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Start Over Subjects Equipment Safety ✖Remove constraint Subjects: Equipment Safety

2. How wet is your patient's bed?: blood, urine, and microbiological contamination of mattresses and mattress covers

Author(s):
Sivek, Amanda, author
Davis, James, author
Publication:
[Harrisburg, Pa.] : Pennsylvania Patient Safety Authority, December 2018
Subject(s):
Bedding and Linens -- adverse effects
Beds -- adverse effects
Body Fluids
Equipment Contamination
Equipment Safety
Bedding and Linens -- microbiology
Beds -- microbiology
Cross Infection -- prevention & control
Equipment Failure
Infection Control
Maintenance
Patient Safety
Humans
Pennsylvania
United States

3. Venous air emboli and automatic contrast media injectors

Publication:
[Harrisburg, Pa.] : Pennsylvania Patient Safety Authority, December 2004
Subject(s):
Contrast Media
Embolism, Air -- etiology
Embolism, Air -- prevention & control
Injections, Intravenous -- adverse effects
Injections, Intra-Arterial -- adverse effects
Injections, Intravenous -- instrumentation
Injections, Intra-Arterial -- instrumentation
Equipment Safety
Medical Errors -- prevention & control
Patient Safety
Tomography, X-Ray Computed
Humans
Pennsylvania
United States

6. Health care without the doctor: how new devices and technologies aid clinicians and consumers

Publication:
Oakland, Calif. : California HealthCare Foundation, c2009
Subject(s):
Decision Making, Computer-Assisted
Decision Support Techniques
Delivery of Health Care -- methods
Home Nursing
Internet
Patient Participation
Point-of-Care Systems
Reagent Kits, Diagnostic
Self Care
Allied Health Personnel
Ambulatory Care Facilities
Community Participation
Device Approval
Equipment Safety
Evidence-Based Medicine
Federal Government
Government Regulation
Health Care Sector
Health Policy
Insurance, Health, Reimbursement
Patient Advocacy
Privacy
State Government
Treatment Outcome
Humans
Diagnosis, Computer-Assisted
California

7. Spotlight on electronic health record errors: errors related to the use of default values

Author(s):
Sparnon, Erin, author
Publication:
[Harrisburg, Pa.] : Pennsylvania Patient Safety Authority, [2013]
Subject(s):
Electronic Data Processing
Electronic Health Records
Medical Errors -- prevention & control
Medical Errors -- statistics & numerical data
Medical Order Entry Systems
Medication Errors -- prevention & control
Medication Errors -- statistics & numerical data
Software
Equipment Design
Equipment Safety
Patient safety
Humans
Pennsylvania
United States

9. Medical devices: cancer risk led FDA to warn against certain uses of power morcellators and recommend new labeling : report to Congressional requesters

Publication:
Washington, D.C. : U.S. Government Accountability Office, February 2017
Subject(s):
Device Approval
Equipment Safety
Morcellation -- adverse effects
Morcellation -- instrumentation
Product Labeling
Leiomyoma -- surgery
Uterine Neoplasms -- surgery
Humans
United States
United States. Food and Drug Administration

10. Retained bioburden on surgical instruments after reprocessing: are we just scraping the surface?

Author(s):
Davis, James, author
Publication:
[Harrisburg, Pa.] : Pennsylvania Patient Safety Authority, June 2017
Subject(s):
Biofilms
Decontamination
Equipment Contamination -- prevention & control
Equipment Contamination -- statistics & numerical data
Equipment Reuse
Equipment Safety
Surgical Instruments -- microbiology
Cross Infection -- prevention & control
Patient safety
Sterilization
Humans
Pennsylvania
United States

11. Emergency use authorization of medical products and related authorities: guidance for industry and other stakeholders

Publication:
Silver Spring, MD : Food and Drug Administration, U.S. Department of Health and Human Services, January 2017
Subject(s):
Civil Defense -- legislation & jurisprudence
Device Approval
Drug Approval
Emergencies
Terrorism
Emergency Medical Services
Equipment Safety
Off-Label Use
Public Health
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Department of Homeland Security.
United States. Food and Drug Administration.

12. Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, August 31, 2017
Subject(s):
Equipment and Supplies
Equipment Safety
Evidence-Based Medicine
Product Surveillance, Postmarketing
Data Collection
Data Interpretation, Statistical
Decision Making
Device Approval
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

13. Establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of human papillomaviruses: guidance for Industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 15, 2017
Subject(s):
Device Approval
Papillomavirus Infections -- diagnosis
Reagent Kits, Diagnostic -- standards
Cervix Uteri -- cytology
Cervix Uteri -- virology
Equipment Failure
Equipment Safety
Genotyping Techniques -- standards
Mass Screening
Papillomaviridae -- classification
Papillomaviridae -- genetics
Quality Control
Reference Standards
Reproducibility of Results
Research Design
Specimen Handling
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

14. Data Snapshot: dislodged tubes and lines

Author(s):
Feil, Michelle, author
Publication:
[Harrisburg, Pa.] : Pennsylvania Patient Safety Authority, September 2017
Subject(s):
Catheterization -- adverse effects
Catheterization -- mortality
Catheters -- adverse effects
Equipment Failure
Equipment Safety
Intubation -- adverse effects
Intubation -- instrumentation
Intubation -- mortality
Catheterization, Peripheral -- adverse effects
Catheterization, Peripheral -- instrumentation
Catheterization, Peripheral -- mortality
Catheters, Indwelling -- adverse effects
Drainage -- adverse effects
Drainage -- instrumentation
Drainage -- mortality
Intubation, Gastrointestinal -- adverse effects
Intubation, Gastrointestinal -- instrumentation
Intubation, Gastrointestinal -- mortality
Patient safety
Humans
Pennsylvania
United States

18. CT contrast media power injectors can rupture conventional IV sets

Publication:
[Harrisburg, Pa.] : Pennsylvania Patient Safety Authority, c2008
Subject(s):
Contrast Media
Cross Infection -- prevention & control
Equipment Failure
Injections, Intravenous -- instrumentation
Tomography, X-Ray Computed -- instrumentation
Equipment Safety
Guidelines as Topic
Pressure
Humans
Pennsylvania
United States
United States. Food and Drug Administration.

20. Tubing misconnections: making the connection to patient safety

Publication:
[Harrisburg, Pa.] : Pennsylvania Patient Safety Authority, c2010
Subject(s):
Equipment Design -- adverse effects
Equipment Safety
Medical Errors -- prevention & control
Safety Management -- methods
Catheterization -- adverse effects
Catheterization -- instrumentation
Drug Delivery Systems -- instrumentation
Enteral Nutrition -- adverse effects
Enteral Nutrition -- instrumentation
Equipment and Supplies, Hospital
Infusions, Intravenous -- adverse effects
Infusions, Intravenous -- instrumentation
Intubation -- adverse effects
Intubation -- instrumentation
Materials Management, Hospital
Humans
United States

23. Tubular dressing retainer: retention without restriction

Publication:
[Harrisburg, Pa.] : Pennsylvania Patient Safety Authority, c2008
Subject(s):
Bandages -- adverse effects
Finger Injuries -- etiology
Finger Injuries -- prevention & control
Infarction -- etiology
Infarction -- prevention & control
Medical Errors -- prevention & control
Vascular System Injuries -- etiology
Vascular System Injuries -- prevention & control
Equipment Safety
Fingers -- blood supply
Inservice Training
Humans
Pennsylvania
United States

24. Surgical site markers: putting your mark on patient safety

Publication:
[Harrisburg, Pa.] : Pennsylvania Patient Safety Authority, c2008
Subject(s):
Cross Infection -- prevention & control
Equipment Contamination -- prevention & control
Equipment Reuse
Ink
Medical Errors -- prevention & control
Preoperative Care
Surgical Procedures, Operative
Anti-Infective Agents, Local
Chlorhexidine
Equipment Safety
Gentian Violet
Iodine
Methicillin-Resistant Staphylococcus aureus
2-Propanol
Skin
Writing
Humans
Pennsylvania
United States

36. FDA medical device reviews: evaluation is needed to assure requests for additional information follow a least burdensome approach : report to Congressional requestors

Publication:
Washington, DC : United States Government Accountability Office, December 2017
Subject(s):
Device Approval -- standards
Equipment Safety
Federal Government
Forecasting
Government Regulation
Inservice Training
Humans
United States
United States. Food and Drug Administration.

37. Implantable devices: regulatory framework and reform options

Author(s):
Lind, Keith D., author
Publication:
Washington, DC : AARP Public Policy Institute, August 2017
Subject(s):
Government Regulation
Prostheses and Implants -- adverse effects
Prostheses and Implants -- standards
Clinical Trials as Topic
Device Approval
Equipment Failure
Equipment Safety
Product Surveillance, Postmarketing
Registries
Humans
United States
United States. Food and Drug Administration.

