Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello All

I would very much appreciate your thought processes and pearls of wisdom related to the relationship between delay in surgery and MDR reportability.  FDA's guidance is clear that an event should not be considered reportable solely on the basis of a delay in surgery, but if the delay is directly associated with the device then the decision-making process becomes muddy to me.

I am aware that some companies specify a delay of surgery that they consider to be significant when assessing for reportability (e.g., 15 minutes or 30 minutes).  But it's not clear to me whether device-related surgical delays of > a specific duration are being considered serious injuries in their own right, or whether the duration of the surgical delay is merely being used as a trigger to indicate that a more critical review for reportability should be conducted.

For example, an implant device breaks during implantation.  The broken implant is removed during the procedure without harm to the patient, and a new implant is successfully implanted.  Obviously the medical intervention to remove the broken implant will take a certain amount of time, but how should this amount of time be taken into the MDR reportability determination? 

All assuming that the patient was not overtly harmed: Does a device-related medical intervention exceeding a specific duration constitute a serious injury that would require reporting?  How does the determination whether the device malfunctioned (versus it breaking for another reason) come into the thought process? 

Thank you very much for your time!

This message was posted by a user wishing to remain anonymous

​Anon,

"Does a device-related medical intervention exceeding a specific duration constitute a serious injury that would require reporting?"

• See the definition of a serious injury:  A serious injury is an injury or illness that is life threatening; results in permanent impairment of a body function or permanent damage to a body structure; or necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

"How does the determination whether the device malfunctioned (versus it breaking for another reason) come into the thought process?"

• How can a device break without malfunctioning?

"How should this amount of time be taken into the MDR reportability determination?"

• Obviously it's unhealthy to spend extra time under anaesthesia and/or lying paralysed in a possibly awkward position, so there is a possibility of harm, and obviously the constant attendance of the surgical team helps to protect the patient. The key for determining reportability may be considering if this hazardous situation is "likely" to cause or contribute to a death or serious injury.

Rgds,
Original Message:
Sent: 25-Jun-2019 09:27
From: Anonymous Member
Subject: Delay of Surgery

This message was posted by a user wishing to remain anonymous

Hello All

I would very much appreciate your thought processes and pearls of wisdom related to the relationship between delay in surgery and MDR reportability.  FDA's guidance is clear that an event should not be considered reportable solely on the basis of a delay in surgery, but if the delay is directly associated with the device then the decision-making process becomes muddy to me.

I am aware that some companies specify a delay of surgery that they consider to be significant when assessing for reportability (e.g., 15 minutes or 30 minutes).  But it's not clear to me whether device-related surgical delays of > a specific duration are being considered serious injuries in their own right, or whether the duration of the surgical delay is merely being used as a trigger to indicate that a more critical review for reportability should be conducted.

For example, an implant device breaks during implantation.  The broken implant is removed during the procedure without harm to the patient, and a new implant is successfully implanted.  Obviously the medical intervention to remove the broken implant will take a certain amount of time, but how should this amount of time be taken into the MDR reportability determination?

All assuming that the patient was not overtly harmed: Does a device-related medical intervention exceeding a specific duration constitute a serious injury that would require reporting?  How does the determination whether the device malfunctioned (versus it breaking for another reason) come into the thought process?

Thank you very much for your time!

This message was posted by a user wishing to remain anonymous

​Given the statement made below:

• See the definition of a serious injury:  A serious injury is an injury or illness that is life threatening; results in permanent impairment of a body function or permanent damage to a body structure; or necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

and supposing this is an implantable device subject to having to be replaced due to breakage, if the device breaks and the surgical team sutures up the patient and goes home -- does the patient suffer permanent impairment of a body function or permanent damage to a body structure?

If the answer the either is yes, and medical intervention (i.e. replacing the broken implant with another viable implant) is required to prevent such impairment or damage, this is not a question of delay of surgery -- the fact that the implant "broke" necessitated a replacement surgery and this is a serious injury that requires reporting in the US.  Further investigation may result in a final report that the device "broke" because it was improperly used, overstressed beyond limits, or it malfunctioned and the final report should state whether the device was at fault or not.
Original Message:
Sent: 04-Jul-2019 14:26
From: Anonymous Member
Subject: Delay of Surgery

This message was posted by a user wishing to remain anonymous

​Anon,

"Does a device-related medical intervention exceeding a specific duration constitute a serious injury that would require reporting?"

