Activist group Public Citizen, in a petition filed July 6 with the Food and Drug Administration, alleged that Med-Safe Systems Inc. intentionally manufactured its Guardian sharps collectors to a thinner specification than it had promised both the FDA and its customers. A spokesman for Oceanside, Calif.-based Med-Safe, however, said July 18 there is ``no truth to the allegations'' - which he attributed to a disgruntled former employee - that the company was negligent in making the injection molded polypropylene containers.
At the same time, Public Citizen charged a Med-Safe customer, Becton Dickinson and Co. of Franklin Lakes, N.J., with failing to recall the allegedly too-thin plastic containers from consumer use once it discovered the alleged flaw. Becton Dickinson agreed July 17 to exchange suspect containers if customers are concerned about the thinness of the Guardian sharps collector's walls.
A Becton Dickinson spokesman said no recall initially was issued because the company determined that injury was unlikely to occur if the containers were used as their printed instructions directed.
Tony Saenz, manager of regulatory compliance for Med-Safe Systems, said that the FDA will judge the whistleblower's charges of negligence to be unfounded.
Saenz said sharps containers are the major product manufactured by the company.
Most injuries that result from needle punctures result from misuse of the collectors, such as overfilling, rather than from a needle piercing the container, Saenz said.
Neither Saenz nor Public Citizen said any puncture injury had been attributed to a used needle penetrating a too-thin wall in a Med-Safe device.
The charge came from a ``disgruntled employee who had been dismissed for negligence on the job,'' Saenz said, adding the allegations arose from ``a product problem that was corrected and addressed.''
Public Citizen's petition contends that between August and December 1994, Med-Safe had manufactured the collectors with wall thicknesses of 0.028 inches rather than the 0.05 inches it had specified to Becton Dickinson.
Julia Lyman, a Public Citizen spokeswoman, said about 500,000 Guardian containers were manufactured during that time, and that Becton Dickinson returned about 125,000 to the manufacturer from Becton's stock.
Public Citizen's petition letter noted: ``A Med-Safe employee notified Becton Dickinson of Med-Safe's gross production irregularities. Becton Dickinsonreturned unused sharps collectors from this period to Med-Safe but failed to recall those that had already been shipped to customers.''
Neither Public Citizen nor Med-Safe would identify the employee in question.
But Peter Lurie, a University of California at San Francisco health researcher who brought the Med-Safe allegations to Public Citizen, said through the interest group that ``internal company records reveal that Med-safe suspended record keeping for testing procedures during much of this period, presumably to prevent a paper trail documenting the substandard wall thickness.''
Med-Safe refused to comment on that allegation.
Public Citizen called for criminal charges against the manufacturer, but an FDA spokeswoman would not discuss particulars pending an investigation.
``We received the petition from Public Citizen. We're looking to see if it is as serious as they say it is,'' said spokeswoman Sharon Snider. ``We're moving as quickly as we can.''
Snider did not know if a minimum acceptable wall thickness of the sharps collector container is mandated under federal law or regulation, or established by a manufacturer's estimate. Lurie, however, noted no federal requirement exists mandating either the wall thickness or the type of resin that should be used in the manufacture of such containers.
The Public Citizen petition noted, ``This incident underscores the need for more stringent regulation of medical de-vices and illustrates the dangers of the deregulatory measures currently under consideration, which would increase the likelihood of similar problems occurring.''