🔥 Find me at MedicalDevicesGroup.net 🔥
4 min reading time
As originally asked by Jose Luis Maglione.
There seems to be two parts to this discussion. The first is setting the calibration recall intervals for existing equipment in use, while the second seems to be setting the manufacturer’s recommended recall interval for a newly designed piece of equipment.
For the first case, most locations follow the manufacturer’s recommendations. There are also statistical methods, time series, to estimate drift and predict when the instrument will go out of calibration. There is a simple method called stair-step. Start with, say, a 12 month recall interval. If the equipment is in specification at the next calibration, extend the interval by one month. If the equipment is out of calibration (or nearly so) shorten the interval by one month.
For the second case, you do not need real time tests. You could do a stability analysis on the circuit. You could do a time series analysis, taking readings frequently to predict drift. You could combine the time series with an acceleration factor, such as temperature, to predict drift.
If you are setting calibration recall intervals for a new medical device, don’t forget to include it in your design validation under 820.30.
Here is another group. Biomedical Test & Measurement Equipment; [https://www.linkedin.com/groups?home=&gid=2464195&trk=anet_ug_hm|leo://plh/https%3A*3*3www%2Elinkedin%2Ecom*3groups%3Fhome%3D%26gid%3D2464195%26trk%3Danet_ug_hm/d8eO?_t=tracking_disc]
Jose Luis Maglione
I know there is also the International Bureau of Weights and Measures. I don’t know if every individual country has their own counterpart.
Obviously some equipment, especially any high power measurement equipment, would be more critical and some may even require a shorter calibration interval but here in the US the general guideline is one year. This goes for ECG simulators, Defibrillator Analyzers, Pulmonary Function analyzers, ESU and NIBP testers Ultrasound Watt Meters and so on. With some equipment such as signal generators of various types it is probably rare that they would be out of calibration but they are still required to be checked. Back in the old days when a lot of discrete components and manual calibration potentiometers were used it was a different story and calibration intervals were shorter as well. Nowadays a lot of test equipment as well as medical equipment goes through its own self calibration routine but periodic PM and Calibration testing is currently still required.
Marked as spam