Outsourcing to another facility

[diana_mssc]

I have recently been approached by another clinic that has no sterilizing capabilities. They have asked if our surgery center can do "a few peel packs" for them and they would compensate us. Are there any estabilished policies regarding this sort of thing? As I understand it, we would be liable for the sterility of their instruments. Is there a way to word the contract between the two facilities so that they release us from liability? I'm curious about the legality of this. Any information or direction to information about this issue would be extremely helpful. Also, does anyone know if any local (to California) companies that do sterilization outsourcing? Perhaps it would be better to direct the other facility to them. Thanks, Diana

[Harvey Johnson]

We do low volume peel pack sterilization for our off site clinics and the local life flight air ambulance group.
Our agreement states, as we cannot control the handling or storage of peel packed sterilized items after they leave our department, we can only guarantee parameters have been met for sterilization at the time the items are retrieved by the customer. (we seal packages in dust covers for transport)
Upon verifying the visible integrators and receiving the package, the customer at that time accepts all responsibility and liability for maintaining sterility of the items outside of our Department.
Probably best to check with your Director and Risk Manager.

[chipmoore]

Hello everyone, I think the discussion of a healthcare facility "manufacturing" sterile devices for an operation not under the facility's corporate umbrella, has been discussed previously. To make it short, the FDA does not regulate hospital sterilization, only those "manufacturers" who place products labeled as sterile into commerce (revenue gain). If you "sell" a service or actually produce sterile product for financial gain, you are considered a Medical Device Mfg and thus subject to the full regulatory requirements. SPD Soup last line is a good one and I would add your legal beagles too.
Chip Moore
Rochester, NY
Retired but involved

[Harvey Johnson]

Good point, Chip.
I assume the FDA regs are in place to protect patients and regulate against fly by night folks who may claim to have sterilization services.
Are you certain the example given applies as there are quite a few hospitals out there sterilizing for off site facilities which in turn are "billed" from their budgets for the sterilization services.....no revenue gain, just costs incurred. How about if a neighboring hospital needs assistance when their only eto or plasma machine goes down and offers to reimburse us the costs (again, no revenue gain) of processing their items until it is repaired?
If these issues run contrary to FDA regulations I think it would have been addressed by now......I know information is slow to reach us out here on the coast, if you have a web site to reference, we would appreciate it.
As you stated, everyone should be very careful to check out all the possible legal ramifications when contracting with an institution outside of your hospital's control, especially if it involves the Feds!!
Thanks again for the information.
See you in Reno!
Harv

[chipmoore]

Hello,
I think the test or benchmark would be deciding if the arrangement is defined as placing a product labeled as sterile into commercial distribution (inter or intrastate). If the answer is yes, the FDA would be interested.
Arrangements within a healthcare organization would not be considered commercial distribution, in my opinion. Trading services to keep a facility running wouldn't be either. The FDA/CDRH web site has tons of info regards Medical Devices and the steps required.
The time to Reno is getting shorter and I'm looking forward to it and meeting the attendees, hope to put names on many faces during my stay.
Chip Moore
Rochester, NY
Retired but involved

[diana_mssc]

thanks for all the info. this has definitely been useful in helping me make a decision for our facility.