FDA Warning - DST Might Create Problems For Medical Equipment | Designated Representative and Exemptee

Tuesday, March 16, 2010

FDA Warning - DST Might Create Problems For Medical Equipment

Trusted FDA CGMP online training courses offered by SkillsPlus International Inc.

Updated November 29, 2025:

The original link broke.

You can still read something that's related here:

FDA Concerned About Impact of DST Change on Devices - MDDI

--- the original post follows below ---

When I went to work yesterday, under Daylight Savings Time, my meeting times for recurring meeting times in a popular web meeting software application were inconsistently wrong. Now apply the time change problem to medical devices.

The FDA advises in, Advice for Patients: Change in Daylight Saving Time May Affect Your Medical Equipment in an Unpredictable Way:

"If you have any medical equipment that uses, creates or records time information about your diagnosis or treatment and the manufacturer has not updated it, the equipment may not work properly when Daylight Saving Time (DST) starts and ends."

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1 comment:

Austin LeeNovember 29, 2025 at 5:34 AM
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Glossary - Exemptee & Designated Representative

Computer Based Training (CBT): This is closely related to other e-learning or eLearning terms, such as: online training, web-based training (WBT), internet-based training (IBT), digital training, virtual training, e-training (technology based traiing, TBT). e-learning refers to all forms of electronically supported learning and teaching.
Designated Representative: A California designated representative is an individual who performs clerical, inventory control, housekeeping, delivery, maintenance, or similar functions related to the distribution or dispensing of dangerous drugs or dangerous devices.
Designated Representative-3PL: An individual approved by the board to provide sufficient and qualified supervision of a third-party logistics provider’s place of business. The designated representative-3PL shall protect the public health and safety in the handling, storage, warehousing, distribution, and shipment of dangerous drugs and dangerous devices. (CA BOP).

Designated Representative-Reverse Distributor: An individual to whom a license has been granted pursuant to Section 4053.2, who is responsible for supervision over a licensed wholesaler that only acts as a reverse distributor (CA Board of Rx - Desig Rep RD).
DRIC: Designated Representative In Charge (DRIC)
e-Learning: Also referred to as eLearning. A wide set of applications and processes, such as Web-based learning, computer-based learning, virtual classrooms, and digital collaboration.
Exemptee: A California exemptee is an employee that meets the required knowledge and training mandated by California Health and Safety Code 111656.4.
HMDR: Home Medical Device Retailer (HMDR) Licensing Program. This Program licenses all California and Out-of-State facilities and businesses who supply medical devices or durable medical equipment for use in the home to treat acute or chronic illnesses or injuries.
Manufacturer: California law defines a “manufacturer” as any person who prepares, derives, produces, compounds, or repackages any drug or device except a pharmacy that manufactures on the immediate premises where the drug or device is sold to the ultimate consumer. (B&P § 4033(a), (b), (c); see also H&S § 109970.)
NCDQS: At the National Coalition for Drug Quality & Security (NCDQS), our accreditation programs for wholesale drug distributors go beyond the most stringent state and federal regulations to include best practices in maintaining the quality and security of drug products.
SOP: SOP is the abbreviation for Standard Operating Procedures. Both the Board of Pharmacy and the HMDR require SOPS.
VAWD: The Verified-Accredited Wholesale Distributors (VAWD) accreditation is for facilities engaged in the act of wholesale drug distribution. The VAWD program has been rebranded as the "NABP Drug Distributor Accreditation" program.; Under California law, a “wholesaler” is any person who acts as a wholesale merchant, broker, jobber, customs broker, reverse distributor, agent, or a nonresident wholesaler, who sells for resale, or negotiates for distribution, or takes possession of, any dangerous drug or device. (B&P § 4043(a).)

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Tuesday, March 16, 2010