contact listed below or

the appropriate regional office. I

XonaId A. CoolO Dire

jvision of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Technical contact: Patricia K. Holahan, NMSS

301-415-8125 E-mail: pkh@nrc.gov

Attachments:

1. FDA Letter to Medical Device Manufacturers

2. LUst of Rece.ntly Issued NMSS Information Notices

3. List of Recentl I ed NRC Information Notices

em< as JaI

~ J

Attachment 1 IN 97-61 August 6, 1997 Public Health Service

DEPARTMENT OF HMATH & HUMAN SERVICES

Food and Drug Administration

9200 Corporate Boulevard

Rockville MD 20850

June 25, 1997 Dear Medical Device Manufacturer:

This is to remind you that some computer systems and software

applications c.urrently as"ed in medical devices, including embedded

microprocessors, may experience problems beginning January 1, 2000

due to their use ot two-digit fields for date representation. In addition

to adversely affecting the functioning of some devices, the two-digit date

format could also affect computer-controlled design, production or

quality control processes.

To ensure the continued safety and effectiveness of these devices, we

are recommending the following actions:

• For future medical device premarket submissions, manufacturers

should assure that the products can perform date recording and

computations that will be unaffected by the year-2000 date change.

• For currently manufactured medical devices, manufacturers should

conduct hazard and safety analyses to determine whether device

performance could be affected by the year-2000 date change. If

these analyses show that devite safety or effectiveness could be

affe ted, then appropriate steps should be taken to correct current

production and to assist customers who have purchased such

. devices.

For computer-controlled design. production and qualitv control

processes, manufacturers should assure that two-digit date formats

or computations do not cause problems beginning January 1, 2000.

The following information should help answer questions about

premarket submission requirements relating to year-2000 changes:

• Manufacturers need not submit Premarket Approval Application

Supplements for Class III devices to document that they have

addressed year-2000 problems, provided that the modifications

made in the device do not change other aspects of its performance.

' I

Attachment 1 IN 97-61 August 6, 1997 Manufacturers need not submit a new 510(k) (premarket

notification) for year-2000 changes to an existing device, provided

that the changes do not affect safety and effectiveness. This is in

keeping with the information provided in the Office of Device

Evaluation guidance document entitled 'Deciding When to Submit a

510(k) for a Change to an Existing Device" available from the

Division of Small Manufacturers Assistance and the FDA/CDRH

World Wide Web home page. (Note that year-2000 changes should

be included in any future 510(k) submission for a significant change

to the device.)

Manufacturers should also note that under the previous GMP

regulation and the current Quality System Regulation, effective JuDO- 1l

1997, they must investigate and correct problems with medical devices

that present a significant risk to public health. This includes devices

that fail to operate according to their specifications because of

inaccurate date recording and/or calculations. Section 518 of the Food, Drug and Cosmetic Act requires notification of users or purchasers

when a device presents an unreasonable risk of substantial harm to

public health.

If you have questions regarding these issues, please contact the CDRH

Division of Small Manufacturers Assistance by phone at 800-638-2041, or by fax at 301-443-8818. In addition, information concerning medical

device regulatory issues may be found on the CDRH home page, at

httpi/www .fda.gov/cdrh.

Sincerely yours, D. Bruce Burlington, M.D.

Director, Center for Devices and

Radiological Health

vJ

Attachment 2 IN 97-61 August 6, 1997 LIST OF RECENTLY ISSUED

NMSS INFORMATION NOTICES

Information Date of

Notice No. Subject Issuance Issued to

97-58 Mechanical Integrity of 07/31/97 Holders of and Applicants

In-Situ Leach Injection for Licenses for In-Situ

Wells and Piping Leach Facilities

97-57 Leak Testing of Packaging 07/30197 Suppliers and users of

Used in the Transport of packaging for the trans- Radioactive Material portation of radioactive

material required to per- form packaging leak tests

97-56 Possession Limits for 07/28/97 All licensees authorized

Special Nuclear Material to possess special nuclear

at the Environcare of material

Utah Low-Level Radioactive

Waste Disposal Facility

97-55 Calculation of Surface 07/23/97 All Uranium Recovery

Activity for Contaminated Licensees

Equipment and Materials

97-51 Problems Experienced 07/11/97 All holders of OLs or CPs

with Loading and for nuclear power reactors

Unloading Spent Nuclear

Fuel Storage and Trans- Designers and fabricators

portation Casks of independent spent fuel

storage installations

All holders of or applicants

for licenses to operate ISFSls

97-50 Contaminated Lead 07/10/97 All U.S. Nuclear Regulatory

Products Commission licensees

97-47 Inadequate Puncture 06/27/97 All "users and fabricators"

Tests for Type B of type B transportation

Packages Under 10 CFR packages [as defined in

71.73(c)(3) 10 CFR 171.16(10(B)]