• See the definition of a serious injury:  A serious injury is an injury or illness that is life threatening; results in permanent impairment of a body function or permanent damage to a body structure; or necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

"How does the determination whether the device malfunctioned (versus it breaking for another reason) come into the thought process?"

• How can a device break without malfunctioning?

"How should this amount of time be taken into the MDR reportability determination?"

• Obviously it's unhealthy to spend extra time under anaesthesia and/or lying paralysed in a possibly awkward position, so there is a possibility of harm, and obviously the constant attendance of the surgical team helps to protect the patient. The key for determining reportability may be considering if this hazardous situation is "likely" to cause or contribute to a death or serious injury.

Rgds,
Original Message:
Sent: 25-Jun-2019 09:27
From: Anonymous Member
Subject: Delay of Surgery

This message was posted by a user wishing to remain anonymous

Hello All

I would very much appreciate your thought processes and pearls of wisdom related to the relationship between delay in surgery and MDR reportability.  FDA's guidance is clear that an event should not be considered reportable solely on the basis of a delay in surgery, but if the delay is directly associated with the device then the decision-making process becomes muddy to me.

I am aware that some companies specify a delay of surgery that they consider to be significant when assessing for reportability (e.g., 15 minutes or 30 minutes).  But it's not clear to me whether device-related surgical delays of > a specific duration are being considered serious injuries in their own right, or whether the duration of the surgical delay is merely being used as a trigger to indicate that a more critical review for reportability should be conducted.

For example, an implant device breaks during implantation.  The broken implant is removed during the procedure without harm to the patient, and a new implant is successfully implanted.  Obviously the medical intervention to remove the broken implant will take a certain amount of time, but how should this amount of time be taken into the MDR reportability determination?

All assuming that the patient was not overtly harmed: Does a device-related medical intervention exceeding a specific duration constitute a serious injury that would require reporting?  How does the determination whether the device malfunctioned (versus it breaking for another reason) come into the thought process?

Thank you very much for your time!

Fellow RAPS members:

The follow-up comments regarding the need to report as an SI  MDR are valid.   The patient is exposed to risk because of the extended surgical time and surgical intervention is necessary to remove the broken device and replace with a functional device.

I would not, however, make the assumption that the device  breakage is the result of a  device malfunction.  Depending upon the MDR investigation, the manufacturer may find that user error caused the device to break.  Thus the device, which met specification upon delivery, did not malfunction. 

In that case, the manufacturer would want to consider if changes to the device, packaging, instrumentation, or labeling, would prevent future occurrences of breakage during implantation.

------------------------------
Michael Morton RAC, FRAPS
Consultant
Durango CO
United States
------------------------------

Original Message:
Sent: 25-Jun-2019 09:27
From: Anonymous Member
Subject: Delay of Surgery

This message was posted by a user wishing to remain anonymous

Hello All

I would very much appreciate your thought processes and pearls of wisdom related to the relationship between delay in surgery and MDR reportability.  FDA's guidance is clear that an event should not be considered reportable solely on the basis of a delay in surgery, but if the delay is directly associated with the device then the decision-making process becomes muddy to me.

I am aware that some companies specify a delay of surgery that they consider to be significant when assessing for reportability (e.g., 15 minutes or 30 minutes).  But it's not clear to me whether device-related surgical delays of > a specific duration are being considered serious injuries in their own right, or whether the duration of the surgical delay is merely being used as a trigger to indicate that a more critical review for reportability should be conducted.

For example, an implant device breaks during implantation.  The broken implant is removed during the procedure without harm to the patient, and a new implant is successfully implanted.  Obviously the medical intervention to remove the broken implant will take a certain amount of time, but how should this amount of time be taken into the MDR reportability determination?

All assuming that the patient was not overtly harmed: Does a device-related medical intervention exceeding a specific duration constitute a serious injury that would require reporting?  How does the determination whether the device malfunctioned (versus it breaking for another reason) come into the thought process?

Thank you very much for your time!

