Have you ever treated patients in a clinic or even your own office and not known or not recorded what dental products you were using? Have you ever wondered what you would then do if a patient had a reaction to one of these unknown products, or if a product you might have used was recalled by the manufacturer (it does happen!)? If the brand name of the dental product were not in the written record and an incident occurred some months or years in the future, it would be nearly impossible to go back to document the situation with certainty, enough to satisfy a plaintiff’s litigator and a jury.
I see two major problems in the way dentists use modern clinical materials:
- – unit dose products are rarely labeled to show what they are (such as dental amalgam prepackaged capsules);
- – dentists usually don’t record the brand name of the products they use. Improper written notes often doom legal cases because of their brevity or imprecision.
Both problems could be solved if manufacturers voluntarily placed a peelable identification label on each unit-dose capsule or container and supplied a roll of peelable labels with all other products that are dispensed from tubes or other forms of packaging.
The dentist or staff member would simply peel off the label and place it in the patient’s written record, permanently documenting the actual products used during treatment and lessening the requirements for handwritten details. This also would include dental products such as impression materials, which occasionally are trapped in the tissues or dissect into fascial planes in the mouth.
Similarly to the ongoing Identalloy labeling program for casting alloys, the somewhat smaller labels would contain the manufacturer’s name and logo, product name, International Organization for Standardization material type, ADA Seal of Acceptance as appropriate, composition, hazardous elements if any, and packaging and expiration date. Small labels containing this information already are attached to anesthetic carpules, which should also be peelable. Bar coding also is possible on these labels.
Such labeling would fulfill the patient’s right to know and satisfy possible forensic requirements. It would constitute free advertising and permanent documentation for manufacturers of name-brand materials, distinguishing them from me-too or cut-rate products. The U.S. Food and Drug Administration is now proposing new packaging and labeling guidelines for dental products; it is time to do it right.
We must be accountable for the materials and products we use on patients, just as hospitals and pharmacies establish a paper trail for every drug they dispense. This should be our standard of care. Dental patients deserve no less.