38. Making patient-controlled analgesia safer for patients

Publication:
[Harrisburg, Pa.] : Pennsylvania Patient Safety Authority, c2011
Subject(s):
Analgesia, Patient-Controlled -- instrumentation
Analgesics, Opioid -- administration & dosage
Medication Errors -- prevention & control
Analgesia, Patient-Controlled -- adverse effects
Analgesics, Opioid -- adverse effects
Equipment Safety
Infusion Pumps
Respiratory Insufficiency -- chemically induced
Humans
Pennsylvania
United States

40. Class III obese patients: is your hospital equipped to address their needs?

Publication:
[Harrisburg, Pa.] : Pennsylvania Patient Safety Authority, c2013
Subject(s):
Bariatrics -- instrumentation
Equipment and Supplies, Hospital
Equipment Safety
Facility Design and Construction
Health Services Needs and Demand
Obesity, Morbid -- classification
Body Mass Index
Health Care Surveys
Health Facilities
Inservice Training
Ownership
Humans
Pennsylvania
United States

42. Identify sufficient supplemental oxygen for patient intrahospital transport

Author(s):
Gardner, Lea Anne, author
Publication:
[Harrisburg, Pa.] : Pennsylvania Patient Safety Authority, September 2015
Subject(s):
Hypoxia -- prevention & control
Medical Errors -- prevention & control
Oxygen Inhalation Therapy -- instrumentation
Transportation of Patients
Equipment Safety
Hospitals
Oxygen -- administration & dosage
Patient safety
Humans
Pennsylvania
United States

44. Conventional Foley catheters--performance criteria for safety and performance based pathway: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, August 14, 2020
Subject(s):
Equipment Design
Equipment Safety
Urinary Catheterization
Urinary Catheters -- standards
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

45. Cutaneous electrodes for recording purposes--performance criteria for safety and performance based pathway: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, August 14, 2020
Subject(s):
Electrodes
Equipment Design
Equipment Safety
Electrocardiography
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

46. Postmarketing adverse event reporting for medical products and dietary supplements during a pandemic

Publication:
Silver Spring, MD : Office of Counterterrorism and Emerging Threats, May 2020
Subject(s):
Dietary Supplements -- adverse effects
Drug-Related Side Effects and Adverse Reactions
Equipment Design -- adverse effects
Equipment Safety
Product Surveillance, Postmarketing
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

47. Technical considerations for non-clinical assessment of medical devices containing nitinol: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, July 9, 2021
Subject(s):
Alloys
Equipment Design
Equipment Safety
Nickel
Titanium
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

48. Basic safety and essential performance of medical electrical equipment, medical electrical systems, and laboratory medical equipment: standards specific information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program : guidance for industry, accreditation bodies, testing laboratories, and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 25, 2020
Subject(s):
Accreditation
Electricity
Equipment Safety
Equipment and Supplies
Mechanical Tests
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

50. Breast implants: certain labeling recommendations to improve patient communication : guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, September 29, 2020
Subject(s):
Breast Implants
Equipment Safety
Product Labeling
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

51. Self-monitoring blood glucose test systems for over-the-counter use: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, September 29, 2020
Subject(s):
Blood Glucose Self-Monitoring
Device Approval
Equipment Safety
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

52. Use of International Standard ISO 10993-1: "Biological evaluation of medical devices - part 1 : evaluation and testing within a risk management process" : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 4, 2020
Subject(s):
Device Approval
Equipment Failure
Equipment Safety
Equipment and Supplies -- standards
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

53. Spinal plating systems: performance criteria for safety and performance based pathway : guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, December 11, 2020
Subject(s):
Bone Plates
Equipment Design
Equipment Safety
Spinal Cord
Spinal Fusion
Materials Testing
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

54. Orthopedic non-spinal metallic bone screws and washers: performance criteria for safety and performance based pathway : guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, December 11, 2020
Subject(s):
Bone Screws
Equipment Safety
Orthopedic Equipment
Orthopedic Fixation Devices
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

55. Magnetic resonance (MR) receive-only coil: performance criteria for safety and performance based pathway : guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, December 11, 2020
Subject(s):
Equipment Safety
Magnetic Resonance Imaging
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

57. Testing and labeling medical devices for safety in the magnetic resonance (MR) environment: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, May 20, 2021
Subject(s):
Device Approval
Equipment Safety
Magnetic Resonance Imaging -- instrumentation
Product Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

58. Peripheral vascular atherectomy devices: premarket notification [510(k)] submissions : guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, May 20, 2021
Subject(s):
Atherectomy -- instrumentation
Device Approval
Equipment Safety
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

59. Implanted brain-computer interface (BCI) devices for patients with paralysis or amputation: non-clinical testing and clinical considerations : guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, May 20, 2021
Subject(s):
Amputation
Brain-Computer Interfaces
Equipment Design
Equipment Safety
Paralysis
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

60. Facet screw systems: performance criteria for safety and performance based pathway : guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, April 13, 2022
Subject(s):
Bone Screws -- standards
Device Approval
Equipment Safety
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

61. Denture base resins: performance criteria for safety and performance based pathway : guidance for industry and Food and Drug Administration Staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, April 13, 2022
Subject(s):
Denture Bases -- standards
Equipment Safety
Resins, Synthetic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