This message was posted by a user wishing to remain anonymous

Hi Michael

Thank you so much for your input.  We certainly do have issues where we have determined that breakage is the result of user error versus a true malfunction of the device itself, and this distinction certainly enters into the thought process for reportability and any corrective actions.

The crux of my confusion is how the length of the delay in surgery should enter into the decision process.  In either case described above (breakage due to user error, or breakage due to malfunction), if the broken device was removed and replaced successfully without serious injury to the patient, how would you take the duration of the surgical delay into consideration for determining MDR reportability?

Thank you again for any additional insights you may have!
Original Message:
Sent: 09-Jul-2019 13:37
From: Michael Morton
Subject: Delay of Surgery

Fellow RAPS members:

The follow-up comments regarding the need to report as an SI  MDR are valid.   The patient is exposed to risk because of the extended surgical time and surgical intervention is necessary to remove the broken device and replace with a functional device.

I would not, however, make the assumption that the device  breakage is the result of a  device malfunction.  Depending upon the MDR investigation, the manufacturer may find that user error caused the device to break.  Thus the device, which met specification upon delivery, did not malfunction.

In that case, the manufacturer would want to consider if changes to the device, packaging, instrumentation, or labeling, would prevent future occurrences of breakage during implantation.

------------------------------
Michael Morton RAC, FRAPS
Consultant
Durango CO
United States

Original Message:
Sent: 25-Jun-2019 09:27
From: Anonymous Member
Subject: Delay of Surgery

This message was posted by a user wishing to remain anonymous

Hello All

I would very much appreciate your thought processes and pearls of wisdom related to the relationship between delay in surgery and MDR reportability.  FDA's guidance is clear that an event should not be considered reportable solely on the basis of a delay in surgery, but if the delay is directly associated with the device then the decision-making process becomes muddy to me.

I am aware that some companies specify a delay of surgery that they consider to be significant when assessing for reportability (e.g., 15 minutes or 30 minutes).  But it's not clear to me whether device-related surgical delays of > a specific duration are being considered serious injuries in their own right, or whether the duration of the surgical delay is merely being used as a trigger to indicate that a more critical review for reportability should be conducted.

For example, an implant device breaks during implantation.  The broken implant is removed during the procedure without harm to the patient, and a new implant is successfully implanted.  Obviously the medical intervention to remove the broken implant will take a certain amount of time, but how should this amount of time be taken into the MDR reportability determination?

All assuming that the patient was not overtly harmed: Does a device-related medical intervention exceeding a specific duration constitute a serious injury that would require reporting?  How does the determination whether the device malfunctioned (versus it breaking for another reason) come into the thought process?

Thank you very much for your time!

Original Message------

This message was posted by a user wishing to remain anonymous

Hi Michael

Thank you so much for your input.  We certainly do have issues where we have determined that breakage is the result of user error versus a true malfunction of the device itself, and this distinction certainly enters into the thought process for reportability and any corrective actions.

The crux of my confusion is how the length of the delay in surgery should enter into the decision process.  In either case described above (breakage due to user error, or breakage due to malfunction), if the broken device was removed and replaced successfully without serious injury to the patient, how would you take the duration of the surgical delay into consideration for determining MDR reportability?

Thank you again for any additional insights you may have!

This message was posted by a user wishing to remain anonymous

Thank you so much for your response and insights!  Just as you suggested, we are currently establishing our thought process regarding delay of surgery with the assistance of surgeons who can help us assess how much of a delay should be considered significant.  Then we will be capturing this thought process in our adverse events reporting SOP.
Original Message:
Sent: 10-Jul-2019 16:58
From: Michael Morton
Subject: Delay of Surgery

Thank you for your good questions.  Let's look at your primary question of how the length of delay in surgery should enter into the decision.  Especially, if the broken device was removed and replaced successfully without serious injury to the patient.

The first part of the question depends largely upon the type of surgery.   If its simple outpatient surgery, perhaps under local anesthesia, a broken device doesn't seem to present much risk to the patient.  But as the risk of surgery increases, so does the risk to the patient.  Consider open heart surgery where the patient is on bypass.   Longer bypass time increases the risk for the patient.  Consider unanticipated factors, such as another appropriate sized device not being available.  So the wait time may become longer, or the surgical procedure itself may become more complicated.   Or, perhaps pieces of the broken device have to be retrieved.    Things can get complicated and risky for the patient.

