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Health Sciences Authority
Dear Healthcare Professional Letters

Potential risk of nickel release above the acceptable Margin of Safety for EasyClip implants

Audiences

Healthcare professional

Industry member

Product type

Medical devices

7 October 2020

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

A Dear Healthcare Professional Letter has been issued by Stryker ASEAN to inform healthcare professionals that there is a risk of nickel release above the acceptable Margin of Safety for EasyClip implants in paediatric patients of body weight less than 20kg implanted with more than two Easyclip staples. This could lead to elevated development of nickel ion hypersensitivity subsequently. To date, Stryker is not aware of any complaints or incidents related to this potential risk. The Information for Use of the EasyClip implants will be updated with the necessary safety information. Healthcare professionals are advised to use a maximum of two implants in paediatric patients to maintain an acceptable margin of safety. No action is required for patients already treated with an affected device. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.

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