Hand pieces used with oral / maxillofacial surgery drills - ensure maintenance procedures are in place to prevent drill from overheating

(General) significant increase in the number of reports from patients receiving oral burns from hand pieces used with overheated drills mostly due to lack of appropriate maintenance. (MDA/2006/055)

21 September 2006 at 14:00

MDA/2006/055

Action deadlines for the Safety Alert Broadcast System (SABS)

Deadline (action underway): 20 October 2006, Deadline (action complete): 21 November 2006

Device

Handpieces used with oral / maxillofacial surgery drills.

Problem

Lack of appropriate maintenance leading to overheating and oral burns.

Over the past few years there has been a significant increase in the number of reports of oral burns to patients from overheating drill handpieces during maxillofacial surgery. The reports have come from several sources and involve devices from various manufacturers. The majority of incidents involve the cone end of the handpiece heating up close to the bur holder. In most of the devices that were returned for analysis, the bearings in that location were shown to be in sub-standard condition. This was generally accompanied by a lack of appropriate maintenance. It should be kept in mind that the bearings used in oral / maxillofacial surgery handpieces tend to be smaller and more fragile than standard dental handpieces.

Reference is made to the importance of planned preventative maintenance in the MHRA Device Bulletin DB 2000(02) ‘Medical Devices and Equipment Management: Repair and Maintenance Provision’, Medicines and Healthcare products Regulatory Agency, June 2000.

Action

By users of surgical dental drills:

  • Always use an ISO standard bur, with diameter and length as specified in the user instructions
  • Before using the handpiece, run it to check that it is running true (i.e. no noise, not loose, no damage, etc.) and to check for any abnormalities, including heating

By dental laboratory/operating theatre managers:

  • Check the bearings at least annually
  • Consider a service contract with the appropriate manufacturer, supplier or agent
  • Follow the manufacturer’s instructions on cleaning, lubrication and maintenance
  • Provide appropriate instructions and training to sterile services departments or third parties who carry out decontamination procedures

Action by

Maxillo-facial surgeons, cosmetic surgeons, dental surgeons, theatre managers.

Distribution

Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:

Trusts to:

SABS liaison officers for onward distribution to all relevant staff including:

  • Cosmetic surgeons
  • Dental departments
  • Dental nurses
  • Dental surgeons
  • Dental surgery units
  • Equipment stores
  • Maintenance staff
  • Maxillofacial surgeons
  • Medical directors
  • Oral surgery departments
  • Outpatient theatre managers
  • Outpatient theatre nurses
  • Sterile services departments
  • Supplies managers
  • Theatre managers
  • Theatre nurses
  • Theatres

Healthcare Commission (CHAI) to:Headquarters for onward distribution to:

  • Acute hospitals in the independent sector
  • Hospitals in the independent sector
  • Independent treatment centres
  • Private medical practitioners

Primary care trusts to:

SABS liaison officers for onward distribution to all relevant staff including:

  • Community dental practices
  • Community hospitals
  • Equipment libraries and stores
  • General dental practitioners
  • Maintenance staff
  • Practice managers

Contacts

Enquiries to the MHRA should quote reference number 2006/007/005/291/003 and be addressed to:

Technical aspects

Dr Sandra Costigan or Mr Ian Smith
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ

Tel: 020 7084 3281/3306
Fax: 020 7084 3209

E-mail: sandra.costigan@mhra.gsi.gov.uk & ian.smith@mhra.gsi.gov.uk

Clinical aspects

Jonathan Plumb
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ

Tel: 020 7084 3128
Fax: 020 7084 3111

E-mail: jonathan.plumb@mhra.gsi.gov.uk

Change of address or removal from address list for Healthcare Commission:

Healthcare Commission
Finsbury Tower
103-105 Bunhill Row
London
EC1Y 8TG

Tel: 020 7448 0842

E-mail: contacts@healthcarecommission.org.uk

How to report adverse incidents

Incidents relating to medical devices must be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) as soon as possible.

Further information about reporting incidents; online incident reporting facilities; and downloadable report forms are available from MHRA’s website (http://www.mhra.gov.uk).

Alternatively, further information and printed incident report forms are available from:

MHRA Adverse Incident Centre
Medicines and Healthcare products Regulatory Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ

Telephone 020 7084 3080 or Fax 020 7084 3109 or e-mail: aic@mhra.gsi.gov.uk(An answerphone service operates outside normal officer hours)

Medical Device Alerts are available in full text on the MHRA website:http://www.mhra.gov.uk

Further information about SABS can be found at www.info.doh.gov.uk/sar2/cmopatie.nsf

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