A Medical Device Daily
Stryker (Kalamazoo, Michigan) said last week that it has recalled 322 custom-made cranial implant kits because of possible sterility issues, which the FDA advised could be lethal.
The company recalled all kits distributed between Nov. 5, 2007, and Oct. 23, 2008, because it can't be sure the kits were properly sterilized. Physicians received a recall letter Oct. 24, and the FDA last week deemed the recall a Class 1, meaning there is a reasonable probability that use of the product will cause serious injury or death.
Physicians who used the implant kits were advised to follow up with patients for at least six months after surgery to check for infections. The letter also told patients how to identify and return any remaining implant kits. The cranial implant kits are used to correct defects in the jaw and face, or cranium and face.
The implants were apparently designed by and manufactured for Stryker by Contract Medical Manufacturing (CMM; Oxford, Connecticut).
A Nov. 20 warning letter to CMM indicated problems with the company's sterilization of customized cranial implants that were sufficient to prompt the company to place a hold on the implants "until further notice," according to the warning letter (Medical Device Daily, Dec. 18, 2008).
According to FDA, the September inspection disclosed that CMM could not document that the company had validated the package-sealing process or the sterilization process for the implants. The letter states that the company suspended shipments on Sept. 16 and that it would initiate a recall of "all sterile custom cranial implants manufactured by CMM."
FDA noted that it "look[s] forward to reviewing the completed documentation process" for the sterilization validation, but indicated that the company's response to the inspectional form 483 "did not address ... the seal integrity process."
FDA cited the company for monitoring the humidity in the room in which ethylene oxide (EtO) sterilization was taking place rather than the humidity in the autoclave. This citation for environmental monitoring also notes that CMM "was not maintaining or reviewing the temperature recording charts" generated during sterilization procedures.
Utility seen in early Medicare buy-in
A detailed report issued by the Congressional Budget Office (CBO) comparing healthcare reform options found that a plan to allow Americans to buy into Medicare before turning 65 would lead to more people with health coverage and lower costs than private insurance coverage.
The CBO studied a limited Medicare buy-in option for those between 62 and 64. The CBO estimates that the annual premium for single coverage in 2011 would be about $7,600, including drug coverage. In comparison, a private insurance policy premium for a 64-year-old can easily cost $12,000 to $16,000 a year, not including co-pays and deductibles and after excluding coverage for those with even minor health problems.
In 2006, Medicare spent about $10,200 on average per beneficiary, which currently includes an older and sicker population than that envisioned by the buy-in program.
"The report emphasizes an important point for policy makers to keep in mind as they grapple with fixing our nation's healthcare: Medicare provides more affordable coverage because it eliminates the waste and profiteering of the private market," said Jerry Flanagan of Consumer Watchdog (Santa Monica, California). "Polls show that seniors are also happier with their coverage than those of us with private insurance policies because they have better access to healthcare."
The CBO report did find that the Medicare buy-in program would lead to higher-than-expected Social Security payments because, due to the program, more Americans over 62 would retire earlier than without the program.
Consumer Watchdog said those expenditures, which the CBO found would be "minimal" over the long term, could be erased if the program were expanded to allow any American to buy in to Medicare regardless of age.
If Medicare also covered the young, the estimated cost per person would plummet. Children in federally subsidized plans cost about $2,300 a year (including dental), and younger adults fall in the middle.
Roughly 34.7% of Americans (89 million people) under the age of 65 did not have insurance for some part of the year during 2006. About 10 million to 14 million people currently purchase individual insurance policies.
Consumer Watchdog said these 100 million Americans would benefit from a low-cost, high quality public option to the private market, no matter what the level of subsidy. Allowing employer groups to join the public purchasing pool over time would further maximize cost savings.