ecri

Post on 31-Oct-2015

94 Views

Category:

Documents

6 Downloads

Preview:

Click to see full reader

TRANSCRIPT

■ HOW TO USE

Product CategoriesAlphabetic

When you want to find the productcategory ECRI uses to classify aparticular medical device, start in thissection. After you find the relevantproduct category(s), turn to Section B —Product Listings for a complete list ofsuppliers for each product.

TheHealth Devices SourcebookusesECRI’s Universal Medical DeviceNomenclature System™ (UMDNS™) tocategorize medical devices. UMDNS isthe international standard controlledvocabulary for medical deviceclassification used in regulatory andprocurement systems worldwide. (ECRIis a World Health Organization [WHO]Collaborating Center for InformationTransfer on Medical Devices and aparticipant in the Medical Device GlobalHarmonization Task Force.) UMDNS isone of the source vocabularies beingused to produce the Global MedicalDevice Nomenclature underdevelopment by the European standardsorganization, CEN. The nomenclaturehas been translated into many languages,is incorporated into the largestdevice-related databases in the world,and is in use in thousands of institutionsworldwide. It includes all medicaldevices and materials, as well as clinicallaboratory equipment and reagents,selected hospital furniture, casework,systems, and instruments used to testclinical equipment. The U.S. NationalLibrary of Medicine uses UMDNS toindex selected healthcare technology

assessment literature and incorporatesUMDNS concepts into its UnifiedMedical Language System (UMLS).

ECRI updates UMDNS on a daily basis.See “About theHealth DevicesSourcebook” at the front of the book forinformation on licensing UMDNS.

Following each product category is aunique five-digit Universal MedicalDevice Code (UMDC) number. You canuse these numbers to establish literaturefiling and computer-based data retrievalsystems. UMDC numbers can be usedfor computer-based inventories and onpurchase requisitions to obtainquotations from all qualified suppliers.For help in back-referencing, checkSection K — Numerical Listings,Product Categories.

“See” References: If the product nameyou’re using doesn’t match theSourcebook’s, you’ll almost certainlyfind a cross-reference indicated after“see.”

“See Also” References:Look for “seealso” references, too; you will be shownterms that may be even more appropriatefor your needs.

“Use More Specific Term”References:If your term is too general,you’ll find a number of more specificterms listed under this reference.

“Health Devices”and “ProductComparison” References:When abrand-name evaluation of a particular classof device has been published in ECRI’s

monthly journal,Health Devices, thevolume, page number, and year ofpublication are included in theSourcebook. A reference to aHealthDevicesevaluation does not imply that allof the suppliers listed for that product wereincluded in the report or that the modelsevaluated are still current. However, eachHealth Devicesevaluation includesclinical and technical backgroundinformation, guidance material, andcriteria and test methods that can beapplied to models not evaluated, even ifthe ratings cannot be used directly.

Members of the Health Devices Systemare welcome to call ECRI to determinewhether we have more currentinformation on any products. Those whodo not have the referenced issues ofHealth Devicesmay purchase them fromECRI’s circulation department. Acomplete index toHealth Devicesisavailable on request.

A reference to a “Product Comparison”for some devices indicates that adescription of that technology and achart containing suppliers’specifications for current models of thatdevice are available in one of ECRI’sHealthcare Product Comparison System(HPCS)reports. Contact ECRI’scirculation department for moreinformation onHPCSand theavailability of individual ProductComparison reports. A complete indexto HPCSis available on request.

Surgical Head Coverings [13-882]Surgical Helmet Systems [11-995] (HealthDevices 1996 25:116; Product Comparison)�see alsoBody Exhaust Systems

UMDC number References to Health Devicesevaluations and HealthcareProduct Comparison Systemreports

Cross-references to alternativeproduct categories

UMDNS controlledvocabulary term

■ HOW TO USE

Product CategoriesBy SpecialtyDevices listed in this section arearranged by major clinical specialty(and according to certain areas of thehospital). A number of devices arelisted under more than one specialty asan aid in planning and equippingspecific areas of the hospital.

