Archived – Association of Absorbable Hemostatic Agents with Paralysis or Other Neural Deficits – Notice to Hospitals

Starting date:

May 7, 2004

Posting date:

May 7, 2004

Type of communication:

Notice to Hospitals

Subcategory:

Medical Device

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

Hospitals

Identification number:

RA-17000740

Notice about Health Canada advisories

NOTICE TO HOSPITALS - Health Canada Endorsed Important Safety Information on ABSORBABLE HEMOSTATIC AGENTS

May 7, 2004

To: Hospital Chief of Medical Staff

Please distribute to the relevant Departments of General and Plastic Surgery, Vascular Surgery, Orthopaedics, Neurosurgery, Obstetrics- Gynaecology, Dentistry and other involved professional staff and post this NOTICE in your institution.

Subject: Association of Absorbable Hemostatic Agents with paralysis or other neural deficits

Absorbable hemostatic agents are medical devices used to promote coagulation and stop internal bleeding during surgical procedures. When used on or near a bony or neural space and left inside the patient, the devices swell and may exert pressure on neural structures, resulting in pain, numbness or paralysis. The hemostatic agents can also migrate and cause embolization when entering the intra vascular space. These are rare events that may be preventable but continue to occur despite specific advice and warning in the device labelling.

There have been international reports of adverse events related to absorbable hemostatic agents. For example, the Food and Drug Administration of the USA has received over 110 reports since 1996, and eleven of these events resulted in paralysis or other neural deficits^{Footnote 1}. Although no such problems have been reported to the Health Products and Foods Branch, Health Canada considers it is important to remind health care professionals of this potentially serious adverse event.

The following are examples of absorbable hemostatic agents licensed in Canada:

Gelfoam (Pharmacia & Upjohn)

Surgicel fibrillar absorbable hemostat (Johnson & Johnson)

Surgifoam absorbable gelatin powder/sponge (Ferrosan A/S).

Recommendations:

In order to reduce the risk of neural deficits Health Canada recommends that surgeons who use absorbable hemostatic agents should pay particular attention to the contraindications, warnings and precautions listed in the label of the agent used.

If an absorbable hemostatic agent is used on or near bony or neural spaces:

• use the minimum amount of absorbable hemostatic agent necessary;
• make sure hemostasis is achieved before closing the wound; and
• remove as much of the agent as possible after hemostasis is achieved.

Health Canada depends on the participation of health care professionals in reporting device-related adverse incidents so that corrective action can be taken. Problems with medical devices should be reported to Health Canada at the following address:

Health Products and Food Branch Inspectorate

HEALTH CANADA

Address Locator: 3002C

Ottawa, Ontario K1A 0K9

Tel: The Medical Devices Hotline 1-800-267-9675

For other inquiries: please refer to contact information.

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada web site.