How Often Should Medical Devices be Checked?

All medical devices are given an inspection interval by the manufacturer. Most commonly this interval is 12 months, but it could be 6 months, quarterly, every other year or run-to-fail. Usually the device catagory is determined by the FDA and its inherit risk, with Class I devices deemed the lowest risk therefore subject to the least regulatory controls. Class III devices have the strictest regulatory controls and are considered life safety devices. Life safety devices will typically have a 6 month windows with included output testing (i.e. Manual Defibrillators, Electical Surgical devices- Bovies, etc...) In review, the OEM (Original Equipment Manufacturer) will determine the scheduled testing interval for the specific model of device. The present trend is for ALL devices to be checked at least annually. Some devices will fall under stricter rules (i.e Labs following CAAP accredidation guidelines) that mandate shorter testing intervals along with documented outputs on devices, such as centifuges under CAAP or devices handling blood products subject to NY DOH rules. The testing frequency can always be increased, or done more often, but the OEM interval should always followed at a minimun.