USFDA issues final guidance on "Reprocessing Medical Devices in Health Care Settings"

bio_subbu

Super Moderator
#1
Dear All

The US Food and Drug Administration (FDA) has published the final version of the guidance document titled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling”, The scope of this guidance is limited to devices that fall into any of the four reprocessing situations below.

1. Reusable medical devices initially supplied as sterile to the user and requiring the user to reprocess (i.e., clean and disinfect or sterilize) the device after initial use prior to the subsequent patient use.

2. Reusable medical devices initially supplied as non-sterile to the user and requiring the user to process (i.e., clean, clean and disinfect, or clean and sterilize) the device for initial use, as well as to reprocess the device after each use.

3. Reusable medical devices intended to be reused only by a single patient and intended to be reprocessed between each use.

4. Single-use medical devices initially supplied as non-sterile to the user, and requiring the user to process the device prior to its use.

For more details, please refer the attached guidance document and press announcement.
 

Attachments

Elsmar Forum Sponsor

Mark Meer

Trusted Information Resource
#2
Re: USFDA issues final guidance on "Reprocessing Medical Devices in Health Care Setti

Well, this seems to clarify the question of "does reprocessing include cleaning and low-level disinfection" raised in previous threads.

Cleaning and low-level disinfection are both considered reprocessing according to this guidance.

My concern: so according to this guidance, cleaning instructions must be validated? In the section on "non-critical devices" it states:
"Devices that will likely not become contaminated with pathogens during use (e.g.,room vital signs monitor) may not require disinfection, and therefore may be suitable for use after cleaning only. "

I'm presuming that such "cleaning" described here is not in the scope of this guidance. It would seem ridiculous to validate the cleaning process for e.g. "wipe with a damp cloth", that would accompany many non-critical devices.
 
Thread starter Similar threads Forum Replies Date
bio_subbu USFDA issues final guidance on Global Unique Device Identification Database (GUDID) Other US Medical Device Regulations 1
bio_subbu USFDA issues Final Guidance Document on InVitro Diagnostic Device (IVD) Studies 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
bio_subbu USFDA issues draft Guidance on the Acceptance of Medical Device Clinical Data Other US Medical Device Regulations 1
M Informational Several revised or updates USFDA guidance Medical Device and FDA Regulations and Standards News 0
M Informational USFDA final guidance – Safety and Performance Based Pathway Medical Device and FDA Regulations and Standards News 0
M Informational USFDA – Digital Health Update: The FDA Announces an Opportunity for Test Case Volunteers for the Test Plan for the Software Precertification Program Medical Device and FDA Regulations and Standards News 0
D USFDA vs NRTL/IEC 17025 Differences - Compliance testing lab ISO 17025 related Discussions 0
D USFDA vs NRTL/IEC 17025 Differences - Compliance testing lab US Food and Drug Administration (FDA) 6
M Informational USFDA final guidance – Unique Device Identification: Convenience Kits Medical Device and FDA Regulations and Standards News 0
M Informational USFDA final guidance – Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions Medical Device and FDA Regulations and Standards News 0
M Informational USFDA draft guidance – Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions Medical Device and FDA Regulations and Standards News 0
M Informational USFDA draft guidance – Technical Considerations for Non- Clinical Assessment of Medical Devices containing Nitinol Medical Device and FDA Regulations and Standards News 0
M Informational USFDA – Medical Devices; Anesthesiology Devices; Classification of the Ventilatory Electrical Impedance Tomograph Medical Device and FDA Regulations and Standards News 0
M Informational The USFDA Continues to Remind Facilities of the Importance of Following Duodenoscope Reprocessing Instructions: FDA Safety Communication Medical Device and FDA Regulations and Standards News 0
M Informational USFDA – Review framework for artificial intelligence-based medical devices Medical Device and FDA Regulations and Standards News 1
M Informational USFDA – Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Stand Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Draft Guidance – Review and Update of Device Establishment Inspection Processes and Standards Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Ethylene Oxide Sterilization for Medical Devices website Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Final Guidance – Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) Medical Device and FDA Regulations and Standards News 0
M Informational USFDA – Efforts to evaluate materials in medical devices to address potential safety questions Medical Device and FDA Regulations and Standards News 0
M Informational USFDA draft guidance – A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry Medical Device and FDA Regulations and Standards News 0
M Informational USFDA – FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 051 Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Draft Guidance – Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation – Non-clinical Testing and Clinical Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Final Rule – Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Guidance – Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) Medical Device and FDA Regulations and Standards News 0
M Informational USFDA – Refuse to Accept Policy for 510(k)s Medical Device and FDA Regulations and Standards News 1
M Informational USFDA draft guidance – Nonbinding Feedback After Certain FDA Inspections of Device Establishments Medical Device and FDA Regulations and Standards News 0
M Informational The USFDA Announces General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting on March 25-26, 2019 Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Final Guidance – Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA – Breast Implant Associated- Anaplastic Large Cell Lymphoma (BIA-ALCL) – Letter to Health Care Providers Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA draft guidance – Principles of Premarket Pathways for Combination Products; Draft Guidance for Industry; Availability Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Final Guidance – Safety and Performance Based Pathway Medical Device and FDA Regulations and Standards News 2
M Informational USFDA Final Guidance – Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Final Guidance – The Least Burdensome Provisions: Concept and Principles Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA – Safety and Performance Based Pathway Guidance Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Digital Health Update – New actions and documents Medical Device and FDA Regulations and Standards News 0
M FDA News Safety Alert – USFDA warns about safety risks of teething necklaces, bracelets to relieve teething pain or to provide sensory stimulation Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Final Report – MDUFA IV Independent Assessment of FDA’s Device Review Process Management Medical Device and FDA Regulations and Standards News 0
M FDA News Statement from USFDA on steps to strengthen the long-term safety oversight of the Essure device Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA – Reclassification of Electroconvulsive Therapy Devices Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Proposes to End Temporary Extension of GUDID’s Grace Period Medical Device and FDA Regulations and Standards News 3
M FDA News USFDA – Announcement of Safer Technologies Program (STeP) Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA – Breakthrough Devices Program final guidance Medical Device and FDA Regulations and Standards News 0
M FDA News Digital Health Update: USFDA Report on Non-Device Software Functions Now Available Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Final Guidance – Manufacturing Site Change Supplements: Content and Submission Medical Device and FDA Regulations and Standards News 1
M FDA News USFDA Final Rule – Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Draft Guidance – Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment Medical Device and FDA Regulations and Standards News 0
P DMF (Drug Master File) type V for Sterilization Processes for USFDA Submission Other US Medical Device Regulations 3
J Testing in China accepted by the USFDA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Listing Exempt Medical Devices with the USFDA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1

Similar threads

Top Bottom