Why FDA compliant?

I had a call the other day from a client who was planning to buy low beds.  They were asking me,  "Do electric health care beds have to be FDA compliant and doesn't that make them cost more?"   

It was an interesting question because there are so many underlying issues involved.  I started to give the client the "regulatory" answer until I realized that they were really asking me to respond to the cost/value part of their question.  I told them, "The bottom line is that. yes! You will probably pay more for an FDA certified bed because of the design and testing requirements but you would want to buy certified products for your own protection.  I'll explain further. 

First, here's the boring part: Health care beds fall under MEDDEV 2.4/1 -rev. 8 Part 2,Rule #12 for Class 2 "active medical devices".   The IEC 60601 / UL 60601 Type B rating is the concensus standard for these beds and is recognized by the FDA.  There are only about eight laboratories in the entire world that are approved by the FDA to test products to these standards.  That's why it adds to the cost of the beds. 

I could go on with the regulatory details but suffice to say that there is a long litiguous and specific history which implies that a prudent operator ONLY utilize certified beds or other medical devices in their facility.   

The immediately obvious benefit to FDA certification is safety.  Complying with the IEC 60601 / UL 60601 standard shows that the device is 1. not likely to catch fire 2. not likely to shock the resident or the staff 3. not likely to entrap the resident 4. not likely to collapse or in some other way fail. 

Notice that I used the term "not likely" in the paragraph above.  Even though a bed is tested to the 60601 standard, it does not guarantee the QUALITY of the product.  That is why we have incident reports and recalls ... and yes, there have already been some 13 hospital bed recalls this decade. 

Some manufacturers might use the fact that their bed met the UL 60601 standard to IMPLY that they sell a superior product.  Not so!  It is POSSIBLE to build a really cheap bed that meets the 60601 standards.  Of course that bed will also probably fail very early in its life cycle.  The real test for bed safety and longevity is the documented reporting of serious incidents that occur relative to each bed.  To provide that reporting it is the responsibility of every health care operator in the United States under the Federal "Medical Device Reporting Act".  The FDA publishes these reports in what are called the "blue sheets".  So, an older style bed, certified to a previous 60601 standard, is no less credible than a brand new bed certfied to a newer standard if there have been no incidents reported on that bed.  The proof is really in the operation and use of the product. 

This leads me to the second, and less obvious benefit of a certified bed.  The certified bed is subject to an FDA notices and re-calls.  This notification program alerts the buyer to problems with the bed and, under the law, gives the buyer recourse to re-coup his costs of repair or replacement. 

A final benefit I want to point out in this article is that of your liability.  Every lawyer will tell you that if you utilize a "consensus certified" product and a serious incident occurs in your facility, your liability is somewhat mitigated.  If you choose to use an un-certified product or a non consensus standard, your liability can escalate dramatically.  Referencing my earlier paragraph highlighting the incidents that "MIGHT NOT HAPPEN", no matter how good the product is, these bad things might happen.  I am only confident that they are less likely to happen to you if you choose a certified bed.   

So, in summary, if you are thinking of buying any un-certified medical device for your facility because of a perceived cost savings, I recommend that you have a long and serious talk with your risk management and legal departments before you make the purchase.