TheHealth Devices SourcebookusesECRI’s Universal Medical DeviceNomenclature System™ (UMDNS™)to categorize medical devices. UMDNSis the international standard controlledvocabulary for medical deviceclassification used in regulatory andprocurement systems worldwide. (ECRIis a World Health Organization [WHO]Collaborating Center for InformationTransfer on Medical Devices and aparticipant in the Medical Device GlobalHarmonization Task Force.) UMDNS isone of the source vocabularies beingused to produce the Global MedicalDevice Nomenclature under developmentby the European standards organization,CEN. The nomenclature has beentranslated into many languages, isincorporated into the largestdevice-related databases in the world,and is in use in thousands of institutionsworldwide. It includes all medicaldevices and materials, as well as clinicallaboratory equipment and reagents,selected hospital furniture, casework,systems, and instruments used to testclinical equipment. The U.S. NationalLibrary of Medicine uses UMDNS toindex selected healthcare technologyassessment literature and incorporatesUMDNS concepts into its UnifiedMedical Language System (UMLS).

ECRI updates UMDNS on a daily basis.See “About theHealth DevicesSourcebook” at the front of the book formore information on licensing UMDNS.

Following each product category is aunique five-digit Universal MedicalDevice Code (UMDC) number. Youcan use these numbers to establishliterature filing and computer-baseddata retrieval systems. UMDC numberscan be used for computer-basedinventories and on purchase requisitionsto obtain quotations from all qualifiedsuppliers. For help in back-referencing,check Section K — Numerical Listings,Product Categories.

“Health Devices” and “ProductComparison” References:When abrand-name evaluation of a particularclass of device has been published inECRI’s monthly journal,Health Devices,the volume, page number, and year ofpublication are included in theSourcebook. A reference to aHealthDevicesevaluation does not imply that allof the suppliers listed for that productwere included in the report or that themodels evaluated are still current.However, eachHealth Devicesevaluationincludes clinical and technical backgroundinformation, guidance material, andcriteria and test methods that can beapplied to models not evaluated, even ifthe ratings cannot be used directly.

Members of the Health Devices Systemare welcome to call ECRI to determinewhether we have more currentinformation on any products. Thosewho do not have the referenced issuesof Health Devicesmay purchase themfrom ECRI’s circulation department. Acomplete index toHealth Devicesisavailable on request.

A reference to a “Product Comparison”for some devices indicates that adescription of that technology and achart containing suppliers’ specificationsfor current models of that device areavailable in one of ECRI’sHealthcare

Product Comparison System (HPCS)reports. Contact ECRI’s circulationdepartment for more information onHPCSand the availability of individualProduct Comparison reports. A completeindex toHPCSis available on request.

Devices are listed under thefollowing clinical specialties:

AnesthesiologyCardiologyCardiothoracic SurgeryClinical EngineeringClinical LaboratoryDentistryEmergency MedicineGastroenterologyGynecologyHealth FacilityHome CareImplantsIntensive Care UnitInternal MedicineMaterials ManagementNephrologyNeurologyNeurosurgeryNursing ServicesObstetricsOphthalmologyOrthopedicsOtolaryngologyPathologyPediatricsPhysical MedicineProctologyPulmonary MedicineRadiologySurgeryUrology

GastroenterologyAbsorbents, Infectious Waste [17-803]

Anastomosis Couplers, Gastrointestinal [18-135]

Anoscopes [10-156]

Aspirators, Low-Volume [10-215] (Health Devices1971-72 1:176)

Aspirators, Ultrasonic [15-756] (ProductComparison)

UMDC number

References to Health Devicesevaluations and HealthcareProduct Comparison Systemreports

UMDNS controlledvocabulary term

■ HOW TO USE

Product Listings

This section lists the manufacturers,distributors, importers, and exporters foreach product category.The Product Listings section repeatsSection A — Product Categories,Alphabetic and all its cross-references,but adds a list of suppliers and theiraddresses and phone numbers for eachcategory, along with typical equipmentprices. Toll-free telephone numbers areprovided when available.Each company is assigned a uniquesix-digit code, indicated in brackets(e.g., [102093]). To find out which ofthe companies listed are manufacturers,distributors, importers, or exporters, andto obtain more company information,turn to Section D — Manufacturers’Product Lines, and look up each supplierof interest.“See” References:If the product nameyou’re using doesn’t match theSourcebook’s, you’ll almost certainlyfind a cross-reference indicated after“see.”“See Also” References:Look for “seealso” references, too; you will be shownterms that may be even more appropriatefor your needs.“Use More Specific Term”References: If your term is too general,you’ll find a number of more specificterms listed under this reference.“Health Devices”and “ProductComparison” References:When abrand-name evaluation of a particular classof device has been published in ECRI’smonthly journal,Health Devices, thevolume, page number, and year ofpublication are included in theSourcebook. A reference to aHealth

Devicesevaluation does not imply that allof the suppliers listed for that product wereincluded in the report or that the modelsevaluated are still current. However, eachHealth Devicesevaluation includesclinical and technical backgroundinformation, guidance material, andcriteria and test methods that can beapplied to models not evaluated, even ifthe ratings cannot be used directly.