Now, not all cases are like that.   And the FDA guidance does seem to allow a lot of decision-making on the part of the manufacturer.  (See 2.6)   https://www.fda.gov/media/86420/download  

I think that the best practice is for manufacturers to address the question of breakage, user error, and the potential for extended surgical time, in an internal SOP, part of the QSM.   If the manufacturer can set clear criteria, and clear rationale, about potential events, for their particular device(s), and whether those cases would be MDR reportable, then the company has a defense, should the question ever be asked by an internal auditor or by an external regulatory authority.  Such pre-established criteria also make decisions easier when MDR reporting is indicated.

Finally, although the quality system, including the MDR program, exists to protect patients,  adherence to a good system also protects the company.   For example, if the company were ever taken to court because of a broken device, one that caused an increase in surgical time, the company would want to be able to demonstrate that it had a robust procedure to address MDR reporting, and that the company had followed its own procedure.  Such documented behavior on the part of the company would be much more defensible that either a one-off decision, or a history of decisions that were not consistent.

Again, great questions.   I hope that this provides a perspective.

Regards,   MCM

--

https://www.mcmregulatory.com 

michael@mcmregulatory.com 

1-612-999-3247

Original Message------

This message was posted by a user wishing to remain anonymous

Hi Michael

Thank you so much for your input.  We certainly do have issues where we have determined that breakage is the result of user error versus a true malfunction of the device itself, and this distinction certainly enters into the thought process for reportability and any corrective actions.

The crux of my confusion is how the length of the delay in surgery should enter into the decision process.  In either case described above (breakage due to user error, or breakage due to malfunction), if the broken device was removed and replaced successfully without serious injury to the patient, how would you take the duration of the surgical delay into consideration for determining MDR reportability?

Thank you again for any additional insights you may have!

It isn't perfect, but we asked our CMO and several other surgeons how long of a delay would make them concerned about increased risks for the patients, as this likely varies by the type of surgery being conducted. Once they came up with a "maximum innocuous delay" we documented their thinking in our SOPs and use that as a guideline.

Not to say it couldn't be challenged, but I think it is at least defensible.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 10-Jul-2019 11:17
From: Anonymous Member
Subject: Delay of Surgery

This message was posted by a user wishing to remain anonymous

Hi Michael

Thank you so much for your input.  We certainly do have issues where we have determined that breakage is the result of user error versus a true malfunction of the device itself, and this distinction certainly enters into the thought process for reportability and any corrective actions.

The crux of my confusion is how the length of the delay in surgery should enter into the decision process.  In either case described above (breakage due to user error, or breakage due to malfunction), if the broken device was removed and replaced successfully without serious injury to the patient, how would you take the duration of the surgical delay into consideration for determining MDR reportability?

Thank you again for any additional insights you may have!
Original Message:
Sent: 09-Jul-2019 13:37
From: Michael Morton
Subject: Delay of Surgery

Fellow RAPS members:

The follow-up comments regarding the need to report as an SI  MDR are valid.   The patient is exposed to risk because of the extended surgical time and surgical intervention is necessary to remove the broken device and replace with a functional device.

I would not, however, make the assumption that the device  breakage is the result of a  device malfunction.  Depending upon the MDR investigation, the manufacturer may find that user error caused the device to break.  Thus the device, which met specification upon delivery, did not malfunction.

In that case, the manufacturer would want to consider if changes to the device, packaging, instrumentation, or labeling, would prevent future occurrences of breakage during implantation.

------------------------------
Michael Morton RAC, FRAPS
Consultant
Durango CO
United States

Original Message:
Sent: 25-Jun-2019 09:27
From: Anonymous Member
Subject: Delay of Surgery

This message was posted by a user wishing to remain anonymous

Hello All

I would very much appreciate your thought processes and pearls of wisdom related to the relationship between delay in surgery and MDR reportability.  FDA's guidance is clear that an event should not be considered reportable solely on the basis of a delay in surgery, but if the delay is directly associated with the device then the decision-making process becomes muddy to me.

