Repairability Index Labeling for Medical Imaging Devices
G. Wayne Moore
08/10/2021
A new wrinkle in the right-to-repair medical devices is brought to us courtesy of the General Assembly of Pennsylvania, House Bill No. 1757, Session of 2021, known as the Repairability Index Act (RIA). The RIA offers no product exemptions and states, in part, “For digital electronic equipment sold or used in this Commonwealth, original equipment manufacturers shall make available, for the purposes of diagnosis and consumer information, a repairability score for the following categories.”:
- Duration and availability of technical documents and related advice on the use and maintenance of the digital electronic equipment (DEE)
- Ease of dismantling, tools required, and other characteristics of the fasteners used, or other parts
- OEM’s estimation of the duration of parts for the product
- The amount of time the OEM plans on manufacturing replacement parts for the DEE
- Price ratio of replacement parts to the price of new equipment
- Potential to recycle or dispose of the DEE
- Expertise required to safely effect the repair
- And any other information deemed necessary by the Attorney General
“The OEM shall compile the average repairability score. The average repairability score shall be the average of each score criteria for the categories listed above.” The scoring ranges from 1 to 10, with 1 being the worst and 10 being the best. This type of index is being tried in France with consumer electronic products, not medical devices, with a focus on self-repair (i.e., non-experts with no specific repair skills), not commercial repair (i.e., performed by an expert repair technician). Among the myriad problems with trying to mandate this repairability index on medical devices, I submit two: (1) An iNEMA report that assessed the type and quality of metrics available to the electronics industry concluded that “there are no agreed upon, quantifiable sets of metrics or tools to measuring an electronic product’s true ‘repairability.’” (2) OEMs will be self-reporting these numbers, therefore the score would be developed without the guidance of a quantitative standard. Because of that oversight, the self-reported number from a Siemens medical device would not be comparable to a self-reported number by GE, Philips, or any other medical device OEM. Simply put, that type of number would have no value to the healthcare consumer or decision maker.
This Bill is totally misguided when it comes to medical devices, which should be exempted. The American journalist, HL Mencken, was once quoted as saying, “for every complex problem there is an answer that is clear, simple, and wrong.” This Bill is not only wrong, but it also does nothing more than distract from the broader medical device R2R debate.
Until next month,
G. Wayne Moore, B.Sc., MA, FASE, FAIUM