Members of the Health Devices Systemare welcome to call ECRI to determinewhether we have more currentinformation on any products. Those whodo not have the referenced issues ofHealth Devicesmay purchase them fromECRI’s circulation department. Acomplete index toHealth Devicesisavailable on request.

A reference to a “Product Comparison” forsome devices indicates that a descriptionof that technology and a chart containingsuppliers’ specifications for currentmodels of that device are available in oneof ECRI’sHealthcare ProductComparison System (HPCS)reports.Contact ECRI’s circulation department formore information onHPCSand theavailability of individual ProductComparison reports. A complete index toHPCSis available on request.

For some Product Categories, there areno United States or Canadianmanufacturers listed.These productsinclude those that represent the following:

1. Emerging technologies (e.g., thedevice may not yet have premarketapproval from the U.S. Food andDrug Administration to be sold inthe United States)

2. Obsolete technologies not currentlymarketed in the United States orCanada

3. Customized devices not currentlymarketed in the United States orCanada (e.g., devices devised andused by clinicians to solvepatient-specific clinical problems)

4. Devices that are approved or clearedfor sale in the United States but arecurrently marketed only bycompanies in countries outside theUnited States

We never list suppliers for ProductCategories that have the note “CategoryExpanded Below”; we list the suppliersof these devices under the more specificproduct listing below these categories.

Capital Equipment Pricing: We haveprovided typical prices for manycategories of capital equipment andother devices ($500 and over) for yourplanning and budgeting needs. Some ofthis information is taken from ECRI’sin-house information resources; some isprovided by suppliers. All typical pricesshould be regarded as estimates only.Wide price ranges may be due tovarying sizes of different manufacturers’systems (e.g., nurse call systems varygreatly); differences in sophistication(e.g., manual versus automaticequipment); inclusion or exclusion ofvarious options, accessories, or features;or variations in installation costs. Callsto several suppliers may be necessary toprovide better budgetary estimates;if you are a member of ECRI’sSELECT™ Program, call ECRI forbudgetary estimates.

Note: Please refer to the article “New Medical Equipment: Selection and Acquisition” at the front of the book for moreinformation on buying new medical equipment.

Anesthesia Units [10-134] (Health Devices1980 10:31; 1988 17:3; 1996 25:158; 199827:4U; Product Comparison)Typical Price: $6,200-77,950

ARMS [347236] 555 North Ln Suite 5001,Conshohocken, PA 19428; (800) 635-5080

Bell Medical [185729] 1728 Macklind Ave, StLouis, MO 63110; (800) 875-2355

UMDC number

Typical price ranges forcapital equipment

Convenient address andtelephone information forquick access

UMDNS controlledvocabulary term

■ HOW TO USE

Trade Names

When all you know is the brand name of a device and you’re not sure which suppliersells it, check this section.

The trade names are listed alphabetically followed by the name of the supplier.

When you’ve found the supplier for a trade name of interest, turn to Section D —Manufacturers’ Product Lines for complete information on that supplier.

You may find a trade name listed for more than one supplier because the same tradename can legally be registered by a number of suppliers. There may also be duplicatelistings for a trade name in instances where both a manufacturer and its exclusivedistributor claim the name or where it is listed for more than one division of acompany.

Aerofit — Thomas Fetterman Inc PerformanceCrutch Tips [108012]

Aerofix — Wescor Inc [102333]

AeroGear � Monaghan Medical Corp [103171]

AeroGrip — Porex Scientific Inc Div Porex Corp[161635]

Trade/Brand Name Supplier

Unique company number(six-digit code)

■ HOW TO USEManufacturers’ Product LinesThis section contains completeaddresses, local and toll-free telephonenumbers, fax numbers, and profiles ofmedical device manufacturers,distributors, importers, and exporters.Each company is assigned a six-digitcode, shown in brackets (e.g., [102093]).

1. World Wide Web site URLs ande-mail addresses:These locatorsare listed for Internet and othercomputerized network access tomany companies.

2. Products formerly sold under:Listed when a company’s productswere formerly sold under othercompany names because ofcompany name changes or becauseof the transfer of product line rights.

3. Company type:Companies can bedesignated as manufacturers,distributors, importers, exporters,and/or servicers. If a company leasesits equipment, this information is alsoshown. (If a company is designated asa servicer, an additional listing for thecompany will be found in SectionG — Service Company Profiles.)