I am aware that some companies specify a delay of surgery that they consider to be significant when assessing for reportability (e.g., 15 minutes or 30 minutes).  But it's not clear to me whether device-related surgical delays of > a specific duration are being considered serious injuries in their own right, or whether the duration of the surgical delay is merely being used as a trigger to indicate that a more critical review for reportability should be conducted.

For example, an implant device breaks during implantation.  The broken implant is removed during the procedure without harm to the patient, and a new implant is successfully implanted.  Obviously the medical intervention to remove the broken implant will take a certain amount of time, but how should this amount of time be taken into the MDR reportability determination?

All assuming that the patient was not overtly harmed: Does a device-related medical intervention exceeding a specific duration constitute a serious injury that would require reporting?  How does the determination whether the device malfunctioned (versus it breaking for another reason) come into the thought process?

Thank you very much for your time!

This message was posted by a user wishing to remain anonymous

Thank you Ginger!  I'm glad to hear that our strategy of working with our CMO and other surgeons seems like a sound way to proceed.
Original Message:
Sent: 11-Jul-2019 08:29
From: Ginger Glaser
Subject: Delay of Surgery

It isn't perfect, but we asked our CMO and several other surgeons how long of a delay would make them concerned about increased risks for the patients, as this likely varies by the type of surgery being conducted. Once they came up with a "maximum innocuous delay" we documented their thinking in our SOPs and use that as a guideline.

Not to say it couldn't be challenged, but I think it is at least defensible.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN

Original Message:
Sent: 10-Jul-2019 11:17
From: Anonymous Member
Subject: Delay of Surgery

This message was posted by a user wishing to remain anonymous

Hi Michael

Thank you so much for your input.  We certainly do have issues where we have determined that breakage is the result of user error versus a true malfunction of the device itself, and this distinction certainly enters into the thought process for reportability and any corrective actions.

The crux of my confusion is how the length of the delay in surgery should enter into the decision process.  In either case described above (breakage due to user error, or breakage due to malfunction), if the broken device was removed and replaced successfully without serious injury to the patient, how would you take the duration of the surgical delay into consideration for determining MDR reportability?

Thank you again for any additional insights you may have!
Original Message:
Sent: 09-Jul-2019 13:37
From: Michael Morton
Subject: Delay of Surgery

Fellow RAPS members:

The follow-up comments regarding the need to report as an SI  MDR are valid.   The patient is exposed to risk because of the extended surgical time and surgical intervention is necessary to remove the broken device and replace with a functional device.

I would not, however, make the assumption that the device  breakage is the result of a  device malfunction.  Depending upon the MDR investigation, the manufacturer may find that user error caused the device to break.  Thus the device, which met specification upon delivery, did not malfunction.

In that case, the manufacturer would want to consider if changes to the device, packaging, instrumentation, or labeling, would prevent future occurrences of breakage during implantation.

------------------------------
Michael Morton RAC, FRAPS
Consultant
Durango CO
United States

Original Message:
Sent: 25-Jun-2019 09:27
From: Anonymous Member
Subject: Delay of Surgery

This message was posted by a user wishing to remain anonymous

Hello All

I would very much appreciate your thought processes and pearls of wisdom related to the relationship between delay in surgery and MDR reportability.  FDA's guidance is clear that an event should not be considered reportable solely on the basis of a delay in surgery, but if the delay is directly associated with the device then the decision-making process becomes muddy to me.

I am aware that some companies specify a delay of surgery that they consider to be significant when assessing for reportability (e.g., 15 minutes or 30 minutes).  But it's not clear to me whether device-related surgical delays of > a specific duration are being considered serious injuries in their own right, or whether the duration of the surgical delay is merely being used as a trigger to indicate that a more critical review for reportability should be conducted.

For example, an implant device breaks during implantation.  The broken implant is removed during the procedure without harm to the patient, and a new implant is successfully implanted.  Obviously the medical intervention to remove the broken implant will take a certain amount of time, but how should this amount of time be taken into the MDR reportability determination?

All assuming that the patient was not overtly harmed: Does a device-related medical intervention exceeding a specific duration constitute a serious injury that would require reporting?  How does the determination whether the device malfunctioned (versus it breaking for another reason) come into the thought process?

Thank you very much for your time!