International Standards for Bulb Syringes used to Suction Noses of Newborns?

A

asha1

#1
Can anyone point me toward any standards/specifications/guidelines for manual bulb suction devices used to suction the nose and mouth of newborn babies? I'm talking about the basic bulb syringes you see in hospitals...
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Can anyone point me toward any standards/specifications/guidelines for manual bulb suction devices used to suction the nose and mouth of newborn babies? I'm talking about the basic bulb syringes you see in hospitals...
Any medical device experts who can help?

Thank you!

Stijloor.
 
S

SteveK

#3
The closest Standard I know is "Medical suction equipment - Manually powered suction equipment" EN ISO 10079-2:2009.

Steve
 

bio_subbu

Super Moderator
#4
Can anyone point me toward any standards/specifications/guidelines for manual bulb suction devices used to suction the nose and mouth of newborn babies? I'm talking about the basic bulb syringes you see in hospitals...
Can you please explain little more about your product intended use?. Are you trying to inquire about Infant Mucus Extractor?. Is so, Mucus Extractor is classified in FDA 21 CFR 880.6740 “Vacuum-powered body fluid suction apparatus”

Normally, bulb is not recommended for suctioning the mouth and nose unless special cleaning facilities are available because it is difficult to clean. A dirty bulb can become a source of cross-contamination.
 
A

asha1

#5
Thanks so much for the responses. I did purchase the ISO 10079-2:1999 (I don't know if there are significant changes in the 10079-2:2009).

Basically we are looking at available manual suction devices (i.e., bulb syringes, bulb suction, etc) for use in low-resource settings --- meaning a midwife or traditional birth attendant delivering a baby in a home (far from clinics) needs low-cost, reusable tools to prevent birth asphyxia. So, no electricity available and the device needs to be cleanable (realistically, probably people are going to clean as best they can and reuse). What if there were a bulb that opened widely for better cleaning?

There are many considerations and specifications to take into account - we want to make sure we have all the info possible, such as any international recommendations/standards/etc.

Any additional guidance would be appreciated. I am a not a technical person but am trying to find out what I can!
 
S

SteveK

#6
ISO 10079-2:1999 is the same text as ISO 10079-2:2009, it is just when adopted in Europe as an EN ISO it had an annex added to link to MDD 93/42/EEC.

My understanding is that bulbs for aspirating neonates are single use sterile items. Alternatives are hand operated manual units with disposable containers e.g. the Laerdal V-Vac (http://www.laerdal.co.uk/doc/10926678/V-VAC-Manual-Suction.html). Just do a search, there are plenty of alternatives out there.

FYI ambulance/paramedic crews will typically carry a portable electrical suction unit together with a manual unit for back-up.

Steve
 
A

asha1

#7
Thanks Steve K for your post. Yes, suction bulbs should be single use, but in practice this is not always the case - I am talking about very poor remote settings (village level of health care=midwives, traditional birth attendants, and/or family members) in places like Bangladesh, India, Uganda, Vietnam, etc. At the district level they may have hand-operated manual suction units like the Laerdal V-Vac, but not at the level I am referrring to - nor would there be any emergency services to assist. Thanks so much for confirming the contents of ISO 10079-2:1999! It's good to know that this is indeed the only applicable (somewhat) standard.
 