K> vK

Attachment 3 IN 97-61 August 6, 1997 LIST OF RECENTLY ISSUED

NRC INFORMATION NOTICES

Information Date of

Notice No. Subject Issuance Issued to

97-60 Incorrect Unreviewed 08/01/97 All holders of OLs or CPs

Safety Question Deter- for pressurized-water

mination Related to reactors

Emergern_.- Core Cooling

System Swapover from

the Injection Mode to

the Recirculation Mode

97-59 Fire Endurance Test 08/01/97 All holders of OLs or CPs

Results of Versawrap for nuclear power reactors

Fire Barriers

97-58 Mechanical Integrity of 07/31/97 Holders of and Applicants

In-Situ Leach Injection for Licenses for In-Situ

Wells and Piping Leach Facilities

97-57 Leak Testing of Packaging 07/30/97 Suppliers and users of

Used in the Transport of packaging for the trans- Radioactive Material portation of radioactive

material required to per- form packaging leak tests

97-56 Possession Limits for 07/28/97 All licensees authorized

Special Nuclear Material to possess special nuclear

at the Environcare of material

Utah Low-Level Radioactive

Waste Disposal Facility

97-55 Calculation of Surface 07/23/97 All Uranium Recovery

Activity for Contaminated Licensees

Equipment and Materials

OL = Operating License

CP = Construction Permit

IN 97-61 August 6, 1997 production, and quality control processes to ensure year 2000 compliance. This letter also

applies to those manufacturers that use radioactive material in their medical devices.

If there are any questions about medical device manufacturers' responsibilities regarding the

Year 2000 problem, contact the FDA's Center for Devices and Radiological Health, Division of

Small Manufacturers Assistance, by phone, at 1-800-638-2041 or fax, at 301-443-8818. Also, an

electronic copy of the letter is available on the FDA's World Wide Web home page at

http://www.fda.govlcdrh.

Related Generic Communications

NRC Information Notice 96-70, "Year 2000 Effect on Computer System Software," issued on

December 24, 1996, addressed the Year 2000 problem and its applicability to NRC licensed

programs.

This information notice requires no specific action nor written response. If you have any

questions about the information in this notice, please contact the technical contact listed below or

the appropriate regional office.

Donald A. Cool, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Technical contact: Patricia K Holahan, NMSS

301-415-8125 E-mail: pkh@nrc.gov

Attachments:

1. FDA Letter to Medical Device Manufacturers

2. List of Recently Issued NMSS Information Notices

3. List of Recently Issued NRC Information Notices

DOCUMENT NAME: 97-61._N *SEE PREVIOUS CONCURRENCE

OFC IMOB I Tech Editor _ IMOB I IMAB I IMNS Z

NAME MASitek* EKraus* JMPiccone* LWCamper* DACool*

DATE j 7/111/97 [ 7/11/97 7/16/97 1 7/19/97 7/25/97 J

OFFICIAL RECORD COPY

IN 97-XX

July XX, 1997 If there are any questions about medical device manufacturers responsibilities regarding the

Year 2000 problem, contact the FDA's Center for Devices and Radiological Health, Division of

Small Manufacturers Assistance, by phone, at 1-800-638-2041 or fax, at (301) 443-8818. Also, an electronic copy of the letter is available on the FDA's World Wide Web home page at

http:/twww.fda.gov/cdrh.

Related Generic Communications

NRC Information Notice 96-70, "Year 2000 Effect on Computer System Software," issued on

December 24, 1996, addressed the Year 2000 problem and its applicability to NRC licensed

programs.

This information notice requires no specific action nor written response. If you have any

questions about the information in this notice, please contact the technical contact listed below

or the appropriate regional office.

Donald A. Cool, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Technical contact: Patricia K. Holahan, NMSS/IMNS

301-415-8125 e-mail: pkh@nrc.gov

Attachments:

1. FDA Letter to Medical Device Manufacturers

2. List of Recently Issued NMSS Information Notices

3. List of Recently Issued NRC Information Notices

DOCUMENT NAME: imns5850.mas *SEE PREVIOUS CONCURFENCE

[ OFC IMOB I Tech Editor lI IMOB I IMAB WO 417 \

NAME MASitek* EKraus* JMPiccone* LWCamper _ 1 l DATE 7/11/97 7/11/97 7/16/97 71 1797 _____

q )OFFICIAL RECORD COPY

• *IN 97-XX

July XX, 1997 If there are any questions about medical device manufacturers' responsibilities regarding the

Year 2000 problem, contact the FDA's Center for Devices and Radiological Health, Division of

Small Manufacturers Assistance, by phone, at 1-800-638-2041 or by fax, at 301-443-8818. Also, an electronic copy of the letter is available on the FDA's World Wide Web home page at

http:/lwww.fda.gov/cdrh.

Related Generic Communications:

NRC Information Notice 96-70, uYear 2000 Effect on Computer System Software,' issued on

December 24, 1996, addressed the Year 2000 problem and its applicability to NRC licensed

programs.

This information notice requires no specific action nor written res se. If you have any

questions about the information in this notice, please contact technical contact listed below or

the appropriate regional office.

Donald A. Cool, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

/ and Safeguards

Technical contact: Patricia K Hoolahan, NMSS/IMNS

301-415-8125 e-mail: ,pkh@nrc.gov

Attachments: //

1. FDA Letter to Mqdical Device Manufacturers

2. List of Recently Issued NMSS Information Notices

3. List of Recenfly Issued NRC Information Notices

DOCUMENT NAME: imns5850.mas *SEE PREVIOUS CONCURRENCE

OFC )0B l Tech Editor MBAI[ jlii IMAB IMNS I

NAME MA ~k EKraus* Jlccone LWCamper DACool

DATE 71/1(97 7/11/97 7I/1/97 7/ 197 71 /97 OFFICIAL RECORD COPY