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198
Health Devices Alerts®

Last Loaded on Web: Wednesday, May 01, 2013

Last Update To Bluesheet: August 18, 2008

Bluesheet Contents     PDF version

File Description Print Counterparts Geographic Coverage Terms and Conditions Limit Rates
Subject Coverage Dialog File Data Special Features Sample Record Sort
Sources Database Content DIALINDEX/OneSearch Categories Basic Index Rank
Tips Document Types Indexed Contact Additional Indexes Predefined Format Options


File Description [top]

Health Devices Alerts® (HDA), produced by ECRI, is a comprehensive database of reported medical device problems, hazards, recalls, evaluations, and updates. The selections derive from an extensive review of the medical, legal, and technical literature, various national reporting networks and government sources, and ECRI'S own international problem reporting network. Each entry is indexed using ECRI's internationally endorsed Universal Medical Device Nomenclature System (UMDNS). An online thesaurus is available to assist in locating broader, narrower, and related product names. A complete directory of medical devices and manufacturers is available in a companion database, File 188, ECRI's Health Devices Sourcebook®.

HDA covers reports of problems, evaluations, and technology assessments of diagnostic and therapeutic medical equipment and related materials, ranging from sutures to magnetic resonance imaging units, including implanted devices and related accessories, disposable medical products, clinical laboratory reagents, and selected hospital furniture, casework, and systems.



Tips [top]

USE FILE 198

to track medical device problems, hazards, recalls, evaluations, and updates.

USE /CO OR CO=

to find companies of interest.

USE /PN OR PN=

to find product names of interest.



Subject Coverage [top]

HDA covers reports of problems with diagnostic and therapeutic medical equipment and related materials, including:

  • Radiological Devices
  • Implanted Devices and Related Accessories
  • Disposable Medical Products
  • Clinical Laboratory Reagents
  • Product Misuse
  • Hospital Furniture
  • Ophthalmologic Devices
  • Obstetric/Gynecologic Devices
  • Dental Equipment
  • Surgical Equipment
  • Materials Management Products
  • Orthopedic Devices
  • Physical Medicine Equipment


Sources [top]

HDA contains four major types of information relating to medical devices: 1) abstracts (ABS) of articles from the published literature, 2) action items (AI) that ECRI has investigated or verified, 3) Problem Reporting Program (PRP) records from the voluntary, spontaneous reporting system operated by the U.S. Food and Drug Administration (FDA), and 4) Medical Device Reporting (MDR) records from the mandatory reporting system operated by the FDA.



Print Counterparts [top]

  • None


Dialog File Data [top]

Dates Covered: 1977 to 2000 (Abstracts); 1982 to 2000 (AI); 1984 to 1996 (MDR); 1977 to 1992 (PRP)
File Size: More than 683,000 records
Update Frequency: Closed


Database Content [top]

  • Bibliographic Records


Document Types Indexed [top]

  • Reports
  • Journal Articles


Geographic Coverage [top]

  • US Only


Geographic Restrictions [top]

  • None


Special Features [top]

  • ERA Available
  • Graduate Education Program
  • KWIC and HILIGHT Available
  • DIALOG Alert Available
  • Online Thesaurus for product names


DialIndex/OneSearch Categories [top]

ACRONYM CATEGORY NAME
MEDDEV Medical Devices
MEDENG Medical Engineering
PRODINFO Product Information
PRODUCTS Industrial and Consumer
REGS Regulations


Contact [top]

Health Devices Alerts is produced by ECRI, an independent, non-profit agency that evaluates health care technologies. Questions concerning file content should be directed to:

ECRI
5200 Butler Pike
Plymouth Meeting, PA 19462

Telephone: 610-825-6000
Fax: 610-834-1275


Terms and Conditions [top]

Health Devices Alerts is a registered trademark of ECRI

For Dialog's Redistribution and Archive Policy, enter HELP ERA online. The following terms and conditions also apply.

Health Devices Alerts and the medical device terms and numerical codes used therein are owned and copyrighted by ECRI. ECRI authorizes the use of such terms and codes solely for the customer's internal use. All bibliographic information and record identification information in Health Devices Alerts are owned and copyrighted by ECRI. Health Devices Alerts may not be disseminated, reproduced, or in any way made available to any third party or be used for any commercial purpose whatsoever without the prior written consent of ECRI. Requests for permission should be addressed to: Permissions Editor, ECRI, 5200 Butler Pike, Plymouth Meeting, PA 19462.

ECRI MAKES NO WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE ACCURACY, QUALITY, VALIDITY, OR COMPLETENESS OF THIS DATABASE OR THE INFORMATION THEREIN. In no event shall ECRI be liable for any lost profits, or indirect or consequential damages and in no event shall ECRI's liability exceed the cost of the online database search charge for the specific information giving rise to such liability. Listing a specific model and brand of device does not in itself justify deferring a purchase or taking equipment out of service without further investigation, nor does it imply that competing devices are safer or more appropriate. Although each MDR report reflects an actual incident, readers are urged to use the information with caution. The cause of an injury or death may not have been established, and the presence of a report in this database does not reflect a judgment by the manufacturer, the FDA, or ECRI that a device defect exists or that the device was responsible for the reported death or injury.


Dialog Standard Terms & Conditions apply.


SAMPLE RECORD [top]

ECRI ABSTRACT RECORD

     File 198:Health Devices Alerts(R) 
     (c) 1997 ECRI-nonprft agncy 
     
  AN=, SF=   00027683    ABS-15894; AI-A1333    SUBFILE: ABS 
  PC=, /PN, PN=   PRODUCT(s):13-209 PUMPS, ENTERAL FEEDING 
  /DE   COMMON DEVICE NAME:  Kangaroo 220 and 330 Enteral Feeding Pumps 
  /ID   IDENTIFIER:  Pumps manufactured prior to June 1985 
     
  /CO, CO=   MANUFACTURER:  Sherwood Medical Co. Sub American Home Products 
        (101927), 1831 Olive St, St Louis Mo 63103 
     
  /TX   ECRI recently  received a report  involving  overinfusion  associated 
     with a Kangaroo  330  Enteral  Feeding Pump.  Over infusion  resulted 
     when  the pump  set was incorrectly  installed behind the rotor.   To 
     help prevent incorrect  installation,  Sherwood Medical  modified the 
     rotors on the Kangaroo 220 and 330  pumps.   In  June 1985,  Sherwood 
     Medical  informed   ECRI  that  it  will  exchange  rotors  on  pumps 
     manufactured  prior  to  June  1985  for  the  modified ones, free of 
     charge.  (Rotors manufactured  prior to June 1985 are metal;  the new 
     rotors are plastic.)   It emphasizes  that most  situations involving 
     overinfusion result from user error and can be  avoided by  following 
     the instructions for correct placement of the set on the rotor. These 
     directions appear in the pump's operating manual,  on the pump itself 
     and on the pump set.  Hospitals  should  ensure  that  all users  are 
     familiar  with  proper assembly and follow user  instructions for the 
     Kangaroo 220 and 330 Enteral Feeding Pumps. To help prevent incorrect 
     installation of the pump set,  replace all old metal  rotors  in your 
     Kangaroo  220  and  330  pumps  with  the  modified ones.   To  order 
     replacement rotors or for more information, contact  Sherwood Medical 
     Customer  Service,  Watertown,  NY,  at  (800) 448-0190: in New York, 
     (315) 788-0300. 
     
  SO=   SOURCE:  ECRI, Manufacturer 
  PD=   PUBLICATION DATE:  8905 

MEDICAL DEVICE REPORTS RECORD

     File 198:Health Devices Alerts(R) 
     (c) 1997 ECRI-nonprft agncy 
     
  AN=, SF=   00027825    MDR-157579   SUBFILE: MDR 
  PC=, /PN, PN=   PRODUCT(s):  10-727 CATHETERS, INTRAVENOUS, PERIPHERAL 
  /DE   COMMON DEVICE NAME:  SUBCLAVIAN JUGULAR CATHETER SET 
  /ID   IDENTIFIER:  MODEL NA CATALOG 38-755-1 
     
  /CO, CO=   MANUFACTURER:  Deseret Medical, Inc. 
     
  /TX   DURING  ATTEMPTED  PLACEMENT  OF  16  GAUGE 12 IN CV CATHETER IN LEFT 
     SUBCLAVIAN  FOR  ADMINISTRATION OF TPN,  THE  TIP PORTION OF CATHETER 
     FRACTURED  OFF  PT TAKENTO OR THE  EMBOLIZED  CATHETER  FRAGMENT  WAS 
     REMOVED.   APPARENTLY  THE CATHETER PORTION  WAS  DISCARDED AFTER THE 
     CATHETER  PORTION WAS DISCARDED  AFTER  EVENT.  CO'S  DIRECTIONS  FOR 
     CAUTION  AGAINST  WITHDRAWING   CATHETER  AGAINST   NEEDLE  BEVEL AS, 
     CATHETER  MAY  BE CUT,  SEE  DIRECTIONS  FOR  USE AS  PACKAGED   WITH 
     INDIVIDUAL SUBCLAVIAN CATHETER AND ALSO PRESENT ON A 8 x 10  SHEET IN 
     EACH BOX OF PRODUCT. 
     
  SO=   SOURCE:  M.D.R. REPORT DATED 9/02/88 
  /TX   ECRI COMMENT:  This user error is reported virtually every month. 
  FP=   FDA PRODUCT CODE:  DQO 
     MANUFACTURER DISCLAIMER:  THIS INFORMATION IS SUBMITTED PURSUANT TO 21 
        CFR 803. DESERET MEDICAL DOES  NOT  CONSIDER  THIS  REPORT  OR  ITS 
        CONTENTS TO  BE AN ADMISSION THAT A DESERET PRODUCT IS DEFECTIVE OR 
        THAT A DESERET PRODUCT HAS CAUSED A DEATH OR SERIOUS INJURY. 


BASIC INDEX [top]

SEARCH
SUFFIX
DISPLAY
CODE
FIELD NAME
INDEXING
SELECT EXAMPLES
None None All Basic Index Fields Word S CATHETERS(W)CENTRAL(W)VENOUS
/CO CO Company Name1 Word S SHERWOOD(W)MEDICAL/CO
/DE DE Common Device Name Word S KANGAROO(W)220/DE
/ID ID Identifier Word S PUMPS(F)1985/ID
/PN PN Product Name1 Word
& Phrase
S CATHETERS(W)CENTRAL(W)VENOUS/PN
S PUMPS, ENTERAL FEEDING/PN
/TX TX Abstract, Problem, Action Needed, Comments Word S (OVERINFUSION AND KANGAROO)/TX

1 Searchable in the Basic Index and in the Additional Indexes.


ADDITIONAL INDEXES [top]

SEARCH
PREFIX
DISPLAY
CODE
FIELD NAME
INDEXING
SELECT EXAMPLES
None AN DIALOG Accession Number
AN= AN ECRI Accession Number Phrase S AN=ABS-15894
S AN=AI-A1333
CO= CO Company Name1 Word S CO=(BECTON(W)DICKINSON)
None DS Manufacturer Disclaimer
ET= ET Effect Type3 Phrase S ET=SERIOUS INJURY
FP= FP FDA Product Code Phrase S FP=DQO
PC= PC Product Code2 Phrase S PC=13-209
PD= PD Publication Date of Record Entry Phrase S PD=198905
PN= PN Product Name1 Word
& Phrase
S PN=(CATHETERS(W)CENTRAL(W)VENOUS)
S PN=PUMPS, ENTERAL FEEDING
None RF ECRI Reference Accession Number
SF= SF Subfile5,6 Phrase S SF=MDR
SO= SO Source Information4 Word S SO=(ECRI(W)MANUFACTURER)
UD= None Update7 Phrase S UD=9999

2 Product codes are assigned to specific medical devices. When no product codes exist for very broad classifications of medical devices, PC=00-000 is assigned.

3 Available only in MDR subfile.

4 Display includes Journal Name, Volume, Pagination, and Publication Date.

5 MDR is available only in 1984-1996.

6 PRP is available only in 1977-1992.

7 UD index is present only from UD=199909 forward.


LIMIT [top]

SUFFIX FIELD NAME EXAMPLES
/ABS Abstract Present SELECT S2/ABS
/AI Action Items Records SELECT S3/AI
/MDR Medical Device Reports Records5 SELECT S2/MDR
/PRP Product Review Problems Records6 SELECT S3/PRP


SORT [top]

SORTABLE FIELDS EXAMPLES
CO, PD, PN, SF SORT S6/ALL/CO
PRINT S3/5/1-24/SF


RANK [top]

RANK FIELDS EXAMPLES
All phrase- and numeric-indexed fields in the Additional Indexes can be ranked. RANK ET
RANK PN S4


USER-DEFINED FORMAT OPTIONS [top]

Display codes listed in the Search Options tables can be used to customize output. TYPE S3/PC,PN,CO,DE/1-5


PREDEFINED FORMAT OPTIONS [top]

NO.
DIALOGWEB
FORMAT
RECORD CONTENT
1 -- DIALOG Accession Number
2 -- Accession Numbers, Subfile,Product Name and Product Code, Common Device Name, Identifier, Company Information, Source, Publication Date, Effect Type, ECRI Comment, FDA Product Code, Manufacturer Disclaimer
3 Medium Accession Numbers, Subfile, Product Name and Product Code, Source
4 -- Full Record with Tagged Fields
5 -- Full Record
6 Free Accession Numbers, Subfile, Product Name and Product Code, and Common Device Name
7 Long Accession Numbers, Subfile, Product Name and Product Code, and Abstract
8 Short Accession Numbers, Subfile, Product Name and Product Code, Publication Date, and Effect Type
9 Full Full Record
K -- KWIC (Key Word In Context) displays a window of text; may be used alone or with other formats


DIRECT RECORD ACCESS [top]

FIELD NAME EXAMPLES
If the accession number of a specific record is known, it can be used to display the record directly. TYPE 00027683/5
DISPLAY 00027825/CO,DE
PRINT 00027933/2


Rates [top]

Rates For File: Health Devices Alerts®[198]

                                Standard  Subscrib
Cost per DialUnit:                 $6.89     $6.36
Cost per Minute:                   $2.02     $1.85
Rank Elements                      $0.00     $0.00

        <<  Standard  >>  << Subscriber >>
Format    Types   Prints    Types   Prints
     1    $0.00    $0.00    $0.00    $0.00
     2    $5.00    $5.00    $2.20    $2.20
     3    $2.00    $2.00    $1.10    $1.10
     4    $5.00    $5.00    $2.20    $2.20
     5    $5.00    $5.00    $2.20    $2.20
     6    $0.00    $0.00    $0.00    $0.00
     7    $4.00    $4.00    $1.10    $1.10
     8    $0.00    $0.00    $0.00    $0.00
     9    $5.00    $5.00    $2.25    $2.25
KWIC95    $0.40       NA    $0.00       NA
KWIC96    $0.40       NA    $0.00       NA

REDIST/COPY Multiplier Table:
      Range      Multiplier
        1-2       1.00
       3-25       1.50
     26-100       3.00
    101-200       4.00
    201-500       6.00
   501-1000       8.00
 1001 or more    10.00

ARCHIVE Multiplier Table:

      Range      Multiplier
       1-25       1.50
     26-200       3.00
    201-500       6.00
   501-1000       8.00
 1001 or more    10.00
[top]



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