Using non-medical equipment in a medical context

Abstract

Sometimes it may seem appropriate to use a non-medical item of equipment in its normal mode of use but in a medical context. If this is to be done, it should be because the use demonstrates patient benefit and there must be a thorough risk assessment carried out, documented and approved at the relevant organizational level.

Keywords / Tags: Chemotherapy treatment; heat-pads; patient comfort; medical devices CE marking; medical electrical equipment standards.

Narrative

Chemotherapy treatment delivered in an out-patient setting is a common patient experience in cancer treatment. Some of the chemo infusions are very uncomfortable, painful even, and a heat pad over the arm at the site of the infusion gives substantial relief.

Heat pads for the domestic market, made to the IEC 60335-2-17 Standard are available and without any further consultation, nurses in the outpatients chemotherapy department had purchased some of these. They had been successfully used for about four years. However, they came to the notice of the both Control of Infection team who were concerned about issues around the fabric covering and the Estates Department who were concerned that they were not electrically safety tested. 

The outcome was that these heat pads were withdrawn from use. Patients then started to bring in their own heat pads but Estates removed the plugs from theses. As a consequence of the unavailability of electrically powered heat pads, water heated gel packs were then used.

Clinical Engineering were asked to investigate a source of a suitable heat pat made to the medical electrical equipment standard, IEC 80601-2-35. Only one device appropriate for this situation was identified on the market in the country concerned and this was CE marked to the EU Medical Devices Directive. A small number were purchased, though the cost per unit was nearly ten time that for the ‘domestic’ equipment.

These new heat pads proved to be very unreliable, with numerous faults and poor construction, which lead to very few being available for use on the units. The consequence was that the number of PIC lines that had to be inserted increased and the time-consuming and less effective use of heated gel packs had to continue.

Clinical Engineering suggested to the Medical Devices Committee (MDC) that, if a ‘domestic’ heat pad were used by a person sitting in an armchair in their own home, that would be considered entirely appropriate. That same person, sitting in an armchair in the hospitals day unit was in no substantially different situation and was being monitored by clinical staff. A thorough and careful risk assessment might show that it was acceptable to use this non-medical device for its intended purpose i.e. heating the persons arm, all be it in a hospital setting.

This risk assessment was carried out jointly between senior nursing staff, Clinical Engineering and the control of infection team and circulated at various draft stages within the MDC, with comments being taken into consideration. The control of infection team prescribed the use of hospital laundered pillow cases, changed between each patient, rather than the supplied and illustrated cotton cover. The risk to patients of continuing with the higher rate of PIC line insertions had to be assessed and compared to the risk of using a ‘non-medical’ heat pad. In order to further mitigate this very low risk, the risk assessment proposal included the development of a standard operating procedure (SOP) for the clinical use of the heat pad. The SOP included control of infection processes and a strict requirement that the heat pads were only to be used in the clinical setting of the outpatients day unit. Routine inspections and appropriate testing by Clinical Engineering were mandated.

The risk assessment method used a 5 by 5 scored severity vs. likelihood matrix as shown below. 

Note: Risk ratings of 5 or less are considered acceptable without further mitigation measures

The final risk assessment was presented and considered by the hospital’s Safety and Risk Committee and signed of by the hospital’s management Board. 

Adding value

This exercise was not primarily one of cost though, fortuitously, costs were reduced.

Value was added by the reduction of risk and the benefit to patients of being able to reinstate a safe and effective regime for the use of heat pads.

Patient centred

The key driver was, ‘What is best for the patient?’

Culture and ethics

The cultural shift was to move from saying, ‘This device is not approved for this use, therefore we cannot use it.’ to looking at the whole problem, taking all factors into consideration and proposing a solution. The ethical dimension was in carefully documenting the reasoning and then putting this to further scrutiny by the Risk and Safety Committee and ultimately by the Board.

Summary

The use of a non-medical heat pad was proposed as a means of providing a better and lower risk patient experience since there was no acceptable ‘medical Standard’ device available. The primary driver was to reduce pain, discomfort and other risks from patients by the use of these heat pads. The risk was compare to the risk of continuing with a higher rate of PIC line insertions and increased patient discomfort.

The risk assessment document was drafted by both nursing and Clinical Engineering staff with review and input from other members of the MDC. An agreed final version was put to the hospital’s Board and approved.

References

IEC. 2012.  IEC 60335-2-17:2102 Household and similar electrical appliances – Particular requirements for blankets, pads, clothing and similar flexible heating appliances. Geneva, Switzerland: IEC

IEC. 2009. IEC 80601-2-35:2009 Medical electrical equipment – Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use. Geneva, Switzerland: IEC

Self directed learning 

1.  What were the key points that made it acceptable to implement this course of action?