Q: What does your department do to prepare for Daylight Saving Time (or any time change)? What is the most efficient way to set clocks on multiple devices?
A: Our facilities developed a staffing plan for Daylight Savings using HTM paid “volunteers” to work the required time to ensure appropriate time changes. The amount of staff varies based on the volume of non-networked mission critical devices, such as defibrillators. Most of our networked medical devices are pointed to NTP servers. The NTP server is necessary because of our integration with the electronic medical records (EMR). The EMR requires medical device results to be validated, therefore the time of the physiological data acquisition must nearly match the time stamp in the EMR. The EMR allows a refractory period due to potential network latency. Therefore, for Daylight Saving Time changes, the medical device server is always synchronized with the NTP server and time is updated by the appropriate servers on the network, such as a patient monitoring system. For situations of non-networked medical devices, such as a defibrilator, these devices must be manually updated by the HTM professional. The HTM professional validates networked and non-networked device time changes, hence the need for on-site labor. Work orders in our CMMS product are opened for all the devices that require time validation and then the work orders are closed once the time is validated by the on-site technologist.
A: Most our devices are connected to our internal network. Thus, we configure NTP. The time on each device is synced to the NTP server. Thus, we do not need to adjust the time except some units that are not connected.
Q: Does anybody have a policy on blanket warmer temperature settings for neonate patients?
A: The IEC 80601-2-35 Standard (Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use) does not differentiate ages in the operational temperature limits of blankets and warmers. But it has different limits depending on the type of warmer. In my procedures, I’ve set the maximum temperature in infant warmers at 40°C.
IEC 80601-2-35-basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use
201.11 Protection Against Excessive Temperatures And Other Hazards
201.11.1 Excessive Temperatures in ME Equipment
201. 184.108.40.206 Applied Parts Intended to Supply Heat to a Patient
220.127.116.11.1.101 Requirements for Heating Devices Other Than Forced Air Devices
18.104.22.168.1.101.1 Maximum Contact Surface Temperature in Normal Condition
Applied parts of ME equipment intended to supply heat to a patient shall not have a contact surface temperature exceeding 40 °C in normal condition.
22.214.171.124.1.101.3 Maximum Contact Surface Temperature in Single Fault Condition
The surface temperature of a heating device shall not exceed 41 °C in single fault condition.
126.96.36.199.1.102 Requirements for Forced Air Devices
188.8.131.52.1.102.1 * Maximum Contact Surface Temperature in Normal Condition
When tested according to the methods described in Annexes FF and HH, the maximum contact surface temperature shall not exceed 48,0 °C and the average contact surface temperature shall not exceed 46,0 °C.
Any sensor whose position can be changed without the use of a tool shall not be used to control the maximum temperature which the controller can attain.
184.108.40.206.1.102.3 * Maximum Contact Surface Temperature in Single Fault Condition
The forced air device shall be equipped with a thermal cut-out to eliminate the risk of excessive contact surface temperature. The thermal cut-out shall activate within 10 min after the occurrence of the single fault condition described in Annex GG or when the contact surface temperature exceeds 56 °C.
The forced air device shall be equipped with an alarm system that includes at least a low priority technical alarm condition that indicates when the thermal cut-out has activated.
Consideration shall be given to lower limits or different risk control measures for forced air devices intended for infants.
201.15 Construction of ME Equipment
220.127.116.11.1.101 *Temperature and Overload Control Devices – Additional requirements for application
For liquid-filled devices, the contact surface temperature shall not exceed the limits in the following table, which does not apply to infants:
Table 201 .1 02 – Temperature Limits In Dependency To Time
For infants the temperature shall not exceed 43 °C.
Except for forced air devices and circulating liquid devices, the thermal cut-out shall prevent the contact surface temperature from exceeding 41 °C (see also 18.104.22.168.1.101.3).
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