Thread starter Similar threads Forum Replies Date
Sidney Vianna Optimizing Standards for Regulatory Use - International Medical Dev. Regulators Forum Other Medical Device Regulations World-Wide 0
S Referencing International Standards as Design Input Design and Development of Products and Processes 5
N International / Traceable Standards - Procedures for Calipers, Micrometers, Etc. ISO 17025 related Discussions 2
J International Standards governing Test Method Validations ISO 13485:2016 - Medical Device Quality Management Systems 1
M Calibration Procedure Traceable to National/International Standards (API Q1 9th Ed) Oil and Gas Industry Standards and Regulations 3
M Basic International Standards required for a Manufacturing Industry (Optical Media) Other ISO and International Standards and European Regulations 4
M Differences between international and regional standards (EN, AAMI, CSA...) Other Medical Device Related Standards 6
D International Standards (ISO or MIL) for MTBV Reliability Analysis - Predictions, Testing and Standards 4
S The days before International Standards - Has ISO done what it was supposed to? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Measurement Standards Traceable to International or National Measurement Standards AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
T Are there any International Conferences related to ISO/IEC 27000 series standards IEC 27001 - Information Security Management Systems (ISMS) 1
A Plaster of Paris Medical Immobilization Cast - International Standards? ISO 13485:2016 - Medical Device Quality Management Systems 6
Sidney Vianna ISO/IEC Guide 63:2012 - Safety Aspects in International Standards for Medical Devices Other Medical Device Related Standards 1
Sidney Vianna New Collection of International Case Studies proves Economic Benefits of Standards Other ISO and International Standards and European Regulations 1
M Clarifying the many different Medical Device national and international standards Other Medical Device Related Standards 4
J International standards or guideline for the use of CMM (Cordinate measuring machine) Various Other Specifications, Standards, and related Requirements 5
Sidney Vianna ISO brochure clarifies distinctions between International Standards and private ones Other ISO and International Standards and European Regulations 2
T ISO 9001:2008 7.6 (traceable to international or national measurement standards)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
E RDC 59 - GMP for medical products Brazil versus compatible international standards Other ISO and International Standards and European Regulations 4
A Tracking Revision Status of External Documents - International and American Standards Other ISO and International Standards and European Regulations 1
gard2372 International Standards BS/EN/DIN/ISO U.S. Equivalents Matrix Other ISO and International Standards and European Regulations 2
A Where can I buy VDA 4, VDA 6 and other national or international standards? VDA Standards - Germany's Automotive Standards 3
M International Standards QS-9000 - American Automotive Manufacturers Standard 2
S What are the International Forging Requirements for Nitrogen Strengthened Stainless Steel? EU Medical Device Regulations 3
D ISO 9001 certificate issued by QMS International for 10 years - legit? Registrars and Notified Bodies 17
J Leveraging FDA 510k Clearance for International Registrations Other Medical Device Regulations World-Wide 2
Sidney Vianna Informational IAF and ILAC Seek Contractor for Establishment of a Single International Organization for Accreditation ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 2
M Class I - International Registrations EU Medical Device Regulations 3
E Packaging Specifications Mercedes-Benz U.S. International IATF 16949 - Automotive Quality Systems Standard 4
F Mig Welded Components - IMDS International Material Data System RoHS, REACH, ELV, IMDS and Restricted Substances 1
M Informational Publication of Draft Health Canada Implementation Guidance for the International Medical Device Regulators Forum Table of Contents Format Medical Device and FDA Regulations and Standards News 0
M Informational RIVM – Summary International Expert Meeting on breast implant-associated lymphoma Medical Device and FDA Regulations and Standards News 0
Sidney Vianna Medical Device News International exposé of the harm caused by poorly tested medical devices. Other Medical Device Regulations World-Wide 12
Wes Bucey International Manufacturing Technology Show - 10 September 2018 - Chicago (meet up?) Coffee Break and Water Cooler Discussions 6
qualprod Which standard to follow, local or international? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B ISO 17100 (Requirements for Translation Services) International Translations Other ISO and International Standards and European Regulations 4
S Where is a good place to get IMDS (International Material Data System) Training? IATF 16949 - Automotive Quality Systems Standard 3
Marc IAF (international accreditation forum) - Mandatory Documents (MD Series) ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 0
Marc "Elsmar 90" International Quality Standard anyone? Other ISO and International Standards and European Regulations 33
F Future Plan for IMDS (International Material Data System) RoHS, REACH, ELV, IMDS and Restricted Substances 5
R Determination of IP (International Protection Marking) Rating IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
U ISO 9001 Certification for Highly Distributed International Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
automoto International Problem Solving Guide Problem Solving, Root Cause Fault and Failure Analysis 2
AnaMariaVR2 The International Pharmacopoeia (Ph. Int.) WHO US Food and Drug Administration (FDA) 1
I International Sales Legal/Regulatory Gray Area? CE Marking (Conformité Européene) / CB Scheme 3
M FDA Acceptance of ISO 13485 Reports from a Recognized International Program Other US Medical Device Regulations 4
I International Accreditation Board of Bristol, UK ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 11
Jen Kirley This international consultant thing sure is a ride! Career and Occupation Discussions 13
S IATF (International Automotive Task Force) Rules 4th edition changes IATF 16949 - Automotive Quality Systems Standard 1
P IMDRF (International Medical Devices Regulators Forum)guidance on standalone software Medical Information Technology, Medical Software and Health Informatics 1

Similar threads

Top Bottom