Are mortuary/autopsy tables considered to be medical devices

#1
Hi everyone. I would be grateful for some advice regarding the following question:

Are mortuary/autopsy tables considered to be medical devices under the new regulations?

My initial reaction would be no. However, I can see there may be an argument that they could have a role in the "prognosis...of disease" (admittedly a bit late for the patient on the table), which is one of the definitions of medical purpose from the MDR. Also, they could provide "information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations".
 
Elsmar Forum Sponsor

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#2
I imagine a scenario where there is a potential new virus affecting and killing people and an autopsy is used to determine the mechanism of action and the table breaks. That seems far fetched tho.

However, if the body contains toxins and a table could fail in a way that spread those toxins in an uncontrolled state or infected the person performing the autopsy?
 

twanmul

Involved In Discussions
#3
This depends on the intended purpose which I guess is something along the lines of "for use in post mortem examinations as the "platform" for the cadaver." I don't think prognosis of disease is applicable (as you've alluded because that prognosis would be somewhat tardy) and the mortuary table isn't providing the in vitro information but post mortem itself if, so I don't think "...providing information by means of in vitro examination..." is applicable either.
I've highlighted the parts of the medical device definition which may be relevant (though again, the mortuary table is used as part of an investigation, rather than an investigatory tool):

"‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,

diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,

investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,

providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means."


I hope that this helps you to think about it in another way but it sounds to me like it may be an accessory at best if it is a device.
 
#4
This depends on the intended purpose which I guess is something along the lines of "for use in post mortem examinations as the "platform" for the cadaver." I don't think prognosis of disease is applicable (as you've alluded because that prognosis would be somewhat tardy) and the mortuary table isn't providing the in vitro information but post mortem itself if, so I don't think "...providing information by means of in vitro examination..." is applicable either.
I've highlighted the parts of the medical device definition which may be relevant (though again, the mortuary table is used as part of an investigation, rather than an investigatory tool):

"‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,

diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,

investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,

providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means."


I hope that this helps you to think about it in another way but it sounds to me like it may be an accessory at best if it is a device.
Thanks for the detailed response. From my understanding of the scope of the regulations, I think it is irrelevant that something is used as part of a medical procedure as opposed to being the primary tool in the medical procedure. For example, an operating table is not directly treating anyone, but since it is designed to be part of the treatment process, it is classified as a medical device. In contrast, an accessory would be something that played no part in the medical procedure (e.g. a battery charger for a medical device).

I think the answer as to whether a mortuary table is a medical device rests upon whether an autopsy is considered to be a medical procedure. This is something I am still unsure about.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#5
Depending on where the battery charger was used it could require testing for interference and compliance with 60601.
 

Pads38

Trusted Information Resource
#6
The EC publish a Classification Borderline guide.
One of the devices that had judgement passed upon it was a tool specifically for use in autopsy procedures. The judgement was that it should not be classified as a medical device. The same ruling would apply to the table.
 

dgrainger

Trusted Information Resource
#7
The Borderline manual is always useful as a reference document
It's hidden away on this page: Specific areas of development - Internal Market, Industry, Entrepreneurship and SMEs - European Commission
Direct link to current version: DocsRoom - European Commission

"1.22. Autopsy saw
- Background:​
The product under discussion is a saw with extractor unit intended for use only in the mortuary for autopsy. The question has arisen as to whether such a product can be considered to be a medical device, since it is claimed by the manufacturer that it is intended for diagnosis of disease, diagnosis of an injury or handicap or investigation of the anatomy or of a physiological process.​
- Outcome:​
This product should not be qualified as a medical device because it is not intended for use on living human beings."​
 
#8
The Borderline manual is always useful as a reference document
It's hidden away on this page: Specific areas of development - Internal Market, Industry, Entrepreneurship and SMEs - European Commission
Direct link to current version: DocsRoom - European Commission

"1.22. Autopsy saw
- Background:​
The product under discussion is a saw with extractor unit intended for use only in the mortuary for autopsy. The question has arisen as to whether such a product can be considered to be a medical device, since it is claimed by the manufacturer that it is intended for diagnosis of disease, diagnosis of an injury or handicap or investigation of the anatomy or of a physiological process.​
- Outcome:​
This product should not be qualified as a medical device because it is not intended for use on living human beings."​
That is exactly what I was after! Many thanks.

I did look at an older version of the borderline manual, however that version did not include autopsy saw. It must be a new addition.
 
Thread starter Similar threads Forum Replies Date
Proud Liberal Power Query to combine multiple tables of unequal number of columns Statistical Analysis Tools, Techniques and SPC 1
M IEC 60601-1-2 EMC Tables IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
V How to interpret AQL sampling tables AQL - Acceptable Quality Level 5
M How to Mathemetically Derive the AQL Tables given Lot Sizes AQL - Acceptable Quality Level 5
M Help interpreting MIL-STD-105E Single Sampling Plans Tables Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
pammesue Which Sampling Tables for AQL? Statistical Analysis Tools, Techniques and SPC 6
B AQL Sampling Tables Question Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
A Calibrated Surface Plates treated as General Use Tables General Measurement Device and Calibration Topics 9
A Where to obtain ANSI/ASQ Z1.9 C-1 and D-1 tables Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
A ANSI/ASQ Z1.4 tables for C=0 - Setting up a robust Sampling Inspection Scheme Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
A AQL Tables or Binomial/Poisson Method? Attribute Sampling Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
T Weight Load Testing Methods for Surgical Operating Tables ISO 13485:2016 - Medical Device Quality Management Systems 8
S Using Statistical Tables for Normal Distribution - Question and hopefully answers Statistical Analysis Tools, Techniques and SPC 5
S Student's T distribution/table & d2,d2* tables General Measurement Device and Calibration Topics 1
Jim Wynne Glass-top Patio Tables Shatter Without Warning Coffee Break and Water Cooler Discussions 14
S Who can provide me Dodge-Romig inspection tables? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
P ANSI/ASQ tables (Z1.4) / OC Curves - Percent accepted, how'd I do? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
Y Severity, Occurrence and Detection FMEA Ranking Tables - Guidelines? FMEA and Control Plans 8
S Can we modify tables mentioned in FMEA handbook according to our process? FMEA and Control Plans 2
H Tables to be taken to the Six Sigma Black Belt Exam Professional Certifications and Degrees 3
W Sampling - Murdoch and Barns book on Statistical Tables Pages 52 & 53 Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
G Do we need to take our own statistical tables for CQE Exam? Professional Certifications and Degrees 4
C BS6001 sampling tables - Seeking software with Alert for switching rules Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
M Dodge-Romig Sampling Inspection Tables - Seeking (possibly in Excel .xls?) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
D Need to purchase ANSI/ASQ Z1.4 & 1.9 - Sampling Procedures and Tables - Inspection Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
M MSA - d4 values above 3 trials - statistical constants tables Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
Tim Folkerts Antiquated Sampling Standards? Scrap paper tables like Z1.4 or MIL-STD-105E? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
WALLACE Six Sigma Formulas and Tables. Six Sigma 3
Atul Khandekar Where can I find Duncan's Tables (d2* and Degrees of Freedom) on the internet? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
Similar threads





























Top Bottom