Boots 56-90-447 (HEM-7101)

Description:

The Boots 56-90-447 (HEM-7101) is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.

Assessment:

While the technology used in the Boots 56-90-447 (HEM-7101), to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP	BIHS (UK and IRL)	Previous recommendation, now archived	Manufacturer declaration of equivalence
BP	ESH (Europe)	Self-measurement	The BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.

Device Family:

Boots 56-90-447 (HEM-7101)B, Omron MX3 Plus (HEM-742-E)B
Legend: B BIHS Derivative

Relevant Publications:

Ware A, Stevens R, Selwood M, Fleming S. Accuracy of blood pressure monitors available in high street pharmacies. Blood Press Monit. 2016 Feb;21(1):59-61. doi: 10.1097/MBP.0000000000000151. PMID: 26427055.

Measurements from the Boots 5690447 are compared to those from the Omron PA-350 (BPM tester), though not in a formal validation.

Validation Publications for Equivalent Devices:

Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.

Omron MX3 Plus (HEM-742-E)

Coleman A, Freeman P, Steel S, Shennan A. Validation of the Omron MX3 Plus oscillometric blood pressure monitoring device according to the European Society of Hypertension international protocol. Blood Press Monit. 2005 Jun;10(3):165-8. PMID: 15923819.

ESH-IP:2002 - Pass General population

Christofaro DG, Casonatto J, Polito MD, Cardoso JR, Fernandes R, Guariglia DA, Gerage AM, de Oliveira AR. Evaluation of the Omron MX3 Plus monitor for blood pressure measurement in adolescents. Eur J Pediatr. 2009 Nov;168(11):1349-54. Epub: 2009 Feb 17. doi: 10.1007/s00431-009-0936-x. PMID: 19221789.

BHS:1993 - Pass (A/A) General population

SP10:1996 - Pass General population