4. Federal procurement eligibilityinformation: Some companies areentitled to federal procurement

privileges. These companies aredesignated as “small business,”“woman owned,” or “minorityowned.” Eligibility for VA and/orGSA contracts is also indicatedwhere applicable.

5. Methods of distributioninformation: Indicates whethersales are direct, through dealers,and/or through manufacturerrepresentatives.

6. Geographical Areas Served:Thegeographical areas to which thecompany sells.

7. Ownership type:Indicates whethera company is publicly or privatelyowned.

8. Year started:The date that thebusiness was established.

9. Quality system registration:ISO-9000 Series quality systemregistration.

10. Owned by(not shown below): Liststhe name and address of the parent/holding company where applicable.

11. Total sales:The annual sales figurefor the company.

12. Fiscal year:The beginning andending months of the fiscal year.

13. Total no. of employees:The numberof people employed at the facility.

14. No. of salespeople:The number ofsalespeople for the company. (Theremay be more salespeople than totalemployees.)

15. Contacts:List of executives and othercompany representatives with theirtitles and available e-mail addresses.

16. Subsidiaries, divisions, or affiliates(not shown below): Listed when amedical device company owns or isaffiliated with other companies thatalso sell medical devices.

17. Products:Product categories ofdevices sold asneware listed.Products listed are from ECRI’sUMDNS. See “About theHealthDevices Sourcebook” at the front ofthe book for more information onUMDNS.

Company Name Changes:Originalcompany names point to new names,which are assigned new company codes.

Parent/Holding Companies:Companiesworldwide that own or are affiliated withmedical device companies are listed,pointing you to subsidiaries, divisions, oraffiliates.

Fischer Imaging Corp [101269]12300 N Grant St, Denver, CO 80241-3120(303) 452-6800 (800) 825-8434Fax (303) 450-4335Web site: http://www.fischerimaging.comE-mail: information@fischerimaging.com

Products formerly sold under:RMS Div Fischer Imaging Corp [107152]H G Fischer Inc [109250]Machlett Div Fischer Imaging Corp [136787]Bloom Electrophysiology Div Fischer Imaging Corp

[176847]Raytheon Medical Systems Div Fischer Imaging Corp

[101631]Bloom Assoc Ltd [105642]Amrad [105263]Raytheon Nuclear Diagnostic [109306]

Company is a manufacturer, distributor, importer,and exporter

Eligible for VA and GSA contractsSells directly and through dealersGeographical Areas Served: United StatesPublicly ownedYear started: 1910Quality system registration: ISO-9001

Total sales: $78,000,000Fiscal year: January-DecemberTotal no. of employees: 500No. of salespeople: 25

CEO: Morgan Nields, Chairman of the BoardE-mail: mnields@fischerimaging.com

CFO: James Newcomb, Vice President FinanceE-mail: jnewcomb@fischerimaging.com

Mktg.: Anthony DeCarolis, Vice PresidentMarketing and SalesE-mail: adecarolis@fischerimaging.com

Human Res.: Carla Wolin, Vice President AdministrationE-mail: cwolin@fischerimaging.com

Res. & Dev.: Michael Tesic, Vice President EngineeringE-mail: mtesic@fischerimaging.com

Qual. Assur.: Samuella Emrich, Quality/RegulatoryAffairs DirectorE-mail: semrich@fischerimaging.com

Reg. Affairs: Samuella EmrichIntl. Contact: Anthony DeCarolis

Report device problems or incidents to: Samuella EmrichQuality/Regulatory Affairs Director

Cables/Leads, Other [16-316]Cameras, Radiographic Photospot [16-418]Collimators, Radiographic [16-389]

Computers, Cardiac Catheterization Laboratory [10-980]Digital Angiography Systems [16-560]

AECL Medical [101019]�see Theratronics International Ltd [107122]

Bayer AG [140715]�see subsidiaries, divisions, or affiliates:

Bayer Corp Agfa Div Technical ImagingSystems [223459]

Bayer Corp Diagnostics Div [223454]

Bayer Corp Pharmaceutical Div [223456]

Cinerex Imaging Systems Agfa Div Bayer Corp[104607]

Company Name Change:

Parent/Holding Company:

1

2

3

4

5

6

7

8

9

11

12

13

14

15

17

■ HOW TO USE

Equipment ServicesThis section allows you to look up servicecompanies by type of medical equipmentserviced, as well as by type of servicesprovided. In theHealth DevicesSourcebook,service companies aredefined as those companies whose listedmedical equipment services include someor all of the following: buys used,calibrates test equipment, leases, providesstaff (i.e., provides the services of

specialists such as respiratory therapistsor those trained in state-of-the-artequipment), repairs/maintains/tests,reconditions/rebuilds, sells parts,and sells used. Entries are arrangedby equipment category (e.g., anesthesia)and within a category by type of service(e.g., buys used). Within the type ofservice, entries are sorted by state,territory, or province and postal

code. The geographic area serviced isprovided under each company listed.

