PART 4 QUALITY AND SAFETY OF SERVICE PROVISION IN RELATION TO REGULATED ACTIVITY

16 Safety, availability and suitability of equipment
1 The registered person must make suitable arrangements to protect service users and others who may be at risk from the use of unsafe equipment by ensuring that equipment provided for the purposes of the carrying on of a regulated activity is—
(a) properly maintained and suitable for its purpose; and
(b) used correctly.
2 The registered person must ensure that equipment is available in sufficient quantities in order to ensure the safety of service users and meet their assessed needs.
3 Where equipment is provided to support service users in their day to day living, the registered person must ensure that, as far as reasonably practicable, such equipment promotes the independence and comfort of service users.
4 For the purposes of this regulation—
(a) “equipment” includes a medical device; and
(b) “medical device” has the same meaning as in the Medical Devices Regulations 2002.
S.I. 2002/618; the relevant amending instrument is S.I. 2008/2936.