MITA's remanufacturing white paper recalls 'Groundhog Day' movie: IAMERS
February 13, 2019
An editorial by Robert J. Kerwin
MITA recently released a white paper entitled "Considerations for Remanufacturing of Medical Imaging Devices". No doubt, its release is in anticipation of the FDA deadline this month for providing comments pertaining to the guidance FDA is preparing on the definitions of remanufacturing and servicing. It is well written and offers additional confirmation (if we were in doubt) of MITA’s position that there is “a lack of consistent regulation and discretionary oversight of the medical device servicing industry”.
MITA’s conclusion as to a lack of consistent regulation and discretionary oversight is a conclusion with which I agree, but for very different reasons and attributions. Each month I hear about instances where a manufacturer, with apparent impunity, withholds adequate instructions, service keys and information important to calibration. Since most diagnostic imaging manufacturers have extensive multi-vendor programs, "what goes around comes around", as the manufacturer may experience another manufacturer’s withholding of adequate information.
Indeed, I still chuckle about when I was asked to provide a manufacturer with copies of the FDA letter, which affirms the necessity of providing A.I.A.T. information. Note: I did forward the letter and envisioned it must have been a sweet moment when the manufacturer (who has withheld information), was reminding another manufacturer of the need to provide A.I.A.T. information. But I digress.
The white paper concludes with a proposed solution concerning the adoption of quality management systems which is sufficiently robust and adequately scaled to “ensure that servicing and remanufacturing activities are properly performed, documented and regulated”. Since a number of IAMERS members have voluntarily obtained ISO 13485 or 9001 certification, this is also a general premise upon which I am loathe to disagree. However, as they say, its all in the details.
Reading further in the MITA white paper, it brings to mind one of my favorite movies, "Groundhog Day". You may recall this 1993 comedy fantasy film starring Bill Murray as Phil Connors, a TV weatherman who, during an assignment covering the annual Groundhog Day event is caught in a time loop and forced to repeatedly relive the same day celebrating Punxsutawney Phil as a predictor of a long winter.
It just seems that we are back in 2015, when MITA was presenting to the FDA on "Observations on Lack of Uniform Performance". MITA notes a lack of uniform regulatory oversight of all servicing providers. A similar argument was advanced when a MITA representative testified before Congress on pending legislation.
Nowhere in the white paper does MITA provide support for its claim of an increased "risk to the public health." As MITA once acknowledged in its previous submission to the FDA it is impossible to provide a statistically valid analysis of the extent of problems.
MITA should maybe take a little guidance from Groundhog Day with respect to its white paper. Phil Connors was eventually able to get out of the time loop by adopting a new attitude which truly focused on improving the lives of those around him (movie spoiler: saving a boy falling from a tree, helping a restaurant patron choking and fixing the flat tire of elderly ladies etc.). Accordingly, perhaps adding some manufacturer responsibilities, can assist this recommendation:
Is it really enough to simply say one needs a robust QMS? Remember the final lesson of GroundHog Day: Phil was finally able to succeed in escaping the time loop and getting his love interest Rita to truly appreciate him after he started doing things to support the community.
About the author: Robert J. Kerwin is general counsel for IAMERS, the International Association of Medical Equipment Remarketers and Servicers.
MITA recently released a white paper entitled "Considerations for Remanufacturing of Medical Imaging Devices". No doubt, its release is in anticipation of the FDA deadline this month for providing comments pertaining to the guidance FDA is preparing on the definitions of remanufacturing and servicing. It is well written and offers additional confirmation (if we were in doubt) of MITA’s position that there is “a lack of consistent regulation and discretionary oversight of the medical device servicing industry”.
MITA’s conclusion as to a lack of consistent regulation and discretionary oversight is a conclusion with which I agree, but for very different reasons and attributions. Each month I hear about instances where a manufacturer, with apparent impunity, withholds adequate instructions, service keys and information important to calibration. Since most diagnostic imaging manufacturers have extensive multi-vendor programs, "what goes around comes around", as the manufacturer may experience another manufacturer’s withholding of adequate information.
Indeed, I still chuckle about when I was asked to provide a manufacturer with copies of the FDA letter, which affirms the necessity of providing A.I.A.T. information. Note: I did forward the letter and envisioned it must have been a sweet moment when the manufacturer (who has withheld information), was reminding another manufacturer of the need to provide A.I.A.T. information. But I digress.
The white paper concludes with a proposed solution concerning the adoption of quality management systems which is sufficiently robust and adequately scaled to “ensure that servicing and remanufacturing activities are properly performed, documented and regulated”. Since a number of IAMERS members have voluntarily obtained ISO 13485 or 9001 certification, this is also a general premise upon which I am loathe to disagree. However, as they say, its all in the details.
Reading further in the MITA white paper, it brings to mind one of my favorite movies, "Groundhog Day". You may recall this 1993 comedy fantasy film starring Bill Murray as Phil Connors, a TV weatherman who, during an assignment covering the annual Groundhog Day event is caught in a time loop and forced to repeatedly relive the same day celebrating Punxsutawney Phil as a predictor of a long winter.
It just seems that we are back in 2015, when MITA was presenting to the FDA on "Observations on Lack of Uniform Performance". MITA notes a lack of uniform regulatory oversight of all servicing providers. A similar argument was advanced when a MITA representative testified before Congress on pending legislation.
Nowhere in the white paper does MITA provide support for its claim of an increased "risk to the public health." As MITA once acknowledged in its previous submission to the FDA it is impossible to provide a statistically valid analysis of the extent of problems.
Robert J. Kerwin
- Perhaps they could have included in the white paper an affirmative duty of the manufacturer to provide "adequate instructions"?
- How about if there are specifications or performance standards, or components that would only be measured or quantified during the course of scheduled maintenance, requiring the manufacturer to provide this information?
- If there are specifications available for component replacements, why not ask the manufacturer to share this information? Why not ask the manufacturer to routinely disclose, for parts and components, the preventive maintenance instructions, especially for those parts or components that may experience measurable degrees of wear?
- If the manufacturer requires custom test equipment to calibrate or service an imaging system, shouldn’t that testing equipment be made available for sale?
Is it really enough to simply say one needs a robust QMS? Remember the final lesson of GroundHog Day: Phil was finally able to succeed in escaping the time loop and getting his love interest Rita to truly appreciate him after he started doing things to support the community.
About the author: Robert J. Kerwin is general counsel for IAMERS, the International Association of Medical Equipment Remarketers and Servicers.