Project Scope-DAM and DCM for Medical Devices
Please vote on the project scope for the DAM & DCM for Medical Devices project from Patient Care. Enter your name and Work Group along with your vote. Only one vote per Work Group please. Any comments added through the poll should also be distributed to the DESD list server.
Link to document: DAM & DCM for Medical Devices
- The electronic vote is closed but changes to the project scope identified during balloting need to be approved by Patient Care
- Summary - Passed (5/0/3/1)
- Number of participants: 8
- Most popular option: Affirmative
- Votes in favor: 5
- Comments: 1
- History: DESD Project Scope: DAM and DCM for Medical Devices
- 4/5/10 6:12:02 PM CEST · Austin Kreisler · Poll added by "Austin Kreisler" Options:
- 4/6/10 4:06:23 PM CEST · Alan Nicol (GAS) · Participant "Alan Nicol (GAS)" added OK: Abstain
- 4/13/10 3:42:49 PM CEST · Mead Walker (Patient Safety · Participant "Mead Walker (Patient Safety" added OK: Affirmative
- 4/13/10 3:58:51 PM CEST · Melvin Reynolds · Participant "Melvin Reynolds" added OK: Affirmative
- 4/13/10 5:25:07 PM CEST · Ed Tripp (RCRIM) · Participant "Ed Tripp (RCRIM)" added OK: Affirmative
- 4/16/10 5:56:31 PM CEST · Suzanne Gonzales-Webb (CBCC) · Participant "Suzanne Gonzales-Webb (CBCC)" added OK: Affirmative
- 4/16/10 10:15:00 PM CEST · Rita Altamore (PHER) · Participant "Rita Altamore (PHER)" added OK: Affirmative
- 4/16/10 10:18:22 PM CEST · Rita Altamore (PHER) · Comment by "Rita Altamore (PHER)" added
- 4/20/10 5:41:58 PM CEST · Helmut Koenig (II) · Participant "Helmut Koenig (II)" added OK: Abstain
- 4/20/10 7:55:59 PM CEST · Joy Kuhl (Child Health) · Participant "Joy Kuhl (Child Health)" added OK: Abstain
- 4/29/10 3:12:57 PM CEST · Austin Kreisler · Poll closed by "Austin Kreisler"
- Rita Altamore (PHER) April 16, 2010 4:18:22 PM EDT - PHER discussed the scope statement during its 4/16 call and agreed that we would like to see it include reference to and harmonization with the Common Product model work, and collaboration with OO.
- Email thread:
I agree with Austin that you really want to run these ideas past the work group. I did notice, however, at least one name of someone that was familiar with the common product model, so I am hoping it is not a hard sell. Note, also that there are people associated with the Global Health Task Force already looking at the ICSR.
At the end of the day, it is going to be really important for the proposed DAM and the CPM to be consistent with each other.
Original Message -----
From: "Kreisler, Austin J." To: Williamtfgoossen; dmead; domainexperts Sent: Tuesday, April 06, 2010 12:36 PM Subject: RE: Project Scope Vote: Patient Care DAM and DCM for Medical Devices
You will probably want to make sure that your work group is comfortable with the change. How you manage that is dependent on Patient Care's decision making practices and not really for the steering division to dictate. We can let the DESD vote continue while you sort out with Mead and your work group the exact wording changes to the project scope statement. Once that's done, I can distribute that updated copy.
Making these sorts of changes to a project scope is part of the steering division process for approving them. What each work group needs to decide is how they are going to react to the changes made during the steering division project approval process. That's the part we can't dictate. Work groups sponsoring a project obviously have to agree to changes to the project. How a work group manages that may be as simple as the co-chairs of the work group deciding or as complex as a work group withdrawing the scope from the steering division vote while the scope statement is revised, or anything in between.
From: Williamtfgoossen Sent: Tuesday, April 06, 2010 12:13 PM To: dmead; Kreisler, Austin J.; domainexperts Subject: Re: Project Scope Vote: Patient Care DAM and DCM for Medical Devices
In a message dated 6-4-2010 16:33:08 W. Europe Daylight Time, dmead writes:
Thanks for circulating this interesting proposal.
I would like to see two changes:
1. The addition of the Patient Safety Workg Group as an co-Sponsor Even though the work group comes into the process of device informtation at the end of the day - when things go wrong - it has already done a considerable amount of modeling in this area.
2. Mentioning the need to ensure coordination/harmonization with the Common Product Model which is the place where the information specific to the device - as opposed to using the device on a patient - is (and should continue to be) housed.
As the forefighter for harmonisation I can agree to Meads proposals. However, is it enough to state this, or do we need to update the proposal document and go back to PC WG for approval?
I am just not sure about the next steps / duties I have with such a change.
Met vriendelijke groet, Results 4 Care b.v. dr. William TF Goossen directeur