62. Orthopedic fracture fixation plates: performance criteria for safety and performance based pathway : guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, April 11, 2022
Subject(s):
Device Approval
Equipment Safety
Fracture Fixation
Orthopedic Fixation Devices -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

63. Quality of healthcare

Author(s):
Brude, Sydney, author
White, Robert S., author
Publication:
[Toronto, Ontario] : Thomson Reuters, 23-December-2019
Subject(s):
Legislation, Medical
Patient Safety -- legislation & jurisprudence
Quality of Health Care -- legislation & jurisprudence
Ambulatory Care Facilities -- legislation & jurisprudence
Drug Costs
Elder Abuse
Equipment Failure
Equipment Safety
Health Facilities -- legislation & jurisprudence
Legislation, Hospital
Medicare
Nursing Homes -- legislation & jurisprudence
Quality Indicators, Health Care -- legislation & jurisprudence
State Government
Surgicenters
Veterans Health
Humans
United States
Centers for Medicare & Medicaid Services (U.S.)

64. Medical devices

Author(s):
White, Robert S., author
Publication:
[Toronto, Ontario] : Thomson Reuters, 23-December-2019
Subject(s):
Device Approval -- legislation & jurisprudence
Equipment and Supplies
Medical Device Legislation
Computer Security
Equipment and Supplies -- supply & distribution
Equipment Failure
Equipment Reuse
Equipment Safety
Liability, Legal
Medical Device Recalls
Humans
United States
United States. Department of Health and Human Services.

65. Business practices

Author(s):
Steiner, David J., author
Publication:
Toronto, Ontario : Thomson Reuters, 23-December-2019
Subject(s):
Commerce
Drug Industry -- legislation & jurisprudence
Equipment and Supplies
Legislation, Drug
Analgesics, Opioid
Crime
Equipment Failure
Equipment Safety
Federal Government
Fraud
Medical Device Recalls
Opioid-Related Disorders -- epidemiology
Patents as Topic
Prescription Drug Diversion
Humans
United States

67. Class II special controls guideline: in vitro diagnostic devices for Bacillus spp. detection : guideline for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, April 1, 2019
Subject(s):
Bacillus
Equipment Safety
Reagent Kits, Diagnostic -- classification
Reagent Kits, Diagnostic -- standards
Bacteriophage Typing -- classification
Enzyme-Linked Immunosorbent Assay -- classification
Fluorescent Antibody Technique -- classification
Nucleic Acid Amplification Techniques -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

68. Medical x-ray imaging devices conformance: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, May 8, 2019
Subject(s):
Device Approval -- standards
Electrical Equipment and Supplies -- classification
Electrical Equipment and Supplies -- standards
Radiography -- classification
Radiography -- instrumentation
Equipment Safety
Guideline Adherence
Tomography Scanners, X-Ray Computed -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

69. Policy clarification for certain fluoroscopic equipment requirements: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, May 8, 2019
Subject(s):
Fluoroscopy -- standards
Radiation Exposure -- standards
Equipment Safety
Fluoroscopy -- instrumentation
Radiation Exposure -- prevention & control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

70. Laser products: conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 : (Laser Notice No. 56) : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, May 8, 2019
Subject(s):
Equipment Safety
Lasers -- classification
Lasers -- standards
Certification
Device Approval -- standards
Guideline Adherence
Product Labeling
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

71. Classification and requirements for laser illuminated projectors (LIPs): (Laser Notice No. 57) : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, May 8, 2019
Subject(s):
Equipment Safety
Lasers -- classification
Lasers -- standards
Device Approval
Lasers -- adverse effects
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

72. Marketing clearance of diagnostic ultrasound systems and transducers: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, June 27, 2019
Subject(s):
Device Approval
Transducers
Ultrasonography -- instrumentation
Equipment Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

73. Process to request a review of FDA's decision not to issue certain export certificates for devices: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, November 14, 2019
Subject(s):
Commerce -- legislation & jurisprudence
Equipment and Supplies -- standards
Device Approval -- legislation & jurisprudence
Equipment Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

75. VA health care: improvements in oversight needed for reusable medical equipment : testimony before the Subcommittee on Oversight and Investigations, Committee on Veterans’ Affairs, House of Representatives

Publication:
Washington, DC : United States Government Accountability Office, September 5, 2018
Subject(s):
Equipment Reuse
Equipment Safety
Veterans Health
Sterilization
United States
United States. Department of Veterans Affairs.

77. Cybersecurity in medical devices: refuse to accept policy for cyber devices and related systems under section 524B of the FD&C Act : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, March 30, 2023
Subject(s):
Computer Security -- legislation & jurisprudence
Device Approval
Equipment Safety
Government Regulation
United States
United States.