Contaminated Sharp Medical Devices received by mail - Biohazard?

C

Calico

#1
Hi Everyone,

Along the medical device lines (couldn't find a good place to start this thread, sorry)..

I work for a call center that takes consumer adverse event calls for major pharmaceutical companies.

We have in the past received envelopes from a consumer with a "pill" in it that was meant to be sent to the product complaint department (at the pharmaceutical company).

Well today we received two regular envelopes via USPS that contained injectable devices (that had been used). One being a Genotropin Pen.

Not being a medical device manufacturer but having some common sense, wouldn't these be considered a biohazard since they contain a used needle? This has raised a red flag with me considering that our clerical person opened the envelopes to process the letters that were attached to these medical devices. The standard response when we receive a pill or pill bottle is to fed ex it to the product complaint group but I am not comfortable putting these devices into a fed Ex box.

Can anyone provide any guidance?

Thanks,
Callie
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Re: Can a shaving razor blade be classified as a medical device

(...) Well today we received two regular envelopes via USPS that contained injectable devices (that had been used). One being a Genotropin Pen. (...) wouldn't these be considered a biohazard since they contain a used needle?
Absolutely yes. Major safety hazard if uncapped.

I suggest that you set them aside in a safe place, and contact the relevant responsible company to provide you with packaging for safe and legal shipment to them, with provision for safety-aware opening of the package at the far end.

My understanding is that all of the major package services (i.e. UPS, FedEx, etc.) prohibit shipment of sharps--medical/contaminated or not--except USPS. USPS substantially limits such shipments--the original shipment to you probably was illegal. The regulations are at http://pe.usps.com/text/pub52/pub52apxc_022.htm. Your client company however may know of a carrier that will handle the shipment.
 
Thread starter Similar threads Forum Replies Date
A Handling of contaminated medical equipment Other Medical Device and Orthopedic Related Topics 0
A Transportation Requirements for Contaminated Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 5
R How do you handle 'Contaminated Wood Pallets'? US Food and Drug Administration (FDA) 16
T Documentation for Returned Contaminated Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 8
J Standard / Brown & Sharp Gage Tower model E8-5000 Manual General Measurement Device and Calibration Topics 1
S Sharp Edge testing method for Plastic or Sheet Metal Enclosure Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
J Checking the Theoretical Sharp of a Flush Head Bolt on an Optical Comparator Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
W Powder Coating Adherence to sharp edge of Steel Manufacturing and Related Processes 6
B Sharp Edge Measurement - Method of measuring how sharp the edge of a machined part is Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
M FDA Medical device reporting (Manufacturer in US; contract manufacturer OuS) US Food and Drug Administration (FDA) 0
JoCam Accessories for medical devices EU Medical Device Regulations 4
G Medical Device Auditor (CMDA) certification exam by ASQ - looking for input Career and Occupation Discussions 1
M Prescription Form - Medical Devices US Food and Drug Administration (FDA) 0
XRAY_3121 Drop Shipping Legend Medical Devices Other Medical Device Related Standards 0
B Documenting Medical Device Complaints after End of Life? Medical Device and FDA Regulations and Standards News 0
M Medical Device License as Distributor Canada Medical Device Regulations 8
M Preparing a document for Raw Material of Medical Device EU Medical Device Regulations 1
R Medical device regulations in African countries Other Medical Device Regulations World-Wide 0
Jessesun The application of ozone sterilization in medical treatment US Food and Drug Administration (FDA) 0
A Production line for medical devices Other Medical Device Related Standards 1
S Design & Development records for Medical Devices Packaging and Labelling ISO 13485:2016 - Medical Device Quality Management Systems 8
K MHLW MO169 2021 Japan Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostics Japan Medical Device Regulations 2
U Medical Devices Labeling Medical Device and FDA Regulations and Standards News 0
K Guidance on X-Ray Medical Devices for Animal Use - FDA US Food and Drug Administration (FDA) 0
Z Swiss Authorized representative & non-medical device regulations Other Medical Device Regulations World-Wide 0
T FDA UDI Question - Class II Medical Device Other US Medical Device Regulations 1
blackholequasar ISO 13485 certification prior to Medical Device Manufacturing... worth it? ISO 13485:2016 - Medical Device Quality Management Systems 4
dgrainger Informational Good news: Commission proposes a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation EU Medical Device Regulations 3
P Brexit Germany - Import Medical Device For Clinical Study EU Medical Device Regulations 0
M Medical Device Marketing Material - Control of Social Media 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Ed Panek Make sure you hire competent QA RA Folks before making a "Medical Device." Coffee Break and Water Cooler Discussions 1
dgrainger Informational MDCG 2021-24 - Guidance on classification of medical devices EU Medical Device Regulations 0
B Acquired Medical Device Product Line - Documentation Requirements for Device Master Record ISO 13485:2016 - Medical Device Quality Management Systems 7
S State Licensing requirements for Medical Devices sold in the US directly to hospitals and tissue banks 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
MedicalDevicesCanada How to find a medical device contract manufacturer, MDSAP certified? Canada Medical Device Regulations 4
B ISO 11197, Venting of Medical Supply Units - cl. 201.11.2.2.101 Other Medical Device Related Standards 2
Q Best country to import medical devices into Europe Other Medical Device and Orthopedic Related Topics 0
dgrainger Informational MHRA's Software and AI as a Medical Device Change Programme UK Medical Device Regulations 0
dgrainger Informational Consultation on the future regulation of medical devices in the United Kingdom UK Medical Device Regulations 1
S Medical Device - Technical Documentation structure EU Medical Device Regulations 1
JoCam On-product labels for Medical Devices EU Medical Device Regulations 3
LostLouie Archived Specifications and Drawings for Medical Device Technical Files EU Medical Device Regulations 4
B Reprocessing of an accessory for a medical device EU Medical Device Regulations 4
V Taiwan - Veterinary medical devices Other Medical Device Regulations World-Wide 1
K System of medical devices EU Medical Device Regulations 0
A Class 1 medical device - Thailand Other Medical Device Regulations World-Wide 0
D Dental application - medical product or not? Other US Medical Device Regulations 8
P Interchangeable/alternative parts in BOM (medical device) Manufacturing and Related Processes 4
U Is Initial Importer Status Required if a Medical Device is Manufactured and Sterilized by an OEM in the US Other US Medical Device Regulations 1
B Research Use Only (RUO) IVD Medical Devices in China China Medical Device Regulations 2

Similar threads

Top Bottom