When you’ve found companies for anequipment and service type, turn toSection G — Service CompanyProfiles for complete information onthat company. For a list of maintenanceinsurance companies, see the “How toUse” page in front of Section G —Service Company Profiles.

Companies are listed under the following medical equipment categories:AmbulanceAnesthesiaCardiologyCentral SupplyClinical EngineeringClinical LaboratoryCommunicationsComputed Tomography (CT)DentalDialysisEndoscopyFacilities EngineeringGeneral Operating Room (OR)General Patient CareHome CareInfection ControlInformation SystemsInfusion TherapyLasersLithotripsyMagnetic Resonance Imaging (MRI)

MicroscopyMobile FacilitiesNeonatologyNeurologyNuclear MedicineObstetrics/GynecologyOphthalmologyOptometryOrthopedicsOtorhinolaryngologyPatient MonitoringPharmacyPhysical TherapyRadiation Therapy/OncologyRadiologyRehabilitationRespiratory/PulmonarySurgicalThermographyUltrasound

The following service types are used tolist companies:

Buys UsedCalibrates Test EquipmentLeasesProvides StaffReconditions/Rebuilds (Federally

Registered)Repairs/Maintains/TestsSells PartsSells Used

Note: Please refer to the article “Used Equipment: Buying and Selling” at the front of the book for more information onprocuring used equipment.

DialysisBuys UsedArizonaContinental Medical Exchange Corp [232277]Scottsdale, AZ 85258Service Area: Africa, Asia, Europe, South America,United States.

CaliforniaLifecare International Inc [108039]Whittier, CA 90607Service Area: Worldwide.

TS Medical Resource Systems Inc [106205]Northridge, CA 91324-3507Service Area: Canada, China, Europe, Mexico, Philippines,South America, United States: Western States.

Unitech Business Systems Medical Equipment Div [178585]Woodland Hills, CA 91367Service Area: United States.

Whittemore Enterprises [106117]Rancho Cucamonga, CA 91730-4802Service Area: Central America, Czechoslovakia, England,Mexico, Philippines, Russia, South America, United States.

Service type

State, territory, or province

Medical equipmentcategory

Geographic areas served

■ HOW TO USE

Master Company List

If you have a company in mind but are not sure where in this directory to look, checkthis section first.

Every manufacturer, distributor, importer, exporter, and service company in thisdirectory is listed here — even parent companies (companies that may not directly sellor service medical devices but that own or are affiliated with medical devicecompanies) and name changes of companies. Each company is assigned a uniquesix-digit code, indicated in brackets (e.g., [102093]). Each subsidiary, division, oraffiliate of a company is given its own listing and assigned a separate code.

You will be referred to either Section D — Manufacturers’ Product Lines and/or SectionG — Service Company Profiles for all the information you need on a particularcompany. Some companies appear in both Sections D and G because they areconsidered to be both manufacturers and service companies. See Section D —Manufacturers’ Product Lines and Section G — Service Company Profiles for detailedexplanations of the types of companies in each section.

Allina Health Systems [226272]

� Section G

Allman Products Corp [103651]

� Section D

Unique company number(six-digit code)

Reference to ServiceCompany Profiles section

Reference to Manufacturers’Product Lines section

■ HOW TO USE

Executive Contacts

When you have the name of a contact person in the medical device industry, but needto track his/her most recent affiliation, check this section. Look up names ofexecutives and other personnel by last name. This listing indicates the name of thecompany and the section of theSourcebookwhere the company can be found(Section D — Manufacturers’ Product Lines or Section G — Service CompanyProfiles). Contacts may be listed more than once if affiliated with more than onecompany or division of a company.

Contact name Company

Reference to Manufacturers’Product Lines section

Medici, Carlo � Roche Diagnostic/Boehringer

Mannheim Corp Sub J Hoffmann-La Roche & Co

AG [343455] (Section D)

Medina, Nancy B � Technology in Medicine Inc

[107491] (Section G)

Medinger, John � Organon Teknika Corp

[101258] (Sections D & G)Reference to Service CompanyProfiles section

top related