It appears to be happening again. The government is riding in on a white horse it calls patient safety to saddle us with regulations that don't make sense in the real world of ophthalmology. The FDA has issued a new set of rules that govern the reuse of disposable devices.

For now, the rules are aimed only at hospitals and companies that reprocess single-use devices (SUDs), but comments from FDA officials and our past experiences in similar situations leave little doubt that they will eventually be applied to ambulatory surgery centers (ASCs) as well.

The rules are onerous; hospitals will have extreme difficulty complying. And the cost of compliance would force ASC owners to discontinue reuse altogether. This would rob ophthalmic surgeons of one more way to function cost-effectively, which in the long run benefits patients and the profession as a whole. Doctors who can't turn a profit abandon all but the simplest of care. Future advances are stifled. Furthermore, rather than prompting surgeons to buy a new disposable device for each case, the result of the regulations would be a widespread preference for nondisposable devices and a subsequent loss of market share for SUD manufacturers. So, nobody really benefits.

Laws should be backed by logic

No doctor would say that ophthalmology should be free of regulation. But it's true that some devices labeled "for single use" can be cleaned, sterilized and reused with no detrimental effects on patients. This is what makes the current regulatory effort misguided -- it's being mounted by entities who have little understanding of what they're trying to regulate. It's reminiscent of the unnecessary pre-op medical testing that was being done for cataract surgery in the past. The government was spending, by conservative estimates, $250 million a year for something that has been proven to provide no benefit to patients. Standard of care -- or worse yet, laws -- should never be established based on nothing more than medical custom or a knee-jerk reaction to a perceived problem. We can't afford that in these cost-conscious times.

For guidance on the issue of reuse, we should be turning to leaders in ophthalmology, organizations such as ASCRS, OOSS, ACES and the AAO, who understand the issues involved and can help regulators comprehend that when it comes to government interference in the delivery of medical care, less is more