SQF Code 13.3.3.6 - Smartwatch used for medical condition
We have an employee that has a medical need to wear a smartwatch to monitor the heart/pacemaker. Would the wearing of this be considered within the intent of the code as a "medical alert bracelet"? Would we need to include a specific statement in our jewelry policy? Thanks in advance for your thoughts.
13.3.3.6 Jewelry and other loose objects shall not be worn or taken into any area where raw and packaging materials, work-in-progress, or food sector packaging is exposed. Wearing plain bands with no stones and medical alert bracelets that cannot be removed can be permitted; however, the site will need to consider their customer requirements and the applicable food legislation.
Bear in mind smart watches are fairly recent tech and haven't saved lives to my knowledge yet...
It could be there are other ways to monitor and for some things they're pretty inaccurate. I'd ask an occupational health professional to support.
And an aside. If someone has a pacemaker you need to do a magnetic field assessment. That could be far more dangerous than not wearing a smart watch to the employee.
Do they have a note from a doctor stating they need to wear their smart watch at all times? This sounds like horse puckey. There's other ways to monitor as GMO stated. You're not just letting a bracelet in, you're letting glass in via the watch face.
I'd be a hard no personally.
I'm not aware of any commercial smartwatch that has a medical device certification behind it (happy to be proven wrong if someone has seen one). I'd want to have a doctor's note on file, and I'd be moving the employee to a position where they aren't handling exposed food. Letting them keep the watch on and covered by a glove is a gray area that I'd be way too lazy to wade into to try and fight with an auditor or regulator.
A smartwatch does not qualify as a medical alert bracelet (MAB). A MAB is usually made of one single material, does not pose a glass/brittle breakage risk, and is metal-detectable. Plus they can also be worn around the neck (necklace version) or ankle if wearing a bracelet is a food or occupational safety hazard.
The smartwatch also does not qualify as a medical device. Section 201(h) of the FD&C Act give a broad definition; a medical device is “any instrument, machine, contrivance, implant, in vitro reagent that's intended to treat, cure, prevent, mitigate, diagnose disease in man”. However, the smartwatch device isn't manufactured with the intention to do any of that, and any health/wellness app itself likely has a disclaimer stating it is not to be used to "treat, cure, prevent, mitigate, or diagnose disease."
The only FDA-recognized smartwatch feature I know of related to monitoring heart health is the Samsung Galaxy Smartwatch with IHRN feature. And that device is only recognized with low-level FDA-clearance (affirmation that device is safe and effective), and does not have FDA-approval (approval after device meets required clinical testing).
On a personal note: I have 2 close family members with pacemaker devices, and while there is an app, they have described it as "basically useless." And in the decade since smartphones became a thing, no doctor has ever recommended they monitor their heart health with an app.
If the employee absolutely *must* wear the smartwatch, you could try moving them into a location where there is no raw material or exposed food. If that's not possible, consult with Human Resources regarding reasonable accommodation under ADA and figure out if you might need to take other actions.
To clarify, the employee is not assigned to the manufacture of food packaging, rather a member of the senior management team. The interaction with production is management by walking around. The watch is only to self-monitor conditions. Thanks for the responses.
If it's worn by a member of management and the contact will be minimal or for very short periods of time, they should be able to take it off for a few minutes or you could do a RA and determine if it would actually be a risk for the duration and contact it would represent.
I wouldn't push this one
My guess is the pace maker has an app (like everything else does) and that persons welfare is obviously important
Have a frank conversation with them to determine if they are comfortable removing it for the duration of the floor visit if not